Recall roundup: 4 Oct – 10 Oct 2021
134 official recalls and safety alerts were published in the week of 4 Oct – 10 Oct 2021. Most were drugs & medical (55) and vehicles (21); common issues included food allergen (9), baby product (5), airbag (3). 35 were flagged as serious.
Recalls this week
4 Oct – 10 Oct 2021
By country
By product type
- Drugs & medical55
- Vehicles21
- Food & drink17
- Toys & kids12
- Electrical11
- Other8
Most recalled brands
Common searches
Most serious
Recalls the agency classed as serious, or with a risk of death, fire, electric shock, drowning or strangulation.
- 2021-10-08
USForest River, Inc.: Wastewater Holding Tank Missing Ventilation Pipe
In the presence of an ignition source, a gas build up increases the risk of fire.
FR
EUPassenger car (Porsche) · Macan (S. GTS. Turbo)
Adverse tolerances combined with external force may cause the lower section of the maintenance bonnet to come into contact with the fuel inlet connector on the fuel delivery unit flange. As a result, damage to the fuel…
HUEULighting chain · LED 100 BOMBILLAS / beltéri LED karácsonyi égősor
The cable is not properly anchored and is too thin; it could overheat, leading to a risk of fire or burns. The accessible wires have inadequate insulation. The user could touch accessible live parts, which may cause an…
EU Safety Gate · reported by HungaryOfficial notice →
FIEUElectronic controlgear for LED module (eurolite) · Electronic transformer 24V 8,3A
The electrical insulation is inadequate and the clearance /creepage distances between the primary and accessible secondary circuits as well as between the live circuit and the earthing circuit on the PCB are not…
- HUEU
Extension cord (ICON) · LENGÖHOSSZABITÓ
The cable inside the mains power cord is too thin. When the cable extension kit is used with class I devices, the user might suffer burns or an electric shock. The product does not comply with the requirements of the…
CA
AUTrilogy Evo O2 and Trilogy Evo Portable Ventilators
1. Infant/Pediatric EFS Calibration Pressure Increase Potential for inappropriate therapy to be provided when the EFS is used with manual calibration, increasing the risk of serious health complications including: -…
- AU
General Motors Chevrolet (GMC) Chevrolet Silverado Gen 2 GMT900 Utility Vehicle MY2014
In the event that a defective airbag inflator ruptures, metal fragments may propel out through the airbag cushion towards the vehicle occupants causing serious injury or fatality.
- 2021-10-07
- US
Tiffin Motorhomes, Inc.: Electrical Wire Not Connected
An open electrical wire can increase the risk of a fire.
- 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.
United States 73
- 2021-10-09
- US
Foretravel, Inc.: Window Adhesive Failure
Adhesive failure may cause the vent portion of the window to detach, increasing the risk of a crash or injury.
- 2021-10-08
- US
Forest River, Inc.: Emergency Exit Window Labels Incorrect/FMVSS 217
In an emergency, the incorrect window label instructions may prevent or delay the use of the emergency exit, increasing the risk of injury.
- US
Forest River, Inc.: Emergency Exit Window Labels Incorrect/FMVSS 217
In an emergency, the incorrect window label instructions may prevent or delay the use of the emergency exit, increasing the risk of injury.
- US
Forest River, Inc.: Brake Lines May Wear
Brake line failure can result in a loss of braking ability, increasing the risk of a crash.
- US
Forest River, Inc.: Wastewater Holding Tank Missing Ventilation Pipe
In the presence of an ignition source, a gas build up increases the risk of fire.
- 2021-10-07
- US
Tiffin Motorhomes, Inc.: Electrical Wire Not Connected
An open electrical wire can increase the risk of a fire.
- 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
Joovy Recalls Zoom 360 Ultralight Jogging Strollers Due to Fall Hazard (Recall Alert)
The stroller's front wheel bearing can fail or detach, posing a fall and injury hazard.
- 2021-10-06
- US
Volvo Trucks North America: Transmission May Shift to Neutral Unexpectedly
An unexpected shift to neutral can increase the risk of a crash.
- US
Nexus RVs, LLC: Stove Saddle Valves May Leak Gas
A gas leak can increase the risk of a fire.
- US
Daimler Vans USA, LLC: Starter-Generator Wiring Harness May Short
An electrical short can increase the risk of a fire.
- US
Blue Bird Body Company: Brake Line Retaining Clamp May Not Be Installed
Loss of braking ability increases the risk of a crash.
- US
Aluma KLM: Angle Mounting Bracket May Loosen
A loose angle mounting bracket may disengage, and cause the trailer bed to tilt unexpectedly, increasing the risk of a crash.
- US
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term…
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
- US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34,…
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs…
FDA · DeviceDatascope Corp.Nationwide domestic distribution. Foreign distribution worldwide.Official notice → - US
ConvaTec, Inc recalls DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Primary packaging labeling may be incorrect.
FDA · DeviceConvaTec, IncDistribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC.…Official notice → - US
Corin Ltd recalls Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size…
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
FDA · DeviceCorin LtdUS Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT,…Official notice → - US
Beckman Coulter Inc. recalls DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped…
FDA · DeviceBeckman Coulter Inc.US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH,…Official notice → - US
Hill-Rom, Inc. recalls LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The…
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may…
FDA · DeviceHill-Rom, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
GE Healthcare, LLC recalls Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3)…
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of…
FDA · DeviceGE Healthcare, LLCDistribution was nationwide, including PR. Foreign distribution was made to…Official notice → - US
Shanghai United Imaging Healthcare Co., Ltd. recalls uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in…
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.Official notice → - US
Atrium Medical Corporation recalls Atrium Pneumostat Chest Drain Valve, Part Number 16100
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
FDA · DeviceAtrium Medical CorporationDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - US
Elekta, Inc. recalls MOSAIQ Oncology Information System
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
FDA · DeviceElekta, Inc.Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH,…Official notice → - US
GE Healthcare, LLC recalls AMX Navigate Mobile X-Ray System
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
- US
Atrium Medical Corporation recalls Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular…
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide distribution in the state of Florida…Official notice → - US
ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalls Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo…
The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.
FDA · DeviceARJOHUNTLEIGH POLSKA Sp. z.o.o.US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA,…Official notice → - US
Vero Biotech, LLC recalls GENOSYL DS (Delivery System) console, for use as a vasodilator.
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
- US
Deerfield Imaging, Inc. recalls Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to…
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
FDA · DeviceDeerfield Imaging, Inc.Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR,…Official notice → - US
North Coast Medical Inc recalls EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe…
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…
FDA · DeviceNorth Coast Medical IncWorldwide distribution. US nationwide, Canada, Israel, South Africa,…Official notice → - US
Biodex Medical Systems, Inc. recalls Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an…
FDA · DeviceBiodex Medical Systems, Inc.Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia…Official notice → - US
Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of FL, MI, NY, TX, WI.Official notice → - US
IMPERATIVE CARE INC recalls Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx…
There is a potential for distal end of catheters to fracture and become detached.
- US
Abbott Molecular, Inc. recalls Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/…
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
Medline Industries Inc recalls NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only,…
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
FDA · DeviceMedline Industries IncWorldwide distribution - US Nationwide distribution and the countries of…Official notice → - US
Olympus Corporation of the Americas recalls BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
FDA · DeviceOlympus Corporation of the AmericasDomestic distribution nationwide. Product also distributed globally.Official notice → - US
Elekta Inc recalls Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
FDA · DeviceElekta IncWorldwide distribution - US Nationwide distribution in the states of PA, MI,…Official notice → - US
Lymol Medical Corporation recalls LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103,…
Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the…
- US
WOM World of Medicine AG recalls Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement…
- US
B. Braun Medical, Inc. recalls PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
FDA · DeviceB. Braun Medical, Inc.Worldwide distribution - US Nationwide distribution and the country of Canada.Official notice → - US
Vascutek, Ltd. recalls The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave…
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
- US
Accelerated Care Plus Corporation recalls Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound…
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…
- US
Deroyal Industries, Inc. Lafollette recalls DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.
FDA · DeviceDeroyal Industries, Inc. LafolletteUS distribution in Florida and South Carolina.Official notice → - US
Greiner Bio-One North America, Inc. recalls VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Blood collection tubes may experience a clotting issue.
FDA · DeviceGreiner Bio-One North America, Inc.Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA,…Official notice → - US
- US
Medina Baking and Powder Products, Inc. recalls Vanilla Flavor Imitation (White), Net Contents 128 FL. OZS. (1 Gallon)
Undeclared Egg, Yellow #5, Red #40, and Blue #1.
- US
Modern Distributors, Inc. dba Modern Vending recalls Grab & Go Bistro Pimento Cheese Sandwich 5oz plastic container 1 sandwich per package
Fish not declared as an allergen
FDA · FoodModern Distributors, Inc. dba Modern VendingDistributed to firm owned vending machines within KentuckyOfficial notice → - US
De Wafelbakkers, LLC recalls De Wafelbakkers 18 ct Buttermilk Pancakes NET WT 1 lb. 8.7 oz. (703g) KEEP FROZEN packaged in clear flexible plastic UPC 679844104573
Potential to contain Listeria monocytogenes
- US
Borinquen Cones of Puerto Rico, Inc. recalls Crunchy Cones, Chocolate, 12, NET WT 40oz (113g)
Undeclared sulfites in product label.
- US
Mckee Foods Corporation recalls Little Debbie Mini Nutty Buddy Cookie Bites Sandwich Cookies 2.5oz plastic packaging 72 pouches per case
Undeclared tree nut allergen
FDA · FoodMckee Foods CorporationDistributed through retail stores in: KY, NC, SC, TNOfficial notice → - US
SEVIROLI FOODSVERTULLO IMPORTS recalls HEB Jumbo Stuffed Shells; Jumbo Shells Filled with Creamy Ricotta and Romano Cheese; NET WT. 22 OZ (1 LB 6OZ) 624g
Product may contain foreign objects (metal).
- US
Monarch PCM, LLC recalls Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle
Stability is out of spec at 81% for 3 month time period.
- US
The Enrico Biscotti Company recalls Enrico Biscotti - Cranberry Pistachio Biscotti 8 ounce bags 6 bags per case
Undeclared soy
FDA · FoodThe Enrico Biscotti CompanyDistributed to distributors in Ohio and New York.Official notice → - US
- US
Central Kitchen Food Hub recalls Dairy Free Co. Dollup Lama Sour & Creamy Cashew Topping 4oz, 6 containers per case
Quality Concerns on off taste
- US
KEURIG DR PEPPER recalls Rc Cola 12 Oz (355 mL) packaged in an aluminum can 12 can to a pack
Consumer complaints of off flavor and aroma
FDA · FoodKEURIG DR PEPPERWest Virginia, Virginia, Ohio, Kentucky, Indiana, Pennsylvania, New Jersey,…Official notice → - US
Driscoll's Inc. recalls Driscoll's Only the Finest Berries - Blueberries/ Bluets 6 oz. and 1 pt. plastic clamshell containers. Product of Peru
Potential foreign object; metal pellets.
- US
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy recalls Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy…
Lack of Assurance of Sterility
FDA · DrugNew Vitalis Pharmacy LLC dba New Vitalis PharmacyNationwide within the United StatesOfficial notice → - US
SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in…
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
- US
- US
Washington Homeopathic Products, Inc. recalls Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium Cepa 7x Euphrasia Officinalis 7X Sabadilla…
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- US
Fresenius Kabi USA LLC recalls Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25…
Defective container: Cracked vials leading to lack of sterility assurance
- US
Monarch PCM, LLC recalls Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN…
Finished product specification did not meet USP specifications.
- US
American Health Packaging recalls Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American…
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- US
New Vision Pharmaceuticals LLC recalls CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06…
Subpotent Drug
FDA · DrugNew Vision Pharmaceuticals LLCAL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VAOfficial notice → - US
- US
Johnson & Johnson Consumer, Inc. recalls Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%),…
Chemical Contamination: presence of benzene
- US
- US
Jacobus Pharmaceutical Company Inc. recalls Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical…
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
FDA · DrugJacobus Pharmaceutical Company Inc.Product was distributed within the USA and Canada. Control # 18038, was…Official notice → - US
Hobby Lobby Recalls White Wood Stools Due to Fall and Injury Hazards
The stools can break during use, posing fall and injury hazards.
- US
ElliptiGO Recalls Arc Model Stand-Up Bicycles Due to Fall and Injury Hazards
The bicycle frame can break while riding, posing fall and injury hazards to the user.
- 2021-10-05
- US
Shyft Group: Rear Suspension Fasteners Not Tightened Properly
Loose or broken suspension fasteners can allow the rear-drive axle to shift out of place, increasing the risk of a crash.
- 2021-10-04
- US
Peach Cargo LLC: Spindle Nuts Improperly Tightened
Improperly tightened spindle nuts may cause excessive axle vibration and overheat the bearings, affecting vehicle control and increasing the risk of a crash.
- US
Nissan North America, Inc.: HPCM Software May Cause Loss of Drive Power
A loss of drive power increases the risk of a crash.
Canada 20
- 2021-10-09
- CA
- 2021-10-08
- CA
Deon Oyster Company Limited brand Atlantic Oysters recalled due to generic E. coli
Microbial contamination
- CA
- CA
- CA
- CA
- CA
- CA
- CA
- CA
Biomeme SARS-CoV-2 Real-Time RT-PCR Test (2021-07-22)
COVID - Medical devices
Health CanadaOfficial notice → - CA
- CA
- 2021-10-07
- CA
- 2021-10-06
- CA
- CA
- CA
- 2021-10-05
- CA
- CA
- CA
- 2021-10-04
- CA
Authorization of Sotrovimab for Injection for Use in Relation to the COVID-19 Pandemic
COVID - Product safety
Health CanadaOfficial notice →
United Kingdom 2
- 2021-10-07
UK- 2021-10-06
- UK
Morrisons recalls Morrisons Amour Classic Vanilla Ice Cream because it may contain pieces of plastic
It may contain pieces of plastic
Australia 15
- 2021-10-08
- AU
Trilogy Evo O2 and Trilogy Evo Portable Ventilators
1. Infant/Pediatric EFS Calibration Pressure Increase Potential for inappropriate therapy to be provided when the EFS is used with manual calibration, increasing the risk of serious health complications including: -…
- AU
MIC Gastrostomy Feeding Tubes - expanded recall
Consumers who have been supplied the products without the Instructions For Use may not be aware of important information about the use of the product. This poses an increased risk of adverse health complications.
- AU
General Motors Chevrolet (GMC) Chevrolet Silverado Gen 2 GMT900 Utility Vehicle MY2014
In the event that a defective airbag inflator ruptures, metal fragments may propel out through the airbag cushion towards the vehicle occupants causing serious injury or fatality.
- 2021-10-07
- AU
Philips M5072A Infant/Child SMART Pads Cartridge - External Defibrillator Electrode
In an emergency, if the use and/or placement of the pads is not clear to the user, there may be a delay in administering the defibrillation shock and this may increase the risk of injury to the patient.
- AU
SureClose® READYFIT™ 180° Gate Hinge-Closer Kits
If the gate hinge does not operate correctly and gates remained unlatched, it may not prevent unsupervised access to areas including pools and spas, posing a potential drowning risk.
- 2021-10-06
- AU
AVE TRI-5 LED RGB Par Can Light
Risk of electric shock, which can cause serious injury or death.
- AU
AVE QUADPRO-FLAT LED RGBW Par Can Light
Risk of electric shock, which can cause serious injury or death.
- AU
AVE HEX-FLAT6 RGBAW+UV (6-in-1) LED Par Can Light
Risk of electric shock, which can cause serious injury or death.
- AU
AVE HEX-FLAT18 Hex-Colour 18x 12W RGBAW + UV (6-in-1) LED Par Can Light
Risk of electric shock, which can cause serious injury or death.
- AU
AVE PAR64-TRI18 LED RGB Par Can Light
Risk of electric shock, which can cause serious injury or death.
- AU
AVE QUAD-FLAT LED RGBW Par Can Light
Risk of electric shock, which can cause serious injury or death.
- AU
AVE LED-PAR64B LED RGB Par Can Light
Risk of electric shock, which can cause serious injury or death.
- AU
AVE Cobra Beam 100 10W RGBW LED Beam Moving Head Light
Risk of electric shock, which can cause serious injury or death.
- AU
AVE Cobra Wash 100 LED Moving Head Wash Light
Risk of electric shock, which can cause serious injury or death.
- 2021-10-04
- AU
Ruzurgi Amifampridine 10 mg Tablet Bottle
The effects of increased exposure to yeast and/or mould can include allergic reactions, asthma, neurotoxicity, sinusitis, otomycosis, onychomycosis, keratitis, respiratory infections, skin infections, and systemic…
New Zealand 1
- 2021-10-07
NZBuckyballs Magnetic Toy
If one or more magnets are swallowed they can result in internal injuries that require surgery and pose lifelong health complications.
Product Safety NZOfficial notice →
EU & EEA 23
- 2021-10-08
EEEUParticle filter mask (mezorizon) · KN95 Protective Mask
The product bears a CE marking but its filtering capacity has not been tested by a relevant competent European conformity assessment body. Consequently, it is not proven that the product fulfils the health and safety…
IEEUMirror (Next) · Oakley Mirror
Due to insufficient glue attaching the glass mirror to the backing, the mirror may fall off and break, resulting in glass shards which can cause cuts. The product does not comply with the requirements of the General…
ESEUNecklace (Vancrystals) · Arais Rosado necklace with Swarovski crystals
The product releases an excessive quantity of nickel (measured values: up to 86 µg/cm²/week) and contains an excessive amount of lead (measured value: up to 65% by weight). Nickel is a strong sensitiser and can cause…
PLEUPlastic doll · Ballet Twinkle Toes
The toy contains bis (2-ethylhexyl) phthalate (DEHP) (measured value up to 19.4% 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
Toy slime · Slime M
The migration of boron from the toy slime is too high (measured value up to 2273.18 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging the reproductive system.…
EU Safety Gate · reported by PolandOfficial notice → - PLEU
Toy slime · Masa galaktyczna w beczce
The migration of boron from the toy slime is too high (measured value up to 721.08 mg/kg). Ingestion or contact with an excessive quantity of boron may harm the health of children by damaging the reproductive system.…
EU Safety Gate · reported by PolandOfficial notice → 
CZEUPlastic doll · FASHION
The plastic material of the head of the doll contains di-(2-ethylhexyl) phthalate (DEHP) (measured value up to 38.3% by weight).This phthalate may harm the health of children, causing possible damage to the…
EU Safety Gate · reported by CzechiaOfficial notice →
ATEUBaby stroller (Jimmylee) · Sporty
The handlebar is not resistant enough and may break causing a loss of control of the stroller. As a consequence, there could be an accident causing injuries. The product does not comply with the General Product Safety…
- FREU
Passenger car (Porsche) · Macan (S. GTS. Turbo)
Adverse tolerances combined with external force may cause the lower section of the maintenance bonnet to come into contact with the fuel inlet connector on the fuel delivery unit flange. As a result, damage to the fuel…
- FREU
Passenger transport vehicle (Kia) · Soul EV (SK3) Niro EV (DE)
The open circuit of the bus bar generating a vehicle malfunction producing a DTC. The bus bar is the large socket which is fixed by screws on the injection computer (ECU) the loose plug can lead to injection faults,…
- FREU
Passenger car (Bmw) · 3
The NADI (non-azide driver inflator) type airbag may have improper sealing that could allow moisture to enter into the propellant. If the propellant afterwards dries out, it could lead to decreased density resulting in…
DEEUBracelets (Tedi) · Armband 3 Stück
The product contains an excessive amount of cadmium (82.5% by weight). Cadmium is harmful to health. It accumulates in the body and can damage the kidneys and bones and may be carcinogenic. The product does not comply…
- HUEU
Lighting chain · LED 100 BOMBILLAS / beltéri LED karácsonyi égősor
The cable is not properly anchored and is too thin; it could overheat, leading to a risk of fire or burns. The accessible wires have inadequate insulation. The user could touch accessible live parts, which may cause an…
EU Safety Gate · reported by HungaryOfficial notice → - FIEU
Electronic controlgear for LED module (eurolite) · Electronic transformer 24V 8,3A
The electrical insulation is inadequate and the clearance /creepage distances between the primary and accessible secondary circuits as well as between the live circuit and the earthing circuit on the PCB are not…
LTEUParticle filter mask (Gram) · Protective face masks GRAM KN95 (5 layers, 1 pc.)
The particle/filter retention of the material is insufficient (measured values: as low as 28%) and the total filtration capacity of the mask is insufficient (measured mean values: as low as 64%). Consequently, the…
- LTEU
Folding stool
The stool has no locking device and the user can consequently suffer injuries with the clamping points. The product does not comply with the requirements of the General Product Safety Directive nor with the European…
EU Safety Gate · reported by LithuaniaOfficial notice → 
BGEUPassenger car (Toyota) · Prius, Prius PHEV
Due to incorrect programming, the electronic control unit (ECU) of the hybrid vehicle may incorrectly determine the position of the transmission selector lever which could cause the hybrid system to shut down.This…
- DEEU
Vehicle component - seat (Braun-Ability) · Turny Evo Bis
The seat support brace may be defective and could fail.This will lead to increased risk of injury in the event of an accident
- IEEU
Crystal Creations Hair Accessories (Crystal Creations)
Due to inadequate warning on the packaging and inadequate instructions on how to use the glue applicator, glue might come in contact with the user’s eye, causing eye injuries. The product does not comply with the CLP…
HREUSoft toy · Plush duck
The fibrous stuffing material of the toy is easily accessible due to the weakness of certain seams. A small child may put the stuffing material in the mouth and choke. The product does not comply with the requirements…
EU Safety Gate · reported by CroatiaOfficial notice →- HREU
Soft toy · PINK FONG - Soft toy
Due to the weakness of certain seams, the fibrous stuffing material of the toy is easily accessible. A child may put it in the mouth and choke. The product does not comply with the requirements of the Toy Safety…
EU Safety Gate · reported by CroatiaOfficial notice → - ESEU
Cosmetics (Mamita Botanical) · Mamita Botanical (varios productos)
This product was not manufactured according to the required good manufacturing practices and lacks the adequate evaluations before entry on the market. Furthermore, these products were lacking the adequate production…
- HUEU
Extension cord (ICON) · LENGÖHOSSZABITÓ
The cable inside the mains power cord is too thin. When the cable extension kit is used with class I devices, the user might suffer burns or an electric shock. The product does not comply with the requirements of the…
Collected automatically from official sources. Check each official notice for exact models, batch codes and remedies. Disclaimer