The Recall Desk

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.

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3776–3800 of 13449

  • HighFDA (Devices)·Z-1167-2025·2025-02-19

    Exactech Alteon XLE Hip Replacement Liners Recalled for Missing Barrier Layer

    Exactech is recalling Alteon XLE hip replacement liners due to a manufacturing defect. Some units lack the Ethylene Vinyl Alcohol barrier layer required for proper device function.

    Product
    Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1170-2025·2025-02-19

    Hologic Sertera-14 Biopsy Device Recalled for Inner Needle Separation Risk

    Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.

    Product
    Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2025·2025-02-19

    BD Pyxis MedStation ES Medication Cabinet Drawer and Door Failures Recalled

    The FDA is recalling BD Pyxis MedStation ES medication cabinets due to potential drawer and door failures that could delay medication access. Affected healthcare facilities should check their devices and contact the manufacturer if malfunctions occur.

    Product
    BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1165-2025·2025-02-19

    Exactech AcuMatch XLE Hip Implants Recalled Due to Missing Protective Barrier Layer

    Exactech recalled AcuMatch XLE hip implants due to the absence of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Approximately 42 units were distributed in the U.S. and internationally.

    Product
    AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL 0¿ LNR J 32MM 140-36-29 AM EHXL 0¿ LNR J 36MM 140-32-30 AM EHXL 0¿ LNR K 32MM
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1119-2025·2025-02-19

    Pyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities

    CareFusion recalls Pyxis medication dispensing systems due to software issues that could delay access to medications, result in incorrect doses, or allow unauthorized access.

    Product
    (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource Kits (surgical strips and patties used in ophthalmic procedures) due to potential endotoxin contamination in non-sterile components.

    Product
    Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2025·2025-02-19

    Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2025·2025-02-19

    Cardinal Health Robotic Hysterectomy Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in surgical strips and patties. Endotoxins are bacterial contaminants that could cause complications during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource surgical kits containing non-sterile strips and patties may be contaminated with endotoxins, posing potential risk to patients during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2025·2025-02-19

    Vios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings

    Murata Vios, Inc. is recalling the Vios Monitoring System Bedside Monitor, Model BSM2050, due to premature failure of the pulse oximeter SpO2 sensor. When the sensor fails, the system displays an incorrect warning that may mask the actual monitoring problem.

    Product
    Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2025·2025-02-19

    Diagnostic HPV Verification Panel Recalled Due to Quality Control Failures

    Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.

    Product
    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2025·2025-02-19

    Cardinal Health Urology Robotic Packs recalled for potential endotoxin contamination

    Cardinal Health Presource Kits for robotic urology surgery are being recalled due to potential endotoxin contamination in surgical strips and patties. No adverse events have been reported.

    Product
    Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2025·2025-02-19

    Cardinal Health Presource Kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits containing surgical strips and patties due to potential endotoxin contamination. Approximately 973,785 units were distributed in the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2025·2025-02-19

    Cardinal Health Presource surgical kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2025·2025-02-19

    Cardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource Kits containing laryngoscopy packs are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties.

    Product
    Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2025·2025-02-19

    Stryker Precision Thin surgical blade attachments recalled for specification defect

    Stryker is recalling Precision Thin surgical blade attachments that may be out of specification and fail to fit securely into compatible handpieces. The defect affects 238 units distributed worldwide, with no reported injuries.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1121-2025·2025-02-19

    LVIS Intraluminal Support Device May Fail to Deploy Properly

    MicoVention Terumo LVIS stent devices may fail to advance from the introducer due to PTFE material on the stent loop. Eleven units (Lot 0000456768) distributed in China are affected.

    Product
    MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1138-2025·2025-02-19

    Stryker Precision Thin Blade Attachments Recalled for Measurement Failure

    Stryker Corporation is recalling 622 units of Precision Thin blade attachments that may be out of measurement specifications, preventing them from fitting securely into compatible handpieces.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1137-2025·2025-02-19

    Cardinal Health Presource ACDF Surgical Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource ACDF surgical kits for potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses or injuries have been reported.

    Product
    Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2025·2025-02-19

    Novation XLE hip implant components recalled for missing barrier layer

    Exactech is recalling Novation XLE hip implant components due to absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer. Patients with affected implants should contact their healthcare provider.

    Product
    Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1129-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination

    Cardinal Health Presource Kits may contain endotoxin-contaminated non-sterile surgical strips and patties. These kits are used in surgical procedures and have been distributed worldwide including the US, Canada, and Saudi Arabia. Affected facilities should verify lot numbers against the recall list.

    Product
    Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling approximately 973,785 Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to healthcare facilities worldwide.

    Product
    Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2025·2025-02-19

    Spore Test Monitoring System Printing Error May Cause Result Misdirection

    HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (4,021 units) due to a printing error on return envelopes that may cause spore test results to be reported to incorrect customer accounts.

    Product
    Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-1120-2025·2025-02-19

    BD Pyxis Medication Dispensing Systems Recalled for Insufficient Labeling

    CareFusion is recalling six models of BD Pyxis medication management systems due to insufficient labeling regarding potential delays in medication access. The manufacturer is strengthening product labeling to address this risk.

    Product
    (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthes
    Category
    Medical Device
    Distribution
    Distributed nationwide