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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1076–1100 of 39948

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-2036-2026·2026-05-06
Medline medical procedure kits with neuro sponges recalled for endotoxin
Medline Industries is recalling approximately 7004 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that indicate out-of-specification product.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2032-2026·2026-05-06
Medline Neuro Sponges recalled for higher-than-expected endotoxin levels
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may exceed specifications.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
Category
Medical Device
Distribution
0 states
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-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-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-2022-2026·2026-05-06
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 that may exceed specifications. Approximately 21,288 kits have been distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1943-2026·2026-05-06
Mesh Style Tip Protectors recalled lacking FDA clearance
Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) distributed nationwide because the product does not have FDA clearance.
Product
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Category
Medical Device
Distribution
Distributed nationwide
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-2015-2026·2026-05-06
Medline medical procedure kits recalled for elevated endotoxin levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels detected during an internal review. Affected kits include the Major Neuro Pack-LF, Angiography Pack, and Neuro SEO models.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1991-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral Knee Component Recall
Depuy Synthes is recalling 3 units of the ATTUNE Revision Hinge Femoral (Right, Size 5, Cemented) knee implant due to external sterile packaging adhered to internal sterile packaging, potentially compromising product sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2027-2026·2026-05-06
Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline 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 (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
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-2035-2026·2026-05-06
Medline robotic hysterectomy procedure kits recalled for elevated endotoxin
Medline Industries is recalling robotic hysterectomy procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may indicate out-of-specification product in distribution worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2020-2026·2026-05-06
Medline Medical Procedure Kits With Neuro Sponges Recalled
Medline Industries is recalling medical 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: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2030-2026·2026-05-06
Medline Microdisectomy Kits Recalled for High Endotoxin Levels
Medline is recalling Microdisectomy Packs containing Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review. The affected products may be out-of-specification for endotoxin.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1948-2026·2026-05-06
Medtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
Medtronic Sphere-9 Catheters used for cardiac ablation may trigger ventricular fibrillation during radiofrequency therapy in patients with Biotronik implantable defibrillators due to an interaction between catheter current flow and a device safety feature.
Product
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2000-2026·2026-05-06
i-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results
Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges that may report falsely high CO2 and falsely low pH results due to a manufacturing issue, potentially leading to unnecessary or harmful clinical interventions.
Product
i-STAT EG6+ cartridge; List Number: 03P77-25;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2024-2026·2026-05-06
Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges because of higher-than-expected endotoxin levels that may render the product out-of-specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medl
Category
Medical Device
Distribution
0 states
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-2017-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline Industries is recalling multiple medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels. The affected kits were distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1987-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling one lot of ATTUNE Revision Hinge Femoral components (left size 7, part number 150450107) due to external sterile packaging adhered to internal packaging, potentially compromising product sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2042-2026·2026-05-06
Medline Centurion Medical Convenience Kits Recalled for Non-Sterility
Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads due to discovery of non-sterile product contaminated with Paenibacillus phoenicis bacteria during sterilization testing.
Product
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2040-2026·2026-05-06
Medline Medical Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific blood culture and blood draw kits containing Webcol Large Alcohol Prep Pads that were found to be non-sterile due to bacterial contamination discovered during a sterilization audit.
Product
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
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

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1076–1100 of 39948