FoodJul 14, 2021
Yakult Nonfat Probiotic Drink recall — FDA F-0771-2021
Firm testing found trace levels of yeast in the product. Further investigation found the presence of Candida pelliculosa.
Class IIFDA: TerminatedYakult U.S.A. Inc.
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 64
Records are ordered by the best available source date.
DrugJul 14, 2021
Genentech Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe recall — FDA D-0650-2021
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class IIFDA: TerminatedGenentech Inc.
DrugJul 14, 2021
XYLOCAINE recall — FDA D-0651-2021
Low out of specification results for epinephrine assay.
Class IIFDA: TerminatedFresenius Kabi USA LLC
DrugJul 14, 2021
Teva Pharmaceuticals USA Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva recall — FDA D-0661-2021
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found…
Class IFDA: TerminatedTeva Pharmaceuticals USA
VehicleJul 9, 2021
Hyundai Motor hoses, lines/piping, and fittings recall — NHTSA campaign 21V524000
Hyundai Motor America (Hyundai) is recalling certain 2021-2022 Santa Fe and Sonata vehicles equipped with 2.5L turbocharged engines. Fuel may leak at the pipe connection between the…
hoses, lines/piping, and fittingsHyundai Motor America
VehicleJul 8, 2021
Kia Motors hoses, lines/piping, and fittings recall — NHTSA campaign 21V519000
Kia Motor America (Kia) is recalling certain 2021 Sorento and 2021-2022 K5 vehicles equipped with 2.5L turbocharged engines. Fuel may leak at the pipe connection between the high-pressure…
hoses, lines/piping, and fittingsKia Motors America
VehicleJul 8, 2021
BMW frontal air bag recall — NHTSA campaign 21V520000
BMW of North America, LLC (BMW) is recalling one 2019 X5 xDrive 40i vehicle. The instrument panel may not have been manufactured correctly, which could prevent the passenger side air bag…
frontal air bagBMW of North America, LLC
VehicleJul 8, 2021
BMW frontal air bag recall — NHTSA campaign 21V521000
BMW of North America, LLC (BMW) is recalling certain 2018-2019 X3 sDrive30i, X3 xDrive30i, X3 M40i and 2019 X4 xDrive30i, and X4 M40i vehicles. The front passenger seat occupant…
frontal air bagBMW of North America, LLC
Medical DeviceJul 7, 2021
Flowonix Medical Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used recall — FDA Z-1996-2021
Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be…
Class IIFDA: TerminatedFlowonix Medical Inc.
Medical DeviceJul 7, 2021
Smiths Medical ASD PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 recall — FDA Z-1993-2021
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceJul 7, 2021
CAREFUSION MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product recall — FDA Z-1995-2021
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Class IIFDA: TerminatedCAREFUSION
Medical DeviceJul 7, 2021
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX recall — FDA Z-1959-2021
There is a potential that the pressure tubing may detach from the blood sampling system
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceJul 7, 2021
Philips Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 recall — FDA Z-1989-2021
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceJul 7, 2021
Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE recall — FDA Z-1964-2021
There is a potential that the pressure tubing may detach from the blood sampling system
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceJul 7, 2021
Exactech Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT recall — FDA Z-1977-2021
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
Class IIFDA: CompletedExactech, Inc.
Medical DeviceJul 7, 2021
Spes Medica Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2 recall — FDA Z-1969-2021
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Class IIFDA: TerminatedSpes Medica
Medical DeviceJul 7, 2021
Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set recall — FDA Z-1960-2021
There is a potential that the pressure tubing may detach from the blood sampling system
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceJul 7, 2021
Philips Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 recall — FDA Z-1990-2021
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceJul 7, 2021
Philips Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket recall — FDA Z-1983-2021
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceJul 7, 2021
SPINEART SA PERLA TL Lateral Connector Open - Product Usage: intended to be used with recall — FDA Z-1975-2021
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Class IIFDA: TerminatedSPINEART SA
Medical DeviceJul 7, 2021
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI recall — FDA Z-1966-2021
There is a potential that the pressure tubing may detach from the blood sampling system
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceJul 7, 2021
Philips Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor recall — FDA Z-1987-2021
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceJul 7, 2021
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI recall — FDA Z-1962-2021
There is a potential that the pressure tubing may detach from the blood sampling system
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceJul 7, 2021
Magellan Diagnostics LeadCare II Blood Lead Test Kit Catalog Number 70-6762 recall — FDA Z-1952-2021
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in…
Class IFDA: TerminatedMagellan Diagnostics, Inc.
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.