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

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1101–1125 of 39948

  • HighFDA (Devices)·Z-2026-2026·2026-05-06

    Medline Medical Procedure Kits Recalled for Higher Endotoxin Levels

    Medline Industries is recalling medical procedure kits containing neuro sponges worldwide because testing found higher-than-expected endotoxin levels, indicating products may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2009-2026·2026-05-06

    Medline Neuro Sponges in Pediatric Airway Kits recalled for endotoxin

    Medline Industries is recalling Pediatric Airway Procedure Kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out of specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2038-2026·2026-05-06

    Medline Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline is recalling certain medical procedure kits containing neuro sponges because they may have higher-than-expected endotoxin levels, indicating out-of-specification product in the market.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1992-2026·2026-05-06

    Depuy Synthes ATTUNE Revision Hinge Femoral implants recalled for sterility risk

    DePuy Synthes is recalling ATTUNE Revision Hinge Femoral knee implants because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2026·2026-05-06

    WHILL Model C2 Powered Wheelchair Recalled for Bluetooth Security Vulnerability

    WHILL Model C2 powered wheelchairs with software versions before HMI 2.22 and MC 1.13 are recalled due to a Bluetooth Low Energy (BLE) communication vulnerability identified by CISA. Approximately 4,685 units distributed in Kansas are affected.

    Product
    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2001-2026·2026-05-06

    Abbott i-STAT Blood Gas Cartridges Reporting Inaccurate pH and PCO2 Results

    Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+, i-STAT EG6+, and i-STAT EG7+ blood gas cartridges due to a manufacturing issue causing falsely high PCO2 and low pH readings, which may lead to unnecessary or harmful clinical interventions.

    Product
    i-STAT G3+ cartridge; List Number: 03P78-26;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall

    DePuy Synthes is recalling 3 units of the ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM due to external sterile packaging found adhered to internal packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1995-2026·2026-05-06

    Straumann n!ce Zr HT Dental Implant Abutments Recalled for Incorrect Screw Seat

    Straumann USA LLC is recalling 6 units of Straumann n!ce Zr, HT endosseous dental implant abutments (Article 010.0158) due to an incorrect screw seat interface that could affect proper implant function.

    Product
    Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2019-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

    Medline is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review, indicating in-market product may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. O
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2023-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

    Medline Industries is recalling three medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels identified during internal review. The affected kits may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ90836
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2011-2026·2026-05-06

    Medline medical procedure kits recalled for out-of-specification endotoxin levels

    Medline Industries is recalling medical procedure kits containing Neuro Sponges for spinal fusion due to higher-than-expected endotoxin levels that may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2045-2026·2026-05-06

    Medline medical convenience kits recalled for non-sterile alcohol prep pads

    Medline Industries is recalling multiple medical convenience kits nationwide due to Webcol Large Alcohol Prep Pads that were found to be non-sterile. A contaminant (Paenibacillus phoenicis) was discovered during a routine sterilization dose audit.

    Product
    Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2026·2026-05-06

    Philips Achieva 1.5T MRI Scanner Stiffness Calculation Error Recall

    Philips is recalling Achieva 1.5T MRI systems with MR Elastography software due to potential stiffness value errors that may occur with specific image reconstruction parameters, causing incorrect voxel size display in the default scan protocol.

    Product
    Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2013-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled

    Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may be out of specification. The kits were distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2028-2026·2026-05-06

    Centurion Surgical ENT Prep Kits with Medline Neuro Sponges Recalled

    Medline Industries is recalling Centurion Surgical ENT Prep Kits (Medline Neuro Sponges) due to higher-than-expected endotoxin levels that may render the product out-of-specification. Approximately 3,000 kits have been distributed worldwide.

    Product
    Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1954-2026·2026-05-06

    Philips Evolution Upgrade 1.5T MRI Stiffness Calculation Error

    Philips North America is recalling Philips Evolution Upgrade 1.5T MRI systems with MR Elastography due to potential stiffness value errors that may result in incorrect voxel size settings in the default scan protocol.

    Product
    Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2026·2026-05-06

    Straumann n!ce PMMA Dental Implant Abutments Recalled for Screw Seat Defect

    Straumann USA LLC is recalling Straumann n!ce PMMA Full-arch Restoration screw-retained bridge abutments (Article 010.0304) due to an incorrect screw seat interface. Five units were distributed to dental offices in eight states.

    Product
    Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2003-2026·2026-05-06

    Philips Bridge Prep Kit catheter may experience resistance during advancement

    Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.

    Product
    Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2026·2026-05-06

    Philips SmartPath to dStream MR Elastography Software Parameter Error

    Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.

    Product
    Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2026·2026-05-06

    Disposable Mixing Bowls with Spatula recalled for compromised sterile barrier

    Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to package seal defects that may compromise the sterile barrier. Ten complaints have been received identifying incomplete seals, wrinkles, or peeling seals.

    Product
    Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1953-2026·2026-05-06

    Philips Achieva 3.0T MR Elastography system stiffness value error recall

    Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific parameters are used, which may cause incorrect voxel size display in the default scan protocol.

    Product
    Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1959-2026·2026-05-06

    Philips Ingenia 3.0T CX MRI System MR Elastography Software Issue

    Philips is recalling Ingenia 3.0T CX MRI systems with MR Elastography due to potential stiffness value errors caused by specific image reconstruction parameters and Resoundant algorithm settings, resulting in incorrect voxel size displays in the default MRE scan protocol.

    Product
    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral implant sterility concern

    DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT SZ 8 CEM implants due to external sterile packaging adhered to internal sterile packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2004-2026·2026-05-06

    Philips Bridge Prep Kit catheter may experience resistance during advancement

    Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.

    Product
    Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1949-2026·2026-05-06

    Genius Review Station Display Modified Outside Validated Configuration

    Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.

    Product
    Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics S
    Category
    Medical Device
    Distribution
    Distributed nationwide