Recalls in 2021
Records start Oct 2021
By month
Most recalled brands
By product type
Recalls in the United States in 2021
- 2021-12-29
USPACCAR Incorporated: Methane Detection System May Fail
The operator may be unaware of a system malfunction or the presence of excessive methane levels, increasing the risk of injury or fire.
- US
Medtronic Navigation, Inc. recalls Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the…
A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy…
FDA · DeviceMedtronic Navigation, Inc.US: FL, NE, CA, MN, TX, OH, IL, AZ, KS, KY, OR, OK, WA, NV, MO, IN, MI, UT,…Official notice → - US
Philips North America Llc recalls Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging…
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide distribution in the states of DC, GA,…Official notice → - US
Acclarent, Inc. recalls TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy…
FDA · DeviceAcclarent, Inc.US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV,…Official notice → - US
Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced…
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
FDA · DeviceCook Inc.Worldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice → - US
Coloplast Manufacturing US, LLC recalls Torosa Saline-Filled Testicular Prosthesis (Size Small)
Product is mislabeled for size.
FDA · DeviceColoplast Manufacturing US, LLCWorldwide distribution - US Nationwide distribution and the country of Canada.Official notice → - US
Leica Microsystems, Inc. recalls Leica Microsystems M220 F12 Microscope Systems
In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some…
FDA · DeviceLeica Microsystems, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, DC,…Official notice → - US
ROi CPS LLC recalls regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
The kit contains a non-sterile needle.
FDA · DeviceROi CPS LLCDistribution was made to Missouri. There was no foreign/military/government…Official notice → - US
Beaver Visitec International, Inc. recalls Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part…
Kit packaging may have small holes compromising product sterility
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of IL, OH, MS, and PA.Official notice → - US
Maquet Cardiovascular, LLC recalls Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of IL and NC.Official notice → - US
Hill-Rom Inc. recalls These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0…
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
- US
Wright Medical Technology, Inc. recalls Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc…
Incorrect product is contained in the packaging.
FDA · DeviceWright Medical Technology, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, IA,…Official notice → - US
Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareNJ, MI, MA, NY, TX, CO, NC, CT, OR, OHOfficial notice → - US
Beckman Coulter Inc. recalls SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in…
FDA · DeviceBeckman Coulter Inc.US Nationwide distribution in the states of Louisiana, Ohio, North Carolina,…Official notice → - US
Civco Medical Instruments Co. Inc. recalls VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
FDA · DeviceCivco Medical Instruments Co. Inc.Worldwide distribution - US Nationwide and the countries of Belgium, Canada,…Official notice → - US
Cardiovascular Systems Inc recalls WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating…
FDA · DeviceCardiovascular Systems IncUnited States- AK, AL, AR, AZ, CA, DC, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA,…Official notice → - US
Wright Medical Technology Inc recalls Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
The incorrect product is contained in the packaging.
FDA · DeviceWright Medical Technology IncWorldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The…Official notice → - US
Medtronic Navigation, Inc. recalls Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model:…
Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy…
FDA · DeviceMedtronic Navigation, Inc.US: MN, FL, MD, IL, AK, NE, NH, PA, ND, AR, CA, WI, NJ, GA, SD, AZ, KY, AL,…Official notice → - US
- US
- US
Dakota Tom's, Inc recalls Dakota Tom's and Market Fresh branded Chicken Salad Croissant sandwiches. Net Wt. 6.5 oz. UPC 37296-10100, Dakota Toms, Box 271, Corsica,…
Sandwiches contain undeclared egg and milk.
- US
- US
- US
Calise & Sons Bakery, Inc. recalls Golden Flax Seed Scala Bread,
Contains undeclared sesame seeds
- US
COCA COLA Consolidated LLC recalls Coca-Cola cola; 12 oz. aluminum can; 12-pack fridge pack/case
Potential presence of foreign matter in container.
FDA · FoodCOCA COLA Consolidated LLCProduct was shipped to the following states: AR, MS, and TN,Official notice → - US
Black Rifle Coffee Company recalls Black Rifle Coffee Mac V Whole Bean Coffee 12oz PET bags 40 bags per case
Possible plastic within final product packaging.
- US
- US
- US
Efficient Laboratories, Inc. recalls Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL…
Microbial Contamination of Non-Sterile Products
- US
The Harvard Drug Group recalls Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive,…
Failed Impurities/Degradation Specifications
- US
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796…
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide within the United StatesOfficial notice → - US
Medline Industries Inc recalls Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and…
Defective Container: Customer complaints for leaking bottles and dispensing issues.
- US
Scott Fetzer Consumer Brands Recalls American Angler Electric Fillet Knives Due to Laceration Hazard
The trigger mechanism on the Electric Fillet Knife ("EFK") units can become stuck in the "on" position, posing a laceration hazard.
CPSCWeihai Yuanji Outdoor Products Co., Ltd. (RTI), of ChinaAbout 43,200 (In addition, about 630 were sold in Canada)Official notice → - 2021-12-28
- US
Hyundai Motor America: Inadequate Windshield Bonding
A windshield that detaches from a vehicle during a crash can increase the risk of injury.
- US
Hyundai Motor America: Illegible Instrument Cluster Display/FMVSS 101
An illegible instrument cluster will not show information such as vehicle speed or safety system warnings, which can increase the risk of a crash.
- 2021-12-27
- US
Mercedes-Benz USA, LLC: Disabled Emergency Call System
A disabled eCall system would prevent a vehicle occupant from contacting emergency services through the call center in an emergency, potentially delaying emergency responders and increasing the risk of injury.
- 2021-12-23
- US
Daimler Trucks North America, LLC: Damaged Circuit Board Affects Lighting Functions
Non-functioning brake lights, rear markers, or turn signals can reduce vehicle visibility to other drivers, increasing the risk of a crash.
- US
Crysteel Manufacturing Inc: Hydraulic Cylinder Failure
Cylinder detachment can contact the cab and cause a loss of control of the dump body, increasing the risk of injury or crash.
- US
Toyota Motor Engineering & Manufacturing: Power Steering Gear Assembly May Leak Oil
An oil leak may cause a sudden loss of power steering assist, increasing the risk of a crash.