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 deaths or serious injuries are reported, 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

12426–12450 of 13816

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 arthropl
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
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-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-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-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-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-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-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-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
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-0430-2022·2022-01-05
VIDAS Measles IgG Test Kit Recalled Due to Substrate Error
bioMerieux is recalling VIDAS Measles IgG test kits due to a substrate error that prevents the test from running, requiring users to repeat testing and potentially delaying results.
Product
VIDAS Measles IgG (MSG), REF 30219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0423-2022·2022-01-05
Speech Generation Device Charging Components Recalled for Fire and Electric Shock Hazard
Forbes Rehab Services is recalling Monoprice charging cables and iClever charging bricks for ProSlate Speech Generation Devices due to fire and electric shock risks if cables are damaged or charging occurs near moisture.
Product
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0421-2022·2022-01-05
FLOWFLEX COVID-19 Rapid Test Recalled for Inadequate Validation
Migo Trading LLC recalls 200,100 FLOWFLEX COVID-19 rapid self-tests due to inadequate validation and lack of FDA emergency use authorization. The test cannot be reliably used to detect COVID-19 infection.
Product
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0419-2022·2022-01-05
da Vinci SP Surgical System Software Energy Delivery Defect
Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.
Product
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0444-2022·2022-01-05
Catalys Precision Laser System recalled for remote code execution vulnerability
AMO Manufacturing is recalling Catalys Precision Laser Systems due to a Windows Print Spooler vulnerability that could allow unauthorized remote code execution with system privileges.
Product
Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)
Category
Medical Device
Distribution
47 states
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-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-0425-2022·2022-01-05
VIDAS diagnostic test for C. difficile recalled due to substrate defect
bioMerieux's VIDAS Clostridium difficile diagnostic test is being recalled due to a substrate error that prevents the test from running. Users must re-test samples, potentially delaying diagnosis.
Product
VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0428-2022·2022-01-05
VIDAS procalcitonin diagnostic test substrate error causes testing delays
Nationwide recall of VIDAS procalcitonin test kits for substrate defects that prevent testing and require retesting, potentially delaying diagnostic results.
Product
VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
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-0429-2022·2022-01-05
VIDAS Mumps IgG diagnostic test kit recalled due to substrate error
bioMerieux is recalling one lot of VIDAS Mumps IgG diagnostic tests because a substrate error prevents the tests from running, causing delays.
Product
VIDAS Mumps IgG (MPG), REF 30218
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0439-2022·2022-01-05
VIDAS SARS-COV-2 Diagnostic Test Recalled for Substrate Error
bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying results.
Product
VIDAS SARS-COV-2 IgG, Ref 423834-01
Category
Medical Device
Distribution
Distributed nationwide

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12426–12450 of 13816