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

9076–9100 of 27441

HighFDA (Devices)·Z-0420-2023·2022-12-14
Spinal implant screws recalled for potential weld separation
Integrity Implants recalls 1,369 spinal implant screws due to potential weld separation between components. No injuries have been reported.
Product
LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0378-2023·2022-12-14
Bipolar Forceps Recalled for Missing Power Supply and Cleaning Instructions
Carefusion 2200 Inc is recalling 203 units of V. Mueller SEMKIN Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing critical content related to power supply interface and cleaning/maintenance procedures.
Product
Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2023·2022-12-14
Spinal Implant Screws Recalled Due to Potential Weld Failure
LineSider Spinal System screws are recalled due to potential weld separation between components that could cause the Tulip Head to detach from the Screw Shank. The recall affects 1,227 screws distributed nationwide.
Product
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0465-2023·2022-12-14
Arthrex Small Joint OATS Sets recalled for incorrect reamer size packaging
Arthrex Small Joint OATS Sets may contain the wrong size cannulated reamer. Surgeons should verify instrument sizes before use.
Product
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0375-2023·2022-12-14
Carefusion Bipolar Forceps Recalled Due to Missing Instructions for Use
Carefusion is recalling 347 units of SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS due to incomplete Instructions for Use. The missing content covers power supply interface and maintenance procedures.
Product
Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP INSULATED, OVERALL LENGTH 7-3/4" (195MM), REF F-1003
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0366-2023·2022-12-14
Full Vision TrackMaster Treadmill Safety Tether May Fail During Fall
Full Vision Inc. is recalling TrackMaster treadmills due to a circuit defect in the safety tether. If the magnet detaches during a fall, the treadmill may fail to stop.
Product
FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0387-2023·2022-12-14
Bipolar Forceps Recall Due to Incomplete Instructions for Use
BD recalled Carefusion bipolar forceps due to missing Instructions for Use content regarding power supply interface and cleaning/maintenance. Affected units distributed nationwide and internationally.
Product
Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0461-2023·2022-12-14
Philips MRI System Recall Due to Fire and Smoke Risk
Philips SmartPath to Ingenia Elition X MR System models may produce smoke or fire due to gradient coil heat. Recall affects 566 units nationwide.
Product
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0422-2023·2022-12-14
Getinge Flow-c and Flow-e Anesthesia Systems: Backup Battery Failure Risk
Getinge Flow-c and Flow-e anesthesia systems are recalled due to backup battery defects that may fail during power outages, potentially requiring manual emergency ventilation. 65 units affected in six US states.
Product
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0371-2023·2022-12-14
2.5 mm LifePort Endotracheal Tube Adapters Deformation Risk
Bunnell's 2.5 mm LifePort Endotracheal Tube Adapters may deform due to improper packaging, potentially affecting ventilator performance. The defect may lead to hypercarbia, hypoxia, and gas trapping.
Product
2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0460-2023·2022-12-14
Philips Ingenia Elition X MR System Gradient Coil Fire and Smoke Hazard
Philips is recalling 566 Ingenia Elition X MRI systems nationwide. The gradient coil may act as a heat source with the potential to produce smoke and/or fire.
Product
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0368-2023·2022-12-14
Treadmill safety mechanism may fail to stop during fall
Full Vision Inc. Trackmaster treadmills (Model #317-07926GE) may fail to stop during a fall if the magnetic safety mechanism malfunctions. 69 units are affected.
Product
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0463-2023·2022-12-14
Philips MR 7700 System Upgrade Recalled Due to Gradient Coil Fire Risk
Philips is recalling the Upgrade to MR 7700 System (Model 782130) because the gradient coil may act as a heat source and produce smoke or fire. Affected units should not be operated until Philips provides further guidance.
Product
Philips Upgrade to MR 7700 System, Model Number 782130
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0346-2023·2022-12-07
Diagnostic Kit Recalled for False Positive Bacterial Identification Results
Accelerate Diagnostics is recalling the Accelerate PhenoTest BC kit due to improperly formulated FISH probes that produce false positive identification results for Staphylococcus aureus and Streptococcus species. Approximately 7,160 kits have been distributed across the United States and internationally.
Product
Accelerate PhenoTest BC kit REF 10102018
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-0348-2023·2022-12-07
Medical device test system recalled for decreased reactivity and false-negative results
Greer Laboratories recalled a hypersensitivity pneumonitis test kit (102 units, Lot 389592) after stability testing revealed decreased reactivity that could cause false-negative results. The issue was discovered in October 2021.
Product
GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0340-2023·2022-12-07
Intuitive Da Vinci Stapler Instruments Recalled for Potential Staple Deployment Failure
Intuitive Surgical is recalling Da Vinci Xi surgical stapling instruments due to potential staple deployment failure and device fragment generation. No injuries have been reported.
Product
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-0345-2023·2022-12-07
Accelerate PhenoTest BC Kit Recall Due to False Positive Bacterial Identification
Accelerate Diagnostics is recalling 200 kits of the Accelerate PhenoTest BC diagnostic test due to improperly formulated FISH probes that may produce false positive results for Staphylococcus aureus and Streptococcus bacteria.
Product
Accelerate PhenoTest BC kit REF 10101018
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-0342-2023·2022-12-07
CMV IgM EIA Diagnostic Test Recalled for Increased False Positives
Bio-Rad Laboratories is recalling 180 CMV IgM EIA diagnostic test kits due to unusually high rates of false positive results. The recall affects test kits distributed in 14 U.S. states.
Product
CMV IgM EIA, in vitro diagnostic.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0344-2023·2022-12-07
Mobile CT Scanner Battery Fire Risk in Units With Bypassed Monitoring
Mobius Imaging is recalling MobiCT-32 AIRO Mobile CT Scanner units due to a reported battery fire in devices where battery monitoring systems were bypassed. The affected units' batteries must be replaced.
Product
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0324-2023·2022-12-07
CoViPoint COVID Test Kits Distributed Without FDA Approval or Clearance
GS Biomark LLC distributed approximately 639,200 CoViPoint COVID test kits without FDA approval, clearance, or authorization across multiple US states.
Product
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0354-2023·2022-12-07
Alcon Surgical Procedure Packs Recalled for Adhesive Defect and Skin Injuries
Alcon is recalling Custom Pak Surgical Procedure Packs because the adhesive liner is difficult to remove and the manufacturer has observed an increase in skin injuries related to the adhesive.
Product
Alcon Custom Pak Surgical Procedure Pack
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0347-2023·2022-12-07
Medical laboratory reagent recalled for potential false-negative test results
Greer Laboratories recalled a hypersensitivity pneumonitis test reagent (Lot 389591) due to decreased reactivity that could cause false-negative results. The issue affects 218 units distributed across 12 U.S. states and two countries.
Product
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0343-2023·2022-12-07
Surgical Gown Recall Due to Potential Open Seal Pouches Affecting Sterility
Owens & Minor Distribution recalls Aero Blue Performance Surgical Gowns due to potential open seal pouches that could compromise sterility and result in non-sterile products being used in surgery.
Product
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0264-2023·2022-11-30
3M Urological Drape: Adhesive Liner Removal Issues and Skin Injuries
3M has recalled 17,200 units of urological drapes due to adhesive liner removal difficulty and reported skin injuries. The affected drapes may become unusable in surgical settings.
Product
3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0248-2023·2022-11-30
3M Steri-Drape surgical drapes recalled due to adhesive defect and skin injuries
3M is recalling 504,000 units of Steri-Drape surgical drapes worldwide because the adhesive liner is difficult to remove and may damage the product. Reported cases of adhesive-related skin injuries have been associated with the affected lots.
Product
3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
Category
Medical Device
Distribution
0 states

How to read this listing

Filters

9076–9100 of 27441