FoodDec 29, 2021
GIVE AND GO two-bite vanilla & chocolate cupcakes 10 oz recall — FDA F-0290-2022
Potential for metal in product
Class IIFDA: TerminatedGIVE AND GO
Monthly breakdown
2021 recalls by month
Select a month to review the recall records reported during that period.
December 2021194 records · 4 categoriesNovember 2021210 records · 4 categoriesOctober 2021342 records · 4 categoriesSeptember 2021300 records · 4 categoriesAugust 2021279 records · 4 categoriesJuly 2021251 records · 4 categoriesJune 2021361 records · 4 categoriesMay 2021226 records · 4 categoriesApril 2021279 records · 4 categoriesMarch 2021241 records · 4 categoriesFebruary 2021320 records · 4 categoriesJanuary 2021226 records · 4 categories
2021 recalls — page 2
Records are ordered by the best available source date.
DrugDec 29, 2021
Rompe Pecho Ex Expectorant recall — FDA D-0292-2022
Microbial Contamination of Non-Sterile Products
Class IIFDA: TerminatedEfficient Laboratories, Inc.
DrugDec 29, 2021
Denver Solutions, LLC DBA Leiters Health Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution recall — FDA D-0288-2022
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Class IIFDA: TerminatedDenver Solutions, LLC DBA Leiters Health
DrugDec 29, 2021
Medline Industries Hand Sanitizer Foam (ethyl alcohol), 62% v/v recall — FDA D-0287-2022
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Class IIFDA: TerminatedMedline Industries Inc.
DrugDec 29, 2021
Teva Pharmaceuticals USA Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) recall — FDA D-0294-2022
Subpotent
Class IIFDA: TerminatedTeva Pharmaceuticals USA
VehicleDec 28, 2021
Hyundai Motor windshield recall — NHTSA campaign 21V00M000
Hyundai Motor America (Hyundai) is recalling certain 2020-2021 Santa Fe, 2021 Sonata, and Elantra vehicles. During manufacturing, the windshield may not have been properly bonded to the…
windshieldHyundai Motor America
VehicleDec 23, 2021
Toyota Motor Engineering & Manufacturing hydraulic power assist system recall — NHTSA campaign 21E103000
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain JTEKT power steering gear assembly service parts for 2007-2021 Tundra and 2008-2022 Sequoia, part numbers 44250-0C160,…
hydraulic power assist systemToyota Motor Engineering & Manufacturing
Medical DeviceDec 22, 2021
Cardinal Health SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long recall — FDA Z-0368-2022
Potential for open packaging seals compromising the sterility of the surgical gowns
Class IIFDA: OngoingCardinal Health
Medical DeviceDec 22, 2021
Activbody activforce 2 package labeling: Model: Activ5-M R 201-200563 recall — FDA Z-0386-2022
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its…
Class IIFDA: OngoingActivbody, Inc.
Medical DeviceDec 22, 2021
Cook Flexor Check-Flo Introducer Ansel Modification recall — FDA Z-0387-2022
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Class IIFDA: TerminatedCook Inc.
Medical DeviceDec 22, 2021
CRHF Medical Device Identification Cards associated with Astra XT DR Implantable pulse recall — FDA Z-0391-2022
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system…
Class IIFDA: TerminatedMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceDec 22, 2021
Ossur Americas Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item recall — FDA Z-0380-2022
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Class IIFDA: TerminatedOssur Americas
Medical DeviceDec 22, 2021
Datascope Cardiosave Hybrid IntraAortic Balloon Pump recall — FDA Z-0336-2022
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could…
Class IFDA: OngoingDatascope Corp.
Medical DeviceDec 22, 2021
Smith & Nephew smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 recall — FDA Z-0364-2022
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released…
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceDec 22, 2021
Smith & Nephew smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF recall — FDA Z-0366-2022
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released…
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceDec 22, 2021
Xstrahl Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy recall — FDA Z-0389-2022
Base plate may detach from the main body of the treatment applicator.
Class IIFDA: TerminatedXstrahl Limited
Medical DeviceDec 22, 2021
Smith & Nephew smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF recall — FDA Z-0365-2022
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released…
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceDec 22, 2021
Datascope Cardiosave Rescue IntraAortic Balloon Pump recall — FDA Z-0337-2022
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could…
Class IFDA: OngoingDatascope Corp.
Medical DeviceDec 22, 2021
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized recall — FDA Z-0367-2022
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Class IIFDA: OngoingMentor Texas, LP.
Medical DeviceDec 22, 2021
Cardinal Health SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long recall — FDA Z-0371-2022
Potential for open packaging seals compromising the sterility of the surgical gowns
Class IIFDA: OngoingCardinal Health
Medical DeviceDec 22, 2021
Cook Flexor Check-Flo Introducer Ansel Modification recall — FDA Z-0388-2022
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Class IIFDA: TerminatedCook Inc.
Medical DeviceDec 22, 2021
Smith & Nephew smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 recall — FDA Z-0363-2022
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released…
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceDec 22, 2021
CRHF Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN recall — FDA Z-0390-2022
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system…
Class IIFDA: TerminatedMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceDec 22, 2021
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 recall — FDA Z-0381-2022
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Class IIFDA: TerminatedBoston Scientific Corporation
About the 2021 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.