FoodMay 25, 2022
T Fresh Company DBA Yes Produce Yes! Enoki Mushrooms recall — FDA F-1069-2022
California Department of Public Health sampled product with a result of Listeria monocytogenes
Class IFDA: TerminatedT Fresh Company DBA Yes Produce
May 2022 recalls — page 3
These records include useful source details for the selected month.
FoodMay 25, 2022
Driscoll's 12x12 oz, 12x10 oz, 2x8x18 oz Clamshell Distributed by recall — FDA F-1067-2022
California Department of Pesticide Regulation detected the presence of Formetante HCI. This pesticide has a non-tolerance for blackberries.
Class IIIFDA: TerminatedDriscoll's Inc.
DrugMay 25, 2022
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle recall — FDA D-0881-2022
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class IIIFDA: TerminatedApotex Corp.
DrugMay 25, 2022
Plastikon Healthcare MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup recall — FDA D-0870-2022
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class IIFDA: CompletedPlastikon Healthcare LLC
DrugMay 25, 2022
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens recall — FDA D-0882-2022
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class IFDA: CompletedCardinal Health Inc.
DrugMay 25, 2022
Plastikon Healthcare Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone recall — FDA D-0871-2022
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class IIFDA: CompletedPlastikon Healthcare LLC
DrugMay 25, 2022
Plastikon Healthcare Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup recall — FDA D-0869-2022
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class IIFDA: CompletedPlastikon Healthcare LLC
DrugMay 25, 2022
Plastikon Healthcare MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup recall — FDA D-0867-2022
Microbial Contamination of Non-Sterile Products
Class IFDA: CompletedPlastikon Healthcare LLC
DrugMay 25, 2022
Plastikon Healthcare Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone recall — FDA D-0868-2022
Microbial Contamination of Non-Sterile Products
Class IFDA: CompletedPlastikon Healthcare LLC
DrugMay 25, 2022
Bestco Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint recall — FDA D-0879-2022
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Class IIIFDA: TerminatedBestco LLC
DrugMay 25, 2022
American Health Packaging Nitrofurantoin Capsules, USP recall — FDA D-0880-2022
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class IIIFDA: TerminatedAmerican Health Packaging
VehicleMay 23, 2022
Volkswagen Group of engine control module (ecu/ecm) recall — NHTSA campaign 22V368000
Volkswagen Group of America, Inc. (Audi) is recalling certain 2022 Audi A6 Sedan, A4 Sedan, Q5, and Q5 Sportback vehicles. The semiconductor inside the engine control unit may short-circuit…
engine control module (ecu/ecm)Volkswagen Group of America, Inc.
VehicleMay 19, 2022
Hyundai Motor front recall — NHTSA campaign 22V354000
Hyundai Motor America (Hyundai) is recalling certain 2020-2022 Accent, 2021-2022 Elantra, and 2021-2022 Elantra HEV vehicles. In the event of a crash, the front driver-side and/or…
frontHyundai Motor America
VehicleMay 19, 2022
General Motors seats recall — NHTSA campaign 22V359000
General Motors, LLC (GM) is recalling certain 2021 Chevrolet Malibu, 2022 Chevrolet Equinox, Blazer and Cadillac XT4 vehicles. The driver's seat cushion frame may have an improper weld in…
seatsGeneral Motors, LLC
Medical DeviceMay 18, 2022
Daavlin Distributing Company 4 Series CX phototherapy units equipped with Daavlin's recall — FDA Z-1074-2022
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
Class IIFDA: OngoingDaavlin Distributing Company
Medical DeviceMay 18, 2022
Karl Storz Endoscopy 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016) recall — FDA Z-1068-2022
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Class IIFDA: OngoingKarl Storz Endoscopy
Medical DeviceMay 18, 2022
MESA BIOTECH Accula SARS-CoV-2 Test, REF: COV4100 recall — FDA Z-1009-2022
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Class IFDA: OngoingMESA BIOTECH, Inc.
Medical DeviceMay 18, 2022
Cerapedics putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY recall — FDA Z-1056-2022
Patient chart label contains incorrect Part Number and volume amount.
Class IIIFDA: TerminatedCerapedics, Inc.
Medical DeviceMay 18, 2022
Karl Storz Endoscopy 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD recall — FDA Z-1064-2022
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Class IIFDA: OngoingKarl Storz Endoscopy
Medical DeviceMay 18, 2022
Karl Storz Endoscopy 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US recall — FDA Z-1054-2022
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Class IIFDA: OngoingKarl Storz Endoscopy
Medical DeviceMay 18, 2022
Shanghai United Imaging Healthcare Co Digital Medical X-ray Imaging System, Model: uDR 596i recall — FDA Z-1075-2022
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the…
Class IIFDA: TerminatedShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceMay 18, 2022
Karl Storz Endoscopy 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 recall — FDA Z-1065-2022
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Class IIFDA: OngoingKarl Storz Endoscopy
Medical DeviceMay 18, 2022
USA Medical Diagnostic Kit SARS-cCo V Antigen Rapid Test recall — FDA Z-1050-2022
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
Class IIFDA: OngoingUSA Medical, LLC
Medical DeviceMay 18, 2022
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for recall — FDA Z-1042-2022
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Class IIFDA: OngoingMedtronic Vascular, Inc.
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.