Recall roundup: 11 Apr – 17 Apr 2022
166 official recalls and safety alerts were published in the week of 11 Apr – 17 Apr 2022, down 17% on the week before (199). Most were drugs & medical (55) and vehicles (38); common issues included fire hazard (6), battery (5), salmonella (5). 38 were flagged as serious.
Recalls this week
11 Apr – 17 Apr 2022
By country
By product type
Common searches
Most serious
Recalls the agency classed as serious, or with a risk of death, fire, electric shock, drowning or strangulation.
- 2022-04-15
HR
EUPortable battery pack (GREYP) · Greyp 700WH battery pack
Due to manufacturing defects, there may be foreign conductive objects inside the battery; when charging, the battery cells may short-circuit and overheat. Furthermore, force needs to be applied on the battery modules…
DEEUPassenger car (VW) · Arteon, Golf, Passat, Tiguan, T-Roc
The engine covers installed on affected vehicles could detach from their fixings depending on the conditions of use (e.g. very sporty driving, or poor road surfaces) and their age. A loose engine cover could come into…
BEEUPersonal watercraft (Sea-Doo)
The tabs of the portable audio system may break, causing it to dislodge from its support.Consequently, the audio system may hit the user and/or passenger, leading to injuries. The product does not comply with the…
HUEUChristmas tree with lighting chain · LAMPKI CHOINKOWE LED
The cable is not properly anchored and is too thin. The accessible wires have inadequate insulation. The dimensions of the mains plug are substantially less than required. The product is not protected against moisture.…
EU Safety Gate · reported by HungaryOfficial notice →- HUEU
Lighting chain · fény-fa
The cable is not properly anchored and is too thin. The accessible wires have inadequate insulation. The cable could overheat, leading to burns or fire. The user could touch accessible live parts, which may cause an…
EU Safety Gate · reported by HungaryOfficial notice → - HUEU
Night light (LE ROYAL) · LED COPPER LAMP
The light source can be unscrewed without removing the luminaire from the mains socket. As a result, live parts become accessible and this could lead to an electric shock. The product does not comply with the…
LTEULighting chain · Garland 100 LED bulbs
The cable is not properly anchored, the conductors in the wires are too thin, and the distance between the plug and the first lamp or lampholder is too short. Furthermore, the control device cap can be easily removed.…
EU Safety Gate · reported by LithuaniaOfficial notice →- DEEU
Passenger car (Skoda) · Kodiaq, Octavia, Superb
Engine design covers installed on affected vehicles could come loose from the attachment depending on use (e.g. very sporty driving style or poor road surface conditions) and the running time. If the design cover is…
- DEEU
Passenger car (VW) · Arteon, Golf, Passat, Tiguan, T7
The amount of extinguishing sand in the fuse of the high-voltage system is not sufficient in the event of a short circuit to the high-voltage safety system. This may cause it to burst, increasing the risk of injuries.…
- DEEU
Passenger van / Light commercial vehicle (Mercedes-Benz) · Sprinter
The wiring harness of the generator may have been erroneously swapped with the wiring harness of the electric steering during assembly. Consequently the steering wiring harness would be secured with the generator fuse…
United States 86
- 2022-04-15
USAutocar, LLC: Hazard Lights Disabled When Ignition Is Off
Inoperable hazard lights increase the risk of a crash.
- US
Mercedes-Benz USA, LLC: Headlight Failure
Headlight failure can decrease visibility for both the driver and surrounding traffic, increasing the risk of a crash.
- US
Tiny Idahomes LLC: Coupler Improperly Welded
Trailer separation from a tow vehicle can increase the risk of a crash.
- 2022-04-14
- US
Nissan North America, Inc.: Improperly Manufactured Fuel Tank
Road debris may puncture the thin fuel tank wall, causing a gas leak and increasing the risk of a fire. In addition, the fuel tank may not perform as expected during a crash, increasing the risk of injury.
- US
Hyundai Motor America: Hydrogen Gas Detection Sensors May Fail
A hydrogen gas leak can increase the risk of a fire while parked or driving.
- US
Bentley Motors, Inc.: Second Row Seats Not Correctly Installed
An unlocked seat rail could move in the event of a crash, increasing the risk of injury to occupants.
- US
Ford Motor Company: Unintentional Rollaway Due to Transmission Washer
Debris lodged within the 'Park' mechanism may prevent the vehicle from achieving or holding 'Park,' increasing the risk of a vehicle rollaway and a crash.
- US
Ford Motor Company: Vehicle Rollaway from Driveshaft Disconnect
A disconnected driveshaft can result in vehicle rollaway when the vehicle is placed in 'Park' without the parking brake applied, increasing the risk of a crash.
- US
Ford Motor Company: Unintentional Rollaway Due to Detached Shift Cable
A damaged or missing bushing may prevent the vehicle from shifting into the intended gear, and cause the vehicle to move in an unexpected direction. Additionally, the vehicle may roll after the driver selects the…
- US
Ford Motor Company: Steering Column Wiring Too Short
Damaged or separated wiring may result in the steering column not moving as intended in certain crash conditions, increasing the risk of injury in a crash.
- US
Ford Motor Company: Rearview Camera Image May Not Display/FMVSS 111
A rearview camera that displays a blank or distorted image can reduce the drivers view of what is behind the vehicle, increasing the risk of a crash.
- US
Ford Motor Company: Windshield Wipers May Fail
Inoperative windshield wipers can reduce visibility in certain driving conditions, increasing the risk of a crash.
- US
Chrysler (FCA US, LLC): Turn Signal Malfunction/FMVSS 108
If a turn signal fails, the driver will not be informed and surrounding drivers will not receive indication of the intention to change vehicle direction, which can increase the risk of a crash.
- US
Chrysler (FCA US, LLC): Head Restraints Not Welded Properly/FMVSS 202
Improperly welded head restraints can result in an increased risk of injury to seat occupants during a crash.
- US
Ford Motor Company: Head Restraint Cushion May Detach
A detached head restraint cushion can increase the risk of injury during a crash.
- US
General Motors, LLC: Driver's Air Bag Inflator May Explode
An inflator explosion may result in sharp metal fragments striking the driver or other occupants, resulting in serious injury or death.
- US
Dollar Tree Recalls More than One Million Hot Glue Guns Due to Fire and Burn Hazards
The glue gun can malfunction when plugged in, posing fire and burn hazards.
- US
MTD Recalls Craftsman and Troy-Bilt Riding Lawn Mowers Due to Crash Hazard
The riding mowers can fail to come to a complete stop and continue to move at a speed of about one mile per hour when the clutch/brake pedal is fully depressed, posing a low speed crash hazard.
- US
Telebrands Recalls Hempvana Pain Relief Products with Lidocaine Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
The products contain the substance lidocaine which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of…
- US
GE Appliances, a Haier Company, Recalls Bottom Freezer, French Door Refrigerators Due to Fall Hazard
The freezer handle can detach when a consumer tries to open the freezer drawer, posing a fall hazard to the consumer.
- US
MerchSource Recalls FAO Schwarz Branded Toy Wood Play Smart Robot Buddy(s) and Wood Sensory Boards Due to Choking Hazard
Due to a manufacturing issue, small parts from the products can come loose, posing a choking hazard to young children.
- US
Diving Inflation Valves Recalled Due to Risk of Hypothermia; Manufactured by SI TECH
The internal part in the valve can malfunction while in use, causing loss of inflation and thermal protection, posing a risk of hypothermia to the consumer.
- US
Rae Wellness Recalls Prenatal and Immunity Dietary Supplements Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
The products are dietary supplements containing iron which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a…
- 2022-04-13
- US
Volkswagen Group of America, Inc.: Missing Fuel Injector Filter May Cause Fuel Leak
Long fuel injectors with missing filters may leak fuel, increasing the risk of a fire.
- US
Nissan North America, Inc.: Headlight Aim May Be Misaligned/FMVSS 108
An improperly aimed headlight may reduce the driver's visibility, increasing the risk of a crash.
- US
Forest River, Inc.: Cracked LP Gas Quick Disconnect Fitting
A gas leak in the presence of an ignition source can increase the risk of a fire.
- US
Keystone RV Company: Furnace Vent Extension Not Installed
Carbon monoxide inside the vehicle can increase the risk of injury or death.
- US
FRONTRUNNER BUS GROUP, INC.: Programmable Relay Power Center Module Failure
Failure of the Programmable Relay Power Center (PRC) increases the risk of a fire.
- US
BMW of North America, LLC: Airbag Control Unit Software Malfunction
An air bag malfunction indicator light that fails to warn the driver of a problem increases the risk of injury in a crash.
- US
Toyota Motor Engineering & Manufacturing: Stability Control Deactivated on Startup/FMVSS 126
Driving with a deactivated stability control system increases the risk of a crash.
- US
Toyota Motor Engineering & Manufacturing: Missing Welds May Cause Shock Absorber to Separate
A separated shock absorber can cause a loss of vehicle stability, increasing the risk of a crash.
- US
Bendix Commercial Vehicle Systems, LLC: Brake Light Switch Malfunction
Brake lights that do not operate as intended can cause confusion to other drivers, increasing the risk of a crash.
- US
NTN Bearing Corporation of America: Driveshaft Failure Due to Improper Heat Treatment
Driveshaft failure can cause a sudden loss of drive power, increasing the risk of a crash.
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV…
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide Distribution was made to KY, OK, and TX. There was no…Official notice → - US
Maquet Medical Systems USA recalls Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump…
Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly,…
FDA · DeviceMaquet Medical Systems USAUS Nationwide Distribution: FL, KY, NH, NJ, NY, PA, TX, VA Foreign: Belgium,…Official notice → - US
DRG International, Inc. recalls C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
- US
Abbott recalls Amplatzer Steerable Delivery Sheath
Instructions for use were updated.
- US
Ventana Medical Systems Inc recalls BenchMark ULTRA and DISCOVERY ULTRA Instruments
Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.
FDA · DeviceVentana Medical Systems IncUS: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND,…Official notice → - US
Siemens Medical Solutions USA, Inc. recalls Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
FDA · DeviceSiemens Medical Solutions USA, Inc.Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.Official notice → - US
WHPM Inc. recalls First SIGN SARS-CoV-2 Antigen Test
Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization,…
- US
Abbott Laboratories recalls ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT…
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
FDA · DeviceAbbott LaboratoriesWorldwide Distribution: US (nationwide) and OUS (foreign) including countries…Official notice → - US
Brius Technologies Inc. recalls Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made…
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
- US
Maquet Cardiovascular, LLC recalls Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX,…Official notice → - US
Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to…
FDA · DeviceVolcano CorporationUS: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX,…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)
There is a potential for misquantitation high results for negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m HBV Application Specification File (US and CE)
There is a potential for misquantitation high results of negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice → - US
Philips North America LLC recalls Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may…
FDA · DevicePhilips North America LLCWorldwide distribution. US Nationwide including Puerto Rico and Guam, Germany,…Official notice → - US
DeRoyal Industries Inc recalls DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the…
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
FDA · DeviceDeRoyal Industries IncUS distribution to Florida, New Jersey, and TennesseeOfficial notice → - US
Hologic, Inc recalls Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
FDA · DeviceHologic, IncUS: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA,…Official notice → - US
Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP…
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
FDA · DeviceCook Medical IncorporatedUS Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile GuamOfficial notice → - US
Philips North America Llc recalls Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063,…
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from…
- US
Draeger Medical, Inc. recalls Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog…
Cybersecurity Improvement Action-not equipped against potential cyber security threats
- US
Shimadzu Medical Systems recalls MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
FDA · DeviceShimadzu Medical SystemsU.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN,…Official notice → - US
Stradis Medical, LLC dba Stradis Healthcare recalls Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareUS Nationwide distribution in the states of IN, TX, and PA.Official notice → - US
Remote Diagnostic Technologies Ltd. recalls Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
FDA · DeviceRemote Diagnostic Technologies Ltd.US Nationwide distribution in the states of IL and KS.Official notice → - US
GE Healthcare, LLC recalls Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
There is potential for the images to be flipped left to right.
FDA · DeviceGE Healthcare, LLCWorldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan,…Official notice → - US
SA3, LLC recalls Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Due to failure of microbial testing for total aerobic microbial count (TAMC).
- US
GE Healthcare, LLC recalls Revolution Apex, Revolution CT with Apex Edition
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
- US
Philips Healthcare recalls Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system,…
- US
Siemens Medical Solutions USA, Inc recalls YSIO X.Pree
For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide, Worldwide distributionOfficial notice → - US
Fruit Fresh Up, Inc. recalls 1. Wegmans 10oz Watermelon Chunks 2. Wegmans 32oz Watermelon Chunks 3.Fresh Harvest 18oz Watermelon Chunks 4. Tops Large Watermelon BBD:…
may be contaminated with Listeria monocytogenes
- US
Taylor Farms Southwest, Inc recalls Thai Noodle Salad Kit 108 oz. bag (behind the counter salad), UPC 0 30223 11270 9, Taylor Farms Southwest, 859 S. 86th Ave,…
This recall is a result of a supplier recalling an ingredient supplied to us, Thai Noodle Salad. They identified the potential for it to be contaminated with pieces of clear plexiglass.
- US
Garden Highway Southwest, LLC (GHSW, LLC) recalls Asian Style Noodle Salad Net Wt. 1 lb (16 oz) 463 g PERISHABLE KEEP REFRIGERATED packaged in plastic clamshells
Potential to contain foreign material, plastic.
- US
Chattanooga Coca Cola Bottling Company dba United Packers,… recalls Powerade Zero - Grape 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the…
The product incorrectly contains sugar, which is not declared on the label.
FDA · FoodChattanooga Coca Cola Bottling Company dba United Packers,…Distributor in TNOfficial notice → - US
Bread Alone, Inc. recalls Bread Alone Fruit & Nut Sourdough; packaged in 27 ounce plastic bag
Product contains undeclared sulfites.
- US
Top Quality Produce, Inc recalls Top Quality Produce Enoki Mushrooms; 200G/7.05 oz. clear package with green bottom. Vacuumed packed Product of Taiwan. Keep…
California Department of Public Health tested Enoki mushrooms and had a positive result for Listeria monocytogenes.
- US
Sauer Brands Inc - New Century recalls Caesar dressing in a 1.5 oz pouch
Undeclared Allergen - Soy
FDA · FoodSauer Brands Inc - New CenturyInstitutional/Foodservice accounts in multistate region: LA, TN, TX, GA, VA,…Official notice → - US
T Fresh Company DBA Yes Produce recalls Yes! Enoki Mushrooms; Pesticide Free Produce: Vacuumed packed. Product of China 5.29 oz. (150g) packaged in pink and transparent…
California Department of Public Health sampled product with a result of Listeria monocytogenes
- US
GH FOODS GA, LLC. recalls Asian Style Noodle Salad, Net Wt 1lb (16oz) 453 g PERISHABLE, KEEP REFRIGERATED CONTAINS: SOY, TREE NUTS (ALMONDS), WHEAT. Distributed By:…
The firm was notified by their supplier that one of their ingredients may contain clear plastic objects.
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box,…
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
- US
Adamis Pharmaceuticals Corporation recalls SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only,…
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
- US
Macleods Pharma Usa Inc recalls Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536,…
FAILED CONTENT UNIFORMITY SPECIFICATIONS
- US
Pfizer Inc. recalls quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977,…
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- US
Sandoz, Inc recalls Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC…
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
- US
Jubilant Cadista Pharmaceuticals, Inc. recalls Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc.…
Subpotent
FDA · DrugJubilant Cadista Pharmaceuticals, Inc.Nationwide in the USA and Puerto RicoOfficial notice → - US
Revive Personal Products Company recalls The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Products…
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
- US
- US
Mylan Pharmaceuticals Inc recalls Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV…
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine…
- US
Advanced Accelerator Applications USA, Inc. recalls NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial…
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
FDA · DrugAdvanced Accelerator Applications USA, Inc.Nationwide in the USA and Puerto RicoOfficial notice → - US
MERCK SHARP & DOHME CORP recalls Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale,…
Presence of foreign substance: Presence of stainless steel particulates in tablets.
- US
The Ritedose Corporation recalls 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A…
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
- US
Vitae Enim Vitae Scientific, Inc. recalls TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for…
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-12
- US
Prevost Car (US) Inc.: Passenger Bench Seat Frame Bolts May Be Loose
Loose seat frame bolts may allow the seat to move, increasing the risk of injury during a crash.
- US
Prevost Car (US) Inc.: Frayed Passenger Seat Belt Buckle Wires
A damaged seat belt assembly may not buckle properly, increasing the risk of injury during a crash.
- US
Tesla, Inc.: Pedestrian Warning Sound May Be Obscured/FMVSS 141
Pedestrians may be unaware of an approaching vehicle if the PWS sounds are obscured, increasing the risk of a crash.
- 2022-04-11
- US
Newmar Corporation: Wiring Under Seat Not Secured Properly
A short circuit increases the risk of a fire.
Canada 29
- 2022-04-14
CA- CA
Sotrovimab for Injection - Risk of Treatment Failure due to Circulation of SARS-CoV-2 Omicron BA.2 Subvariant
New safety information - COVID
Health CanadaOfficial notice → - CA
Distribution of EVUSHELD (tixagevimab and cilgavimab for injection) with English-Only Vial and Carton Labels
Labelling - Supply - COVID
Health CanadaOfficial notice → - CA
Crafter’s Square Mini Hot Glue Gun Recalled due to fire and Burn Hazards
Burn hazard - Fire hazard
Health CanadaOfficial notice → - CA
- CA
GE Brand Bottom Freezer, French Door Refrigerators Recalled Due to Fall Hazard
Fall hazard
Health CanadaOfficial notice → - 2022-04-13
- CA
Terex equipment recall: other (Transport Canada 2018051)
Problem area: other. The Transport Canada notice lists the affected models and model years, and what the manufacturer will do.
Transport CanadaOfficial notice → - CA
- CA
- 2022-04-12
- CA
- CA
- CA
- 2022-04-11
- CA
- CA
- CA
- CA
- CA
- CA
- CA
- CA
- CA
Percept Pc Brainsense Deep Brain Stimulation Implantable Neurostimulator
Software defect
Health CanadaOfficial notice → - CA
- CA
- CA
- CA
- CA
- CA
- CA
- CA
United Kingdom 6
- 2022-04-14
UKAngle Grinder Chainsaw Discs sold via eBay (2204-0061 and 2204-0062)
Risk of serious injury and fatality
- UK
- UK
Angle Grinder Chainsaw Discs sold via AliExpress (2203-0068, 2203-0325, 2203-0335, 2203-0340, 2203-0303, 2203-0072)
Risk of serious injury and fatality
- UK
Tesco recalls Tesco Chicken and Vegetable cup soup with croutons because it may contain small pieces of metal
It may contain small pieces of metal
- UK
Baxters Food Group Ltd recalls Fray Bentos Just Chicken Pie because it may contain small pieces of plastic
It may contain small pieces of plastic
- UK
Interdragon International Trading Co and Asia Oriental Market recalls two products because they contain allergens which are not declared in English
They contain allergens which are not declared in english
Australia 6
- 2022-04-14
AUColes Baby Spinach
Food products contaminated with Salmonella may cause illness if consumed.
- AU
Batec Mini, Mini 2, Scrambler 2 and Electric 2 Handbikes
If the bolts become loose or fall out, the brake may not work as expected, increasing the risk of an accident resulting in injury.
- AU
KIPRUN GPS 500 and KIPRUN GPS 550 Watches
If the battery overheats, there is a risk of burns to the user who is wearing the watch or a fire resulting in serious injuries or death.
- 2022-04-12
- AU
Garden Fortune Cookies 140g
Food products contaminated with naphthalene may cause illness if consumed.
- AU
Glass Pool Fence Latch
If the gate latch is not closed correctly and the gate remains unlatched, it may not prevent unsupervised access to the pool or spa area posing a risk of drowning.
- 2022-04-11
- AU
Spa Quip 800 and 1200 Spa Controllers
Risk of electric shock, which can cause serious injury or death. There has been a fatality associated with this product.
New Zealand 3
- 2022-04-14
NZBosch NanoBlade Saws and Replacement Blades
The NanoBlade saws do not comply with the Unsafe Goods Notice (Chainsaws without a Chain Brake Indefinite Prohibition Notice 2012) as they do not have a chain brake.
Product Safety NZOfficial notice →- 2022-04-12
- NZ
Kaffelogic Nano7 Coffee Roaster
There is a risk of electric shock hazard from metal USB port.
Product Safety NZOfficial notice → - 2022-04-11
- NZ
UBCO 2X2
The Annulus Gear, a component of the wheel hub, may loosen during operation causing abnormal contact between the gear and hub motor. If this abnormal contact occurs while the bike is in motion, the affected wheel may…
Product Safety NZOfficial notice →
EU & EEA 36
- 2022-04-15
- HREU
Portable battery pack (GREYP) · Greyp 700WH battery pack
Due to manufacturing defects, there may be foreign conductive objects inside the battery; when charging, the battery cells may short-circuit and overheat. Furthermore, force needs to be applied on the battery modules…
- DEEU
Bracelets set · Set mehrere Armbänder aus goldfarbenen Ketten mit vers. Anhänger in Blumen, Herzen, und…
The product contains an excessive amount of cadmium (measured value: 55% by weight). Cadmium is harmful to human health because it accumulates in the body, may damage the kidneys and the bones, and is carcinogenic. The…
EU Safety Gate · reported by GermanyOfficial notice → - DEEU
Hair jewellery · Modeschmuck Keltischer Haar Schmuck 2 Spiralen im Set Kringelförmig silber
The product contains an excessive amount of cadmium (measured value: 90% by weight). Cadmium is harmful to human health because it accumulates in the body, may damage the kidneys and the bones, and is carcinogenic. The…
EU Safety Gate · reported by GermanyOfficial notice → - DEEU
Bracelet · 202 Armband mit Drachenkopf in silber. 2 einzelne Drachenköpfe mit Schließmechanismus
The product contains an excessive amount of cadmium (measured value: 95% by weight). Cadmium is harmful to human health because it accumulates in the body, may damage the kidneys and the bones, and is carcinogenic. The…
EU Safety Gate · reported by GermanyOfficial notice → - DEEU
Passenger car (VW) · Arteon, Golf, Passat, Tiguan, T-Roc
The engine covers installed on affected vehicles could detach from their fixings depending on the conditions of use (e.g. very sporty driving, or poor road surfaces) and their age. A loose engine cover could come into…
FREUToy torch with sweets (Mada Sweet) · Johny Bee Torch Spray
The toy can easily break, leaving the button batteries accessible. A child could put them in the mouth, which could cause damage to the child’s gastrointestinal tract or choking. The product does not comply with the…
- FREU
Passenger car (Tesla) · Model S
On some Model S vehicles, the latch assembly of the front hood may be aligned too far rearward. While this alignment does not impact latching of the primary latch with the hood striker, it may prevent latching of the…
IEEUChildren's watch (Smiggle) · Smiggle Fun Character Slapband Watch
The button battery compartment of the product may not be adequately secured and the button battery may be accessible by children. A child may put it in the mouth, which could cause damage to the child’s…
- LTEU
Helmet (Polisport Sport Ride) · Helmet for cyclists
The helmet can easily break during an impact, thus not sufficiently protecting the user from injuries to the head. The product does not comply with the Personal Protective Equipment Regulation nor with the European…
- BEEU
Particle filter mask · Semimaschera filtrante
The particle/filter retention of the material is insufficient (measured values: as low as 74%). Consequently, the product does not fulfil the health and safety requirements; thus, even if combined with other…
EU Safety Gate · reported by BelgiumOfficial notice → - BEEU
Personal watercraft (Sea-Doo)
The tabs of the portable audio system may break, causing it to dislodge from its support.Consequently, the audio system may hit the user and/or passenger, leading to injuries. The product does not comply with the…
PLEUToy slime (Midex) · Gadzet rozrywkowy
The migration of boron from the toy is too high (measured value up to 1133 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system. The…
- PLEU
Toy slime (Midex) · Gadzet rozrywkowy
The migration of boron from the toy is too high (measured value up to 1177 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging their reproductive system. The…
BGEUDisposable electronic cigarette (Soul) · Apple mint and Bubble gum
The product is not protected against breakage. Nicotine is acutely toxic and can endanger the user’s safety, if the product comes accidentally into contact with the skin or is ingested. Furthermore, the mouthpiece…
- BGEU
Rechargeable Electronic cigarette (Vaptio) · Vaping Marathon LIGH UP YOR LIFE
The product tank volume exceeds 2 ml. This could lead to the accidental consumption of a high dose of nicotine. Nicotine is acutely toxic in high doses and its inhalation can cause adverse effects on the health.…
- HUEU
Christmas tree with lighting chain · LAMPKI CHOINKOWE LED
The cable is not properly anchored and is too thin. The accessible wires have inadequate insulation. The dimensions of the mains plug are substantially less than required. The product is not protected against moisture.…
EU Safety Gate · reported by HungaryOfficial notice → - HUEU
Lighting chain · fény-fa
The cable is not properly anchored and is too thin. The accessible wires have inadequate insulation. The cable could overheat, leading to burns or fire. The user could touch accessible live parts, which may cause an…
EU Safety Gate · reported by HungaryOfficial notice → - HUEU
Night light (LE ROYAL) · LED COPPER LAMP
The light source can be unscrewed without removing the luminaire from the mains socket. As a result, live parts become accessible and this could lead to an electric shock. The product does not comply with the…
- FREU
Passenger car (Peugeot) · 2008, 208
The open circuit detecting system on the high voltage circuit may be over-sensitive and could unnecessarily cut off the electric current. As a result, the vehicle may lose power during driving, increasing the risk of…
- BGEU
Disposable electronic cigarette (ЕРА) · WATERMELON ICE
The product volume exceeds 2 ml. This could lead to the accidental consumption of a high dose of nicotine. Nicotine is acutely toxic in high doses and its inhalation can cause adverse effects on the health. The product…
- LTEU
Lighting chain · Garland 100 LED bulbs
The cable is not properly anchored, the conductors in the wires are too thin, and the distance between the plug and the first lamp or lampholder is too short. Furthermore, the control device cap can be easily removed.…
EU Safety Gate · reported by LithuaniaOfficial notice → - DEEU
Passenger car (Skoda) · Kodiaq, Octavia, Superb
Engine design covers installed on affected vehicles could come loose from the attachment depending on use (e.g. very sporty driving style or poor road surface conditions) and the running time. If the design cover is…
- DEEU
Passenger car (VW) · Arteon, Golf, Passat, Tiguan, T7
The amount of extinguishing sand in the fuse of the high-voltage system is not sufficient in the event of a short circuit to the high-voltage safety system. This may cause it to burst, increasing the risk of injuries.…
- DEEU
Passenger van / Light commercial vehicle (Mercedes-Benz) · Sprinter
The wiring harness of the generator may have been erroneously swapped with the wiring harness of the electric steering during assembly. Consequently the steering wiring harness would be secured with the generator fuse…
- DEEU
Passenger car (Opel) · Corsa
Vehicles are equipped with wrong wheel screw/s. This may lead to vibration and to the loosening of the wheels during lifetime, increasing the risk of an accident. The product does not comply with the Regulation on the…
- DEEU
Particle filter mask (ICE Pro Mask) · ICE PRO MASK
The particle/filter retention of the material is insufficient (measured values: as low as 51%). Consequently, the product does not fulfil the health and safety requirements; thus, even if combined with other…
ROEUFalse nails (Dudustrong)
According to the list of ingredients, the glue contains dibutyl phthalate (DBP), which use is forbidden in cosmetic products. This phthalate may harm the health, causing possible damage to the reproductive system or…
- PLEU
Plastic doll · Brianna
The toy contains bis (2-ethylhexyl) phthalate (DEHP) (measured value up to 28.6% by weight). This phthalate may harm the health of children, causing possible damage to the reproductive system. The product does not…
EU Safety Gate · reported by PolandOfficial notice → - PLEU
Plastic ball (Tasso) · Pilka
The toy contains an excessive amount of diisobutyl phthalate (DIBP) (measured value up to 18.5%). This phthalate may harm the health of children, causing possible damage to their reproductive system. The product does…
- HUEU
Night light (LE ROYAL) · lámpák
The light source can be unscrewed without removing the luminaire from the mains socket. As a result, live parts are accessible and the user could receive an electric shock from them. The product does not comply with…
- DEEU
Bolt cutter (Work Plus) · Bolzenschneider
The product contains an excessive amount of polycyclic aromatic hydrocarbons (PAHs) (measured total value: 121 mg/kg).PAHs may cause cancer and are also mutagenic and toxic for reproduction. The product does not comply…
- HUEU
USB charger (S&W) · USB Travel charger
The insulation of the product is inadequate. The user could touch accessible live parts and receive an electric shock. The product does not comply with the requirements of the Low Voltage Directive nor with the…
- HUEU
Lighting chain (CMI) · Chain of mini fairy lights
Live parts can become accessible when the lamps are being replaced or if they break. The user could touch accessible live parts and receive an electric shock. The product does not comply with the requirements of the…
- HREU
Baby swing (FOPPAPEDRETTI) · CARILLON TEDDY
The locking mechanism may disengage too easily.As a result, the child can fall from the baby swing and suffer injuries. The product does not comply with the requirements of the General Product Safety Directive nor with…
FIEUWood planer and thicknesser (Nova) · Planer/thicknesser
The basic insulation (not protected against dirt) is inadequate and the clearance/creepage distances between live parts (micro switch connector) and earthed metal part (frame) is not sufficient. Accessible parts can…
- IEEU
Smart watch (Fitbit LLC) · Fitbit Ionic Smartwatch
The battery can overheat, posing a risk of burns to the users. The product does not comply with the requirements of the Radio Equipment Directive nor with the European Standard EN 60950-1.
Collected automatically from official sources. Check each official notice for exact models, batch codes and remedies. Disclaimer