FoodFeb 16, 2022
Dole 13oz Southwest Kit Product UPC 071430017012 Little Salad recall — FDA F-0678-2022
Potential Listeria monocytogenes
Class IFDA: TerminatedDole Fresh Vegetables Inc.
February 2022 recalls — page 7
These records include useful source details for the selected month.
FoodFeb 16, 2022
Natural Way Cheese retail 12oz plastic bag UPC 8 10056 75022 0, 12 retail units recall — FDA F-0633-2022
The milk used in the cheese curd had been stored in a holding tank in excess of 72 hours, therefore exceeding the required 72 hour tank cleaning interval.
Class IIFDA: TerminatedNatural Way Cheese
FoodFeb 16, 2022
Natural Way Cheese retail 12oz plastic bag UPC 8 10056 75106 7, 12 retail units recall — FDA F-0634-2022
The milk used in the cheese curd had been stored in a holding tank in excess of 72 hours, therefore exceeding the required 72 hour tank cleaning interval.
Class IIFDA: TerminatedNatural Way Cheese
DrugFeb 16, 2022
Esupplementsales HARD DAWN, Rise and Shine capsules, 500 mg recall — FDA D-0561-2022
Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an…
Class IFDA: TerminatedEsupplementsales, LLC
DrugFeb 16, 2022
Junp Hydration MegMan Performance Booster, 800 mg capsules recall — FDA D-0557-2022
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making…
Class IFDA: TerminatedJunp Hydration LLC
DrugFeb 16, 2022
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials recall — FDA D-0556-2022
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class IFDA: TerminatedAuroMedics Pharma LLC
VehicleFeb 16, 2022
Mustang knee bolster recall — NHTSA campaign 22V083000
Ford Motor Company (Ford) is recalling certain 2021-2022 Mustang vehicles. An insufficient weld on the front passenger knee air bag may result in an improper air bag deployment.
knee bolsterFord Motor Company
VehicleFeb 16, 2022
Ford filler pipe and cap recall — NHTSA campaign 22V088000
Ford Motor Company (Ford) is recalling certain 2022 Explorer and Lincoln Aviator vehicles. The fuel filler tube may detach during a crash. As such, these vehicles fail to comply with the…
filler pipe and capFord Motor Company
VehicleFeb 16, 2022
Volkswagen Group of labels recall — NHTSA campaign 22V086000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2018-2021 Atlas and 2020-2021 Atlas Cross Sport vehicles equipped with accessory side steps. The reduced Gross Vehicle…
labelsVolkswagen Group of America, Inc.
Medical DeviceFeb 9, 2022
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code recall — FDA Z-0530-2022
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceFeb 9, 2022
Abiomed OXY-1 System, Model Number 001-0500-001 recall — FDA Z-0550-2022
The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy…
Class IFDA: TerminatedAbiomed, Inc.
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0534-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
Luminex ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 recall — FDA Z-0553-2022
Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due…
Class IIFDA: TerminatedLuminex Corporation
Medical DeviceFeb 9, 2022
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF recall — FDA Z-0555-2022
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
Class IIFDA: OngoingYoung Dental Mfg Co I LLC
Medical DeviceFeb 9, 2022
Immuno-Mycologics CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the recall — FDA Z-0545-2022
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number…
Class IIFDA: TerminatedImmuno-Mycologics, Inc.
Medical DeviceFeb 9, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01 recall — FDA Z-0558-2022
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European…
Class IIFDA: TerminatedCELLTRION USA Inc.
Medical DeviceFeb 9, 2022
Siemens Medical Solutions USA ACUSON Sequoia Ultrasound Imaging System with Software Version recall — FDA Z-0547-2022
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0542-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0540-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0535-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode recall — FDA Z-0536-2022
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Class IIFDA: TerminatedDIXI MEDICAL USA
Medical DeviceFeb 9, 2022
Covidien Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon recall — FDA Z-0557-2022
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the…
Class IIFDA: OngoingCovidien LLC
Medical DeviceFeb 9, 2022
Microbiologics KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P recall — FDA Z-0543-2022
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
Class IIIFDA: TerminatedMicrobiologics Inc.
Medical DeviceFeb 9, 2022
Baxter Spectrum IQ Infusion Pumps, Product code 3570009 recall — FDA Z-0529-2022
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup…
Class IFDA: OngoingBaxter Healthcare Corporation
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.