Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

13351–13375 of 39988

LowFDA (Devices)·Z-0247-2022·2021-11-24
VITROS Immunodiagnostic Anti-HBc Controls Recalled Due to Incorrect Booklet Information
Ortho-Clinical Diagnostics recalled 191 units of VITROS Anti-HBc IgM Controls (Lot 1690) because the Controls Values booklet contained incorrect product information. Although patient test result accuracy is not affected, there is potential for delayed quality control troubleshooting.
Product
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-0183-2022·2021-11-17
Ellume COVID-19 Home Test Recalled for Higher Rate of False Positives
Ellume recalled approximately 427,994 COVID-19 home test kits due to a higher rate of false positive results. The affected kits were distributed in Minnesota, New York, Pennsylvania, Rhode Island, Utah, and Washington.
Product
Ellume COVID-19 Home Test
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0208-2022·2021-11-17
Safety Blood Collection Needle Recalled for Safety Mechanism Activation Issues
Zhejiang Kindly Medical Devices is recalling Henry Schein Safety Blood Collection Needles due to potential difficulty activating the safety mechanism. Affected lot numbers distributed nationwide.
Product
HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0212-2022·2021-11-17
Photopheresis Kit Recalled Due to Incomplete Testing Before Release
Therakos is recalling 15 photopheresis kits because they were released before testing was completed. If used, a drive tube leak could cause illness or injury.
Product
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0207-2022·2021-11-17
McKesson PREVENT HT Winged Blood Collection Needles Recall for Safety Mechanism Difficulty
McKesson PREVENT HT Safety Winged Blood Collection Needles may have difficulty activating their safety mechanism. The recall affects units distributed nationwide.
Product
McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0211-2022·2021-11-17
QuikClot Combat Gauze Recalled for Potential Sterile Packaging Seal Failure
Z-Medica is recalling 2400 units of QuikClot Combat Gauze due to potential packaging seal failures that could compromise sterile barrier integrity. Affected lot 12645 was distributed nationwide.
Product
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0213-2022·2021-11-17
Philips Azurion X-Ray Systems may lock up during simultaneous button presses
Philips Azurion Interventional X-Ray Systems (software 2.1.x) may experience imaging lock-up when operators simultaneously press both the APC and Float Tabletop buttons.
Product
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0210-2022·2021-11-17
Covidien Emprint Ablation Catheter temperature monitoring defect
Covidien is recalling the Emprint Ablation Catheter due to a defect in temperature monitoring circuitry. If the cooling system fails during use, the device tip could overheat, causing tissue burns, unintended ablation, and allergic reactions.
Product
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0205-2022·2021-11-17
McKesson Safety Blood Collection Needles Recalled Over Safety Mechanism Activation Risk
Nationwide recall of McKesson PREVENT HT Safety Blood Collection Needles (22G 1 1/4 inch) due to potential difficulty activating the safety mechanism. The protective feature may fail to engage properly during use.
Product
McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0204-2022·2021-11-17
McKesson Safety Blood Collection Needles Recalled for Safety Mechanism Defect
McKesson PREVENT HT Safety Blood Collection Needles are being recalled due to potential difficulty in activating the safety mechanism. The recall affects needles distributed nationwide, including specific lot numbers with expiration dates through May 2025.
Product
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0206-2022·2021-11-17
McKesson PREVENT HT Blood Collection Needle Safety Mechanism Activation Issue
McKesson PREVENT HT blood collection needles with specific lot numbers may have difficulty activating their safety mechanism. Healthcare facilities should contact the manufacturer for replacement guidance.
Product
McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0215-2022·2021-11-17
Hemodialysis Delivery System Software May Use Incorrect Treatment Parameters
Baxter's Hemodialysis Delivery System may incorrectly revert to old prescription values when operators change prescriptions after filter changes, potentially resulting in incorrect treatment parameters.
Product
Hemodialysis Delivery System, Software Version 2.x.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0209-2022·2021-11-17
Safety Blood Collection Needles Recalled Due to Safety Mechanism Activation Difficulty
Henry Schein safety blood collection needles may have difficulty activating their safety mechanism, potentially increasing needlestick injury risk. Affected lots were distributed nationwide with expiration dates through late 2025.
Product
HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0214-2022·2021-11-17
T4 EIA Diagnostic Kit Recall Due to Shelf-Life Quality Standards Failure
BioCheck, Inc. is recalling 314 T4 EIA Kit units due to failed shelf-life standards that resulted in failed quality control tests. The kits were distributed to five U.S. states and three overseas countries.
Product
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0119-2022·2021-11-10
Monoject Prefilled Syringe Plunger Defect Recall: Air Reintroduction Risk
Monoject prefilled syringes in medical kits may have a plunger that rebounds after air expulsion, potentially reintroducing air into the syringe. This FDA Class I recall affects approximately 9,378 units distributed in Florida and Pennsylvania.
Product
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack…
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0194-2022·2021-11-10
IPL Coupling Gel and EcoGel 200 Recalled for Bacterial Contamination
Lumenis, Inc. is recalling IPL Coupling Gel and EcoGel 200 due to potential bacterial contamination. Approximately 11,064 units were distributed worldwide.
Product
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2022·2021-11-10
Lisendo 880 Ultrasound Software displays incorrect cardiac valve measurements
Lisendo 880 Ultrasound Software versions V1.0–V4.1.3 may not display cardiac measurement results correctly for mitral valve assessments, affecting diagnostic accuracy.
Product
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0195-2022·2021-11-10
Siemens COVID-19 Diagnostic Assay Recalled for Inadequate Validation Data
Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.
Product
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0186-2022·2021-11-10
Flexor Check-Flo Introducer Sets recalled due to misplaced radiopaque marker band
Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.
Product
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0187-2022·2021-11-10
COVENA PICC Sleeve Recalled for Unauthorized FDA Marketing
Queen Comfort Products is recalling the COVENA PICC Sleeve, marketed without FDA clearance. Patients currently using the device should contact their healthcare provider immediately.
Product
COVENA PICC Sleeve
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2022·2021-11-10
Artis zeego X-Ray System Software Error Affects Image Reconstruction
Siemens Artis zeego fluoroscopic X-ray systems have a software error that incorrectly displays 3D image reconstruction when the patient table is rotated more than 4 degrees, potentially resulting in incorrect patient treatment during image-guided procedures.
Product
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2022·2021-11-10
Arietta 850 Ultrasound Software Displays Cardiology Measurements Incorrectly
FujiFilm Arietta 850 ultrasound systems with affected software versions display cardiology measurement results incorrectly. The recall affects 38 units distributed nationwide.
Product
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0189-2022·2021-11-10
Arietta 750 Ultrasound Software Versions Affected by Incorrect Measurement Display
FujiFilm Healthcare is recalling Arietta 750 Ultrasound Software versions V1.0.0 through V2.1.3 due to measurement display errors in critical cardiology functions that could lead to incorrect clinical diagnoses. The instruction manual also contains an error.
Product
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2022·2021-11-10
Arietta 65 Ultrasound Software: Calculation Error in EROA Diagnostic Measurements
Arietta 65 Ultrasound systems with software versions 1.0 through 4.0.0 contain a calculation error that produces incorrect measurements of cardiac valve function during diagnostic assessments.
Product
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0184-2022·2021-11-10
Flexible Intubation Videoscope Recall Due to Sterility Assurance Failure
Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.
Product
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Category
Medical Device
Distribution
40 states

How to read this listing

Filters

13351–13375 of 39988