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

26–50 of 40397

ModerateFDA (Devices)·Z-0183-2027·2026-10-21
Medline recalls CONMED AirSeal Access Port kits due to overpressure alerts
Medline is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports because they may trigger erroneous overpressure alerts and system venting, potentially delaying or ending surgical procedures.
Product
Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C DYNJG901002D GENERAL DAVINCI DYNJG901004B DYNJG901004D…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0145-2027·2026-10-21
Ferno-Washington Power F2 Powered Fastening System Recall for Firmware Issue
Ferno-Washington is recalling 319 Power F2 Powered Fastening Systems due to a firmware issue that may cause intermittent loss of powered functionality, potentially delaying patient transport.
Product
Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0181-2027·2026-10-21
Medline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
Medline is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports due to potential for erroneous overpressure alerts and system venting during use.
Product
Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ910997A RR-DAVINCI PROSTATE ACCESSORY DYNJ63392D UROLOGY LAPAROSCOPIC - 51638…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0165-2027·2026-10-21
Howmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions
Howmedica Osteonics Corp. is recalling 582 TS Femoral Prep Trays because reprocessing instructions may lead to residual moisture after sterilization.
Product
TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0169-2027·2026-10-21
Medline recalls cardiac surgery kits with non-conforming cannula components
Medline Industries is recalling 1,834 cardiac surgery kits because cannula components do not meet ISO 80369-7 dimensional requirements, which may contribute to leaking or breaking during use.
Product
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0182-2027·2026-10-21
Medline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
Medline Industries is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports due to potential overpressure alerts and system venting that may delay or end procedures.
Product
Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0156-2027·2026-10-21
Steris RAPICIDE PA Part A High-Level Disinfectant Recalled for Pressure Hazard
Steris is recalling RAPICIDE PA Part A High-Level Disinfectant because a blocked vented cap may cause the bottle to swell and release vapor or liquid, potentially injuring users.
Product
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0167-2027·2026-10-21
Howmedica Triathlon Instrument Trays Recalled for Sterilization Dry Time Issue
Howmedica is recalling 577 Triathlon instrument trays because the provided sterilization instructions may leave residual moisture after the process.
Product
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0186-2027·2026-10-21
Intelerad IntelePACS Software Recalled for Image Display Mismatch
Intelerad Medical Systems is recalling IntelePACS software versions because reported and displayed images may not match due to a web-browser issue.
Product
IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0180-2027·2026-10-21
Medline recalls CONMED AirSeal Access Port kits due to pressure alert issues
Medline Industries is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports due to potential erroneous overpressure alerts and system venting.
Product
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0168-2027·2026-10-21
Medline surgical convenience kits recalled for non-conforming cannula components
Medline is recalling 3,125 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.
Product
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0158-2027·2026-10-21
Gore Viabil Short Wire Biliary Endoprosthesis Recalled for Incorrect Length Labeling
W L Gore & Associates is recalling 32 units of GORE VIABIL Short Wire Biliary Endoprosthesis because they may be mislabeled with the incorrect length.
Product
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0173-2027·2026-10-21
Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
Medline is recalling 620 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements, which may cause leaking or breaking during use.
Product
Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product number/SKU DYNJ42922C; 4) EAR, Medline product number/SKU DYNJ909020; 5) FEM CAROTID PACK…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0143-2027·2026-10-21
Boston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
Boston Scientific is recalling 403 units of NaviFlex LW Pusher and Advx Panc. Stent devices due to an incorrect manufacturing feature.
Product
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0163-2027·2026-10-21
Cook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
Cook Incorporated is recalling 97 Williams Cystoscopic Injection Needles because a component may not be correctly seated, potentially causing inadequate treatment.
Product
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0175-2027·2026-10-21
Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
Medline is recalling 235 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.
Product
Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0147-2027·2026-10-21
Integrated Medcraft Recalls FORWARD Gunshot Wound Kits Due to Sterile Pad Degradation
Integrated Medcraft is recalling FORWARD Gunshot Wound Kits because the sterile pad may degrade, potentially causing material to dislodge on or near wounds.
Product
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0149-2027·2026-10-21
BioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
BioFire Diagnostics is recalling specific lots of FilmArray Pneumonia Panel Plus kits due to potential contamination that could cause false positive results.
Product
Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0159-2027·2026-10-21
Microgenics Recalls MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control
Microgenics Corporation is recalling MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control products due to vial-to-vial variability that may delay patient PTH results.
Product
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0148-2027·2026-10-21
BioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
BioFire Diagnostics is recalling specific lots of FilmArray Pneumonia Panels due to potential contamination that could result in false positive test results.
Product
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0189-2027·2026-10-21
Medline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
Medline is recalling 30 Foot Ankle convenience kits due to a discrepancy in the shelf-life of a component.
Product
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0150-2027·2026-10-21
BioFire Joint Infection Panel Recalled for Potential Contamination
BioFire Diagnostics is recalling specific lots of the Joint Infection Panel due to potential contamination that could cause false positive test results.
Product
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0142-2027·2026-10-21
Neuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
Neuronetics is recalling 179 NeuroStar Advanced Therapy Systems because the cables in the HP Coil Assembly do not meet product specifications.
Product
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroStar 3.0 US; Part Number: 81-02315-000. 3. NeuroStar 2.X…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0188-2027·2026-10-21
Healthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance
Healthmark Industries is recalling 12.8 million vinyl instrument guards because their labeling does not comply with FDA regulations and steam sterilization instructions have been updated.
Product
Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0166-2027·2026-10-21
Howmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
Howmedica Osteonics Corp. is recalling 359 Triathlon Hinge Femoral Prep Trays because reprocessing instructions may leave residual moisture after sterilization.
Product
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Category
Medical Device
Distribution
0 states

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