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

1001–1025 of 39923

HighFDA (Devices)·Z-2043-2026·2026-05-06
Medline IV Start and Securement Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling multiple IV start and securement kits nationwide because they contain non-sterile Webcol Large Alcohol Prep Pads due to discovery of a bacterial contaminant during sterilization testing.
Product
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV
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-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-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-2044-2026·2026-05-06
Medline Centurion Medical Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads after Cardinal Health determined the pads are non-sterile due to bacterial contamination discovered during sterilization testing.
Product
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
Category
Medical Device
Distribution
Distributed nationwide
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-2041-2026·2026-05-06
Medline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific lots of medical convenience kits containing non-sterile Webcol Large Alcohol Prep Pads due to discovery of Paenibacillus phoenicis contamination. Affected kits were distributed nationwide.
Product
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-2005-2026·2026-05-06
epoc BGEM BUN Test Card for epoc Blood Analysis System
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards due to risk of inaccurate pH and carbon dioxide readings that could lead to inappropriate or missed treatment of acid-base disorders.
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
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-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-2025-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline is recalling 22,116 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out-of-specification. The products are distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
Category
Medical Device
Distribution
0 states
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-2006-2026·2026-05-06
Leksell Vantage Arc System locking mechanism may not secure properly
Elekta, Inc. is recalling the Leksell Vantage Arc System because locking mechanisms may fail to properly secure to the Arc system, which could cause coordinate shifting during medical procedures.
Product
Brand Name: Leksell Vantage Arc System REF: 1053958
Category
Medical Device
Distribution
32 states
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-2010-2026·2026-05-06
Medline Neuro Sponges in Medical Procedure Kits Recalled for High Endotoxin
Medline Industries is recalling Medline medical procedure kits containing Neuro Sponges (EH BRONCHOSCOPY, Kit Number DYNJT3270) 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: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
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-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-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-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-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

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1001–1025 of 39923