FoodFeb 10, 2021
Amys Kitchen Amy's Soups made with organic Lentils - Golden Lentil - Indian recall — FDA F-0243-2021
Canadian Food Inspection Agency tested product with results of 1.4 ppm of egg.
Class IIFDA: TerminatedAmys Kitchen Inc.
February 2021 recalls — page 11
These records include useful source details for the selected month.
FoodFeb 10, 2021
Champlain Chocolate Company Lake Champlain Chocolates - gift basket- BE MINE recall — FDA F-0245-2021
Chocolate may contain plastic pieces
Class IIFDA: TerminatedChamplain Chocolate Company
FoodFeb 10, 2021
Goodman Food Products Texas O Organics Plant Based Mushroom and Veggie Organic Burger recall — FDA F-0274-2021
Labeling error caused product to claim Gluten Free and Vegan when it contains wheat and dairy
Class IIFDA: TerminatedGoodman Food Products Texas Inc.
FoodFeb 10, 2021
Nongshim brand Shin Ramyun recall — FDA F-0269-2021
Small metal shavings (approximately <1 mm to 3 mm in length) were found in product.
Class IIFDA: TerminatedNongshim America, Inc.
FoodFeb 10, 2021
Champlain Chocolate Company Gift Baskets 1 recall — FDA F-0250-2021
Chocolate may contain plastic pieces
Class IIFDA: TerminatedChamplain Chocolate Company
DrugFeb 10, 2021
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL recall — FDA D-0247-2021
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugFeb 10, 2021
Nostrum Laboratories Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 recall — FDA D-0249-2021
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Class IIFDA: OngoingNostrum Laboratories Inc.
VehicleFeb 10, 2021
BMW hydraulic brakes recall — NHTSA campaign 21V062000
BMW of North America, LLC (BMW) is recalling certain 2020-2021 8 Series Coupe, Grand Coupe and convertible 840i, 840i xDrive, M850i xDrive, M8 and 740 Li, 740 Li xDrive, 750 Li xDrive, M760…
hydraulic brakesBMW of North America, LLC
Medical DeviceFeb 3, 2021
Respironics California Philips Respironics V60 Ventilator Part Number 1076717 - Product recall — FDA Z-0895-2021
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time…
Class IIFDA: TerminatedRespironics California, LLC
Medical DeviceFeb 3, 2021
Enztec REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be recall — FDA Z-0612-2020
The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in…
Class IIFDA: TerminatedEnztec Limited
Medical DeviceFeb 3, 2021
Respironics California Philips Respironics V60 Ventilator Part Number 1053617 - Product recall — FDA Z-0906-2021
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause…
Class IIFDA: OngoingRespironics California, LLC
Medical DeviceFeb 3, 2021
CRHF Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional recall — FDA Z-0926-2021
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Class IIFDA: TerminatedMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceFeb 3, 2021
Respironics California Philips Respironics V60 Ventilator Part Number 1053616 - Product recall — FDA Z-0905-2021
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause…
Class IIFDA: OngoingRespironics California, LLC
Medical DeviceFeb 3, 2021
Becton Dickinson & Company BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated recall — FDA Z-0923-2021
BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceFeb 3, 2021
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use recall — FDA Z-0918-2021
The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
Class IIFDA: TerminatedFujifilm Medical Systems U.S.A., Inc.
Medical DeviceFeb 3, 2021
Fujifilm Medical Systems U.S.A Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be recall — FDA Z-0932-2021
FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used…
Class IIIFDA: TerminatedFujifilm Medical Systems U.S.A., Inc.
Medical DeviceFeb 3, 2021
Respironics California Philips Respironics V60 Ventilator Part Number 1076709 - Product recall — FDA Z-0891-2021
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time…
Class IIFDA: TerminatedRespironics California, LLC
Medical DeviceFeb 3, 2021
Respironics California Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product recall — FDA Z-0913-2021
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause…
Class IIFDA: OngoingRespironics California, LLC
Medical DeviceFeb 3, 2021
Respironics California Philips Respironics V60 Ventilator Part Number 1053616 - Product recall — FDA Z-0888-2021
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time…
Class IIFDA: TerminatedRespironics California, LLC
Medical DeviceFeb 3, 2021
Respironics California Philips Respironics V60 Ventilator Part Number U1053617 - Product recall — FDA Z-0900-2021
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time…
Class IIFDA: TerminatedRespironics California, LLC
Medical DeviceFeb 3, 2021
OMNIlife science SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner recall — FDA Z-0921-2021
Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
Class IIFDA: TerminatedOMNIlife science Inc.
Medical DeviceFeb 3, 2021
Respironics California Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product recall — FDA Z-0898-2021
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time…
Class IIFDA: TerminatedRespironics California, LLC
Medical DeviceFeb 3, 2021
Respironics California Philips Respironics V60 Ventilator Part Number DU1053617 - Product recall — FDA Z-0916-2021
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause…
Class IIFDA: OngoingRespironics California, LLC
Medical DeviceFeb 3, 2021
Stryker Sustainability Solutions Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF recall — FDA Z-2113-2020
A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life…
Class IIFDA: TerminatedStryker Sustainability Solutions
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.