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

13176–13200 of 40112

ModerateFDA (Devices)·Z-0482-2022·2022-01-19
Instavac Portable Suction Pumps Recalled for Premature Device Failures
Ohio Medical Corporation is recalling Instavac Portable Suction Pumps (models 757000, 756000, and replacement pump part #AI5511) due to an increase in premature device failures. Affected units were distributed nationwide.
Product
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0467-2022·2022-01-19
Ki Mobility Little Wave Tyke Manual Contains Incorrect Instructions
The Instructions for Use provided with Ki Mobility Little Wave Tyke contained instructions for a mechanical wheelchair instead of the caster-based design. Following incorrect instructions could lead to improper device operation.
Product
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0455-2022·2022-01-12
COVID-19 Diagnostic Kit Recall for Inaccurate Test Results
Qiagen Sciences is recalling 376 units of its QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kit due to faulty cartridges that can produce false-negative or false-positive test results.
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0445-2022·2022-01-12
Power wheelchairs with LiNX Gyro module recalled for deceleration control failure
Invacare power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, risking user injury due to an incorrect deceleration profile.
Product
Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0457-2022·2022-01-12
Medical Device Kit Poses Risk of Sample Leakage and Lab Contamination
DiaSorin Molecular's Simplexa Direct Amplification Disc Kit is recalled due to risk of leakage when used multiple times, which may cause cross-contamination in laboratory settings if not properly cleaned.
Product
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-0462-2022·2022-01-12
Alinity m System recalled for software defect in amplification detection
Abbott Molecular is recalling 742 Alinity m Systems worldwide due to a software defect that can set the Amplification Detection clamp CLEAN position too high, potentially affecting instrument operation.
Product
Alinity m System, Part No. 08N53-002
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0463-2022·2022-01-12
Abbott Alinity m System camera firmware installation issue
Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.
Product
Alinity m System, Part No. 08N53-002
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0453-2022·2022-01-12
Medshape DYNANAIL MINI surgical nail recalled for improper endcap length
Medshape is recalling DYNANAIL MINI surgical nails due to manufacturing defect in lot 04882. Affected endcaps may not seat flush during surgical insertion, potentially affecting implant integrity.
Product
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0461-2022·2022-01-12
Alinity m System Software Issue Affects Maintenance and Diagnostics Procedures
Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.
Product
Alinity m System, Part No. 08N53-002
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0449-2022·2022-01-12
Clinical Chemistry Analyzer Software Flaw May Cause Inaccurate Test Results
Siemens is recalling Atellica CH 930 clinical chemistry analyzers with software v1.25.1 or lower. Two software defects could cause inaccurate test results: test parameters may revert to defaults, or the analyzer may use expired reagents.
Product
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0446-2022·2022-01-12
Invacare AVIVA FX power wheelchair LiNX Gyro deceleration malfunction
Some Invacare AVIVA FX power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, creating injury risk.
Product
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0458-2022·2022-01-12
UROMEDICA Implantation Instrument Sheath May Damage ProACT Implants
Uromedica is recalling nonsterile implantation instrument sheaths (Lot UM00794 and UM00817) because the U-channel sheaths may damage ProACT implant devices during implantation procedures. Affected devices were distributed nationwide.
Product
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0448-2022·2022-01-12
Orthopedic Inserter Shaft Recalled for Mating Incompatibility During Surgery
Flower Orthopedics is recalling 48 units of the Flex-Thread Inserter Shaft due to mating incompatibility with the Inserter Draw Rod. The defect may cause the draw rod to bind during fibula intramedullary nail insertion, potentially preventing surgery completion.
Product
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0459-2022·2022-01-12
Surgical Instrument Tray Recalled for Incorrect Keel Punch Component
Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Trays that may contain the wrong surgical instrument. The incorrect component could delay surgery or cause unintended bone preparation during knee replacement procedures.
Product
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0460-2022·2022-01-12
Abbott Alinity m System Molecular Diagnostic Device Amplification Defect Recall
Abbott Molecular is recalling 742 Alinity m System diagnostic devices worldwide due to potential for abnormal amplification curves that could affect test accuracy.
Product
Alinity m System, Part No. 08N53-002
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0464-2022·2022-01-12
Medtronic Abre Venous Stent System recalled for reports of stent migration
Medtronic is recalling the Abre Venous Self-Expanding Stent System due to reports of stent migration. Approximately 21,653 devices were distributed nationwide and internationally.
Product
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0456-2022·2022-01-12
Hemodialysis Delivery System distributed without FDA premarket approval
The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.
Product
DBB-06 Hemodialysis Delivery System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0447-2022·2022-01-12
Invacare AVIVA Storm RX Power Wheelchairs Recalled for Firmware Deceleration Malfunction
Invacare AVIVA Storm RX power wheelchairs with firmware version 6.1.2 may decelerate more aggressively than programmed, risking user injury.
Product
Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0452-2022·2022-01-12
Biomeme SARS-CoV-2 Test Instructions Recall: Incorrect Buffer Shelf-Life
Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.
Product
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0454-2022·2022-01-12
iontoPATCH On-the-Go transdermal patch has incorrect dosage information on pouch
Tapemark's iontoPATCH On-the-Go patches contain incorrect dosage information printed on the pouch label, though the primary carton label is correct. Approximately 5,141 cartons were distributed nationwide.
Product
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2022·2022-01-05
Percept PC Implantable Neurostimulator May Become Unresponsive During Cardioversion
The Model B35200 Percept PC Neurostimulator may become unresponsive during cardioversion procedures when circuit electronics are damaged. Affected patients should contact their healthcare provider.
Product
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0441-2022·2022-01-05
Cancer treatment linear accelerator systems recalled for wrong-site dosing risk
Siemens recalled 13 ARTISTE linear accelerator systems for cancer treatment due to a potential safety issue that could cause radiation to be delivered to the wrong treatment site.
Product
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0440-2022·2022-01-05
Siemens Atellica CH β2-Microglobulin Assay Lot 211446 Recalled for Measurement Bias
Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.
Product
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0426-2022·2022-01-05
VIDAS Clostridium Difficile GDH test substrate error causes test failure
bioMerieux recalls VIDAS Clostridium Difficile GDH diagnostic test kits due to a substrate error that prevents test execution. Affected users must retest samples, potentially delaying results.
Product
VIDAS Clostridium Difficile GDH, REF 30125-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0443-2022·2022-01-05
Medical Device Aberrometer Systems Affected by Remote Code Execution Vulnerability
AMO Manufacturing's iDesign aberrometer systems (711 units, Models G300 and G301) are vulnerable to remote code execution through the Windows Print Spooler service. An attacker could run arbitrary code with SYSTEM privileges to install programs, access or delete data, or create accounts.
Product
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
Category
Medical Device
Distribution
47 states

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13176–13200 of 40112