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

5976–6000 of 13666

HighFDA (Devices)·Z-2324-2024·2024-07-17
ZOLL Powerheart G5 AED shipping film may prevent shock delivery
ZOLL Powerheart G5 AED devices are shipped with a protective film on the front panel. If not removed before use, the film may prevent the shock button from being pressed, delaying or preventing defibrillation therapy.
Product
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2347-2024·2024-07-17
Blood Pump Rotor Spare Parts Recalled for Loose Guide Sheaves
Fresenius Medical Care recalls 6 blood pump rotor spare parts used in dialysis machines due to loose or dislodged guide sheaves that developed after clinical use.
Product
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2291-2024·2024-07-17
Knee Arthroscopy Pack Recalled for Excess Sterilization Residues
American Contract Systems Inc. is recalling 84 knee arthroscopy packs (Catalog Number MEKA12R) distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.
Product
KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2309-2024·2024-07-17
Orthopedic ORIF Hip Rod Procedure Kit Recalled for Sterilization Residuals
American Contract Systems Inc is recalling its ORIF HIP IM RODDING FEMUR-Procedure Kit (28 units) because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe limits for permanent implants.
Product
ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2024·2024-07-17
TOTAL KNEE Procedure Tray Recalled for Ethylene Oxide Sterilization Residuals
American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.
Product
TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2286-2024·2024-07-17
Procedure Tray Recalled Due to Excess Sterilization Residue
American Contract Systems Inc is recalling HAND WRIST FOREARM-LF Procedure trays due to ethylene oxide sterilization residues exceeding safe limits for permanent exposure devices.
Product
HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2288-2024·2024-07-17
Upper Extremity Cast Padding Recalled for Excessive Sterilization Gas Residuals
American Contract Systems Inc. is recalling 192 units of cast padding due to excessive ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for skin-contact medical devices.
Product
UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2302-2024·2024-07-17
Medical knee procedure kit recalled for excessive sterilization chemical residue
American Contract Systems Inc is recalling TOTAL KNEE-Procedure Kits due to excessive ethylene oxide and ethylene chlorohydrin residues on the cast padding component. The recall affects 85 units distributed nationwide.
Product
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2317-2024·2024-07-17
GE Vivid Ultrasound Scanner Displays Incorrect Patient Data
GE Vivid ultrasound systems may display incorrect patient names and demographics due to slow DICOM response times, risking patient misidentification during imaging.
Product
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2346-2024·2024-07-17
Hemodialysis System Blood Pump Rotor Recall Due to Loose Sheaves
Fresenius is recalling blood pump rotors in home hemodialysis systems due to loose or dislodged guide sheaves reported during clinical use. The defect could affect proper pump operation during dialysis treatment.
Product
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2024·2024-07-17
Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect
Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.
Product
Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2283-2024·2024-07-17
Orthopedic knee procedure tray recalled for sterilization residue levels
American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray because residual sterilization chemicals exceeded permissible exposure limits. The affected units were distributed nationwide.
Product
ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2282-2024·2024-07-17
Procedure Tray Recalled for Excessive Ethylene Oxide Residuals
American Contract Systems Inc is recalling 129 units of ARTHO KNEE BAPTIST SOUTH PACK Procedure trays (lot numbers 953241, 882241) due to ethylene oxide and ethylene chlorohydrin sterilization residuals exceeding safe limits for permanent-contact medical devices.
Product
ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2280-2024·2024-07-17
Arthroscopy Procedure Tray Recalled for Excess Sterilization Residue
American Contract Systems recalls the ARTHROSCOPY WOLFSON PACK BHS Procedure tray because ethylene oxide residuals on the cast padding exceeded safety limits for permanent exposure medical devices.
Product
ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2024·2024-07-17
Procedure Tray Recalled for Excess Ethylene Oxide Residue
American Contract Systems is recalling a lower extremity procedure tray (48 units) due to ethylene oxide residuals that exceed FDA safety limits for permanent exposure medical devices.
Product
LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2024·2024-07-17
Procedure Kit Recalled for Excess Ethylene Oxide Residue in Cast Padding
American Contract Systems Inc is recalling 36 units of Hand Pack procedure kits due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding regulatory limits.
Product
HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2325-2024·2024-07-17
Kosmos iOS Ultrasound Software Update Due to Measurement Accuracy Bug
Echonous Inc is recalling Kosmos ultrasound software for iOS due to a bug causing inaccurate measurements in DICOM exports, potentially leading to incorrect diagnoses.
Product
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-2300-2024·2024-07-17
Hand Draping Surgical Kit Recalled for Ethylene Oxide Residue
American Contract Systems Inc is recalling the Hand Draping SJH-Procedure Kit because residual levels of ethylene oxide and ethylene chlorohydrin exceeded safe limits for permanent-contact medical devices.
Product
HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2345-2024·2024-07-17
Hemodialysis Blood Pump Rotor Spare Part Recalled for Loose Sheaves
Fresenius Medical Care is recalling hemodialysis blood pump rotor spare parts due to reports of loose or dislodged guide sheaves. The affected model is distributed nationwide in the U.S. and Canada.
Product
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2298-2024·2024-07-17
Knee Arthroscopy Kit Recalled for Excessive Sterilant Chemical Residue
American Contract Systems Inc is recalling 270 units of a knee arthroscopy surgical kit because sterilization chemical residues exceed safe limits for permanent device contact.
Product
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2024·2024-07-17
Arthroscopy Pack Recalled for Excessive Sterilization Chemical Residue
American Contract Systems is recalling 345 units of the AHAR50K Standard Arthroscopy Pack due to ethylene oxide residue levels exceeding regulatory limits. Affected lot numbers are 638231, 962241, and 898241.
Product
AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2310-2024·2024-07-17
Hand Procedure Kit Recalled for Excess Ethylene Oxide Residuals
American Contract Systems recalls HAND PACK-Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residuals on the cast padding component, exceeding safe permanent-contact exposure limits.
Product
HAND PACK-Procedure Kit Catalog Number: WEHD16B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2270-2024·2024-07-17
24K Premium Contact Lenses Recalled Due to Potential Bacterial Contamination
Ontact Inc. is recalling 24K Premium contact lenses distributed in California and Nevada due to potential bacterial contamination.
Product
24K Premium Lense, Distributed by Updream Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2024·2024-07-17
AURORA Surgiscope System Recalled for Potential Sheath Damage
Integra LifeSciences is recalling 14 units of the AURORA Surgiscope System due to potential sheath damage that could cause tissue damage or internal bleeding.
Product
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2307-2024·2024-07-17
CUSTOM KNEE Medical Device Procedure Kit recalled for excess chemical residuals
American Contract Systems Inc is recalling 174 units of the CUSTOM KNEE - 206061-Procedure Kit due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component. The residuals exceed the safety limits specified in ANSI/AAMI/ISO 10993-7:(R)2012 for permanent-contact medical devices.
Product
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
Category
Medical Device
Distribution
Distributed nationwide

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5976–6000 of 13666