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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76–100 of 39760

  • HighFDA (Devices)·Z-2974-2026·2026-08-26

    Beckman Coulter DxC 500 AU Analyzer Software Defect Recall

    Beckman Coulter is recalling DxC 500 AU Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.

    Product
    Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2026·2026-08-26

    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall

    Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection System Plus catheters due to a potential for arterial sheath tip separation during use.

    Product
    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2987-2026·2026-08-26

    restor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect

    restor3d Inc. is recalling 59 Veritas Standard Glenoid Baseplates because incorrect machining of peripheral screw holes may cause improper screw engagement.

    Product
    Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2967-2026·2026-08-26

    Paragonix KidneyVault Portable Renal Perfusion System Recalled for Firmware Defect

    Paragonix Technologies is recalling 1,445 KidneyVault Portable Renal Perfusion Systems because a firmware defect may cause the device to lose configuration, resulting in a blank screen and loss of displayed preservation parameters.

    Product
    Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2872-2026·2026-08-26

    BD Needle Kit for Powered Driver Recall Due to Removal Difficulty

    Bard Access Systems is recalling BD Needle Kits for Powered Drivers because the obturator may lock to the hub, potentially delaying emergency therapy.

    Product
    BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Dr
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2977-2026·2026-08-26

    Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation

    Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection Systems due to a potential for arterial sheath tip separation or partial tip separation during use.

    Product
    Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2958-2026·2026-08-26

    Arrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns

    Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because they did not undergo a required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.

    Product
    Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2968-2026·2026-08-26

    Gentherm Medical Recalls Blanketrol II Thermal Regulating Systems

    Gentherm Medical is recalling 182 Blanketrol II Model 222S thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.

    Product
    Blanketrol II Model 222S; Thermal regulating system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2951-2026·2026-08-26

    Foundation Medicine Recalls Hamilton Microlab STAR Liquid Handler Software

    Foundation Medicine is recalling 32 Hamilton Microlab STAR Liquid Handler units due to a software issue causing spontaneous closures.

    Product
    Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2940-2026·2026-08-26

    Spectral Instruments Recalls 35 Ami HTX X-Ray Units

    Spectral Instruments Inc is recalling 35 Ami HTX units because the 'X-Ray On' banner may briefly disappear during the run readiness check.

    Product
    Ami HTX
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2971-2026·2026-08-26

    Paragon 28 Recalls Custom Foot Implant Due to Material Defect

    Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.

    Product
    Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2950-2026·2026-08-26

    EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags

    FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.

    Product
    EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2957-2026·2026-08-26

    Kico Knee Innovation Recalls ARVIS Surgical Navigation System Due to Sensor Issue

    Kico Knee Innovation is recalling 78 ARVIS Surgical Navigation System Gen 2 units because an internal sensor issue may cause the eyepiece image to appear tilted.

    Product
    Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system is
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2972-2026·2026-08-26

    Paragon 28 Recalls Custom Foot Implant Due to Material Defect

    Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.

    Product
    Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2920-2026·2026-08-19

    Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects

    Covidien is recalling Dermalon 4-0 sutures because sterile barrier packaging may be perforated or torn, risking biocontamination and infection.

    Product
    Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2873-2026·2026-08-19

    Spectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns

    Spectra Medical Devices is recalling Sodium Chloride Injection ampules because manufacturing issues may have compromised sterility, posing a risk of infection or inflammation to patients.

    Product
    Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2938-2026·2026-08-19

    Erbe ERBECRYO 2 Cryosurgical Unit Recalled Due to Rupture Risk

    Erbe USA Inc is recalling ERBECRYO 2 Cryosurgical Units because a strong pull on the high-pressure transfer hose may cause the cryoprobe to rupture.

    Product
    ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2922-2026·2026-08-19

    Surgipro II Sutures Recalled for Potential Sterile Barrier Defects

    FDA is recalling Surgipro II sutures due to potential sterile packaging defects that could cause biocontamination and infection.

    Product
    Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2932-2026·2026-08-19

    Philips Azurion Fluoroscopy System Recall for Software Image Quality Issues

    Philips is recalling 2,016 Azurion interventional fluoroscopic x-ray systems worldwide due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.

    Product
    Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2924-2026·2026-08-19

    Medline Bleach Wipes Recalled for Reduced Disinfection Effectiveness

    Medline is recalling Micro-Kill Bleach Germicidal Wipes because reduced bleach concentration may compromise disinfection effectiveness, potentially allowing pathogenic microorganisms to survive.

    Product
    Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2026·2026-08-19

    Baxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing

    Baxter Healthcare is recalling 24,528 units of Duo-Vent Solution Sets due to customer reports of air bubbles in the drip chamber and tubing.

    Product
    Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2945-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

    Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.

    Product
    Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2921-2026·2026-08-19

    Surgipro Sutures Recalled for Potential Sterile Barrier Perforation

    FDA is recalling Surgipro sutures due to potential sterile barrier defects that could cause biocontamination and infection.

    Product
    Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
    Category
    Medical Device
    Distribution
    Distributed nationwide