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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

51–75 of 27298

  • HighFDA (Devices)·Z-2973-2026·2026-08-26

    Beckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect

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

    Product
    Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2969-2026·2026-08-26

    Gentherm Medical Recalls Innercool Coolblue Console Due to Overheating Risk

    Gentherm Medical is recalling 46 Innercool Coolblue Console units because overheating of the 115V CPU board may cause the device to shut down.

    Product
    Innercool Coolblue Console, Model STx; Thermal regulating 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-2964-2026·2026-08-26

    AVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error

    AVID Medical, Inc. is recalling 40 packs of Halyard LAVH PACK kits because a component was improperly sterilized, potentially causing leaks.

    Product
    Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2989-2026·2026-08-26

    Medicom Recalls Neurological Sponges Due to Endotoxin Variability

    Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.

    Product
    American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2963-2026·2026-08-26

    Maquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission

    Maquet Critical Care AB is recalling nine Y Sensor Modules for the SERVO-U/-N ventilator systems because they did not undergo required electrical safety and functional tests during production.

    Product
    GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2982-2026·2026-08-26

    Medtronic MiniMed 780G Insulin Pumps Recalled for Chemical Damage Risk

    Medtronic is recalling 257 MiniMed 780G insulin pumps distributed in Europe because chemical cleaning agents may have damaged the devices, risking incorrect insulin delivery.

    Product
    MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2986-2026·2026-08-26

    ConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage

    ConvaTec is recalling Esteem Body Soft Convex Urostomy Pouches because they may leak from the cap during use.

    Product
    Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2966-2026·2026-08-26

    Siemens Immulite 2000 Syphilis Screen Recalled for Negative Bias

    Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.

    Product
    Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
    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-2990-2026·2026-08-26

    Medicom Recalls Neurological Sponges Due to Endotoxin Variability

    Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.

    Product
    American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2965-2026·2026-08-26

    Siemens Immulite 2000 Syphilis Screen Recall for Negative Bias

    Siemens Healthineers is recalling 24 units of the Immulite 2000 Syphilis Screen assay due to a potential negative patient bias that may report low reactive results as nonreactive.

    Product
    Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2954-2026·2026-08-26

    Dentsply Sirona Capsule Mixer Recalled for Electrical Discharge Risk

    SDI Limited is recalling 1,444 Dentsply Sirona Capsule Mixers due to a potential for electrical discharge when the unit is unplugged.

    Product
    Dentsply Sirona Capsule Mixer Model No. 5546068
    Category
    Medical Device
    Distribution
    48 states
  • 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-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
  • 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-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
  • HighFDA (Devices)·Z-2912-2026·2026-08-19

    Microvention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects

    Microvention Inc. is recalling 5,500 Bobby Balloon Guide Catheters worldwide due to an increased rate of balloon pinhole defects.

    Product
    BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2936-2026·2026-08-19

    BioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results

    BioFire Diagnostics is recalling 2,370 pouches of the BIOFIRE Respiratory Panel 2.1 test due to an increase in false negative results.

    Product
    BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2948-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

    Cardinal Health 200, LLC is recalling 52,699 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.

    Product
    Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2944-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability

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

    Product
    Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2947-2026·2026-08-19

    Cardinal Health Recalls Neurological Procedure Kits Due to Endotoxin Variability

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

    Product
    Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP9
    Category
    Medical Device
    Distribution
    Distributed nationwide