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

6676–6700 of 40007

SevereFDA (Devices)·Z-2315-2024·2024-07-17
Baxter iLED 7 surgical lights recalled due to thermal burn risk
Baxter Healthcare is recalling iLED 7 surgical lights due to customer reports of thermal skin injuries. The recall affects approximately 6,243 units distributed worldwide.
Product
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2314-2024·2024-07-17
Baxter Trulight Surgical Lights Recalled for Thermal Skin Injuries
Baxter Healthcare Corporation recalled Trulight 5000/3000 Surgical Light systems due to customer reports of thermal skin injuries. The urgent medical device correction affects models 4038210 and 4038310 distributed worldwide.
Product
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2313-2024·2024-07-17
Baxter VidiaPort and Trulight surgical lights recalled for thermal burn risk
Baxter Healthcare Corporation is recalling VidiaPort and Trulight surgical light systems due to customer reports of thermal skin injuries. Approximately 275 units were distributed worldwide.
Product
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2253-2024·2024-07-17
BAUSCH+LOMB I-PACK Injection Kit Recalled Due to Sterilization Validation Failure
FDA has recalled 116 units of BAUSCH+LOMB I-PACK Injection Kits because sterilization certificates could not be validated by the supplier, creating potential infection risk for patients receiving intravitreal eye injections.
Product
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2343-2024·2024-07-17
Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves
Fresenius Medical Care is recalling approximately 1,156 blood pump rotor spare parts (Model F40015481 Rev A) distributed in the U.S. and Canada due to reports of loose or dislodged guide sheaves after clinical use.
Product
190395: 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-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-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-2285-2024·2024-07-17
Foot-Ankle Procedure Tray Recalled for Excessive Sterilization Residue
American Contract Systems Inc is recalling 107 units of FOOT ANKLE-LF Procedure tray distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits for permanent-implant devices.
Product
FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
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-2341-2024·2024-07-17
Blood Pump Rotor Guide Sheaves May Loosen in Home Hemodialysis System
Fresenius is recalling Blood Pump Rotor components in 2008K@HOME hemodialysis systems due to reports of loose or dislodged guide sheaves that could affect pump function. Affected patients should contact their clinic to verify involvement.
Product
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2335-2024·2024-07-17
Ophthalmic injection kit recalled over sterilization confirmation failure
MICROspecialties recalls 780 units of the Synergetics I Pack Injection Kit (Model 18069) because the company could not confirm proper sterilization, creating risk of post-operative or injection-site infections.
Product
Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2318-2024·2024-07-17
Dental abutment recall due to incorrect product packaging and labeling
Preat Corp recalled 7 units of 9006767 Astra EV 4.8mm Milled Titanium Abutments due to incorrect products being packaged and labeled. Affected units were distributed in California, Missouri, and Nevada.
Product
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2330-2024·2024-07-17
Presource Neurological Surgical Kits Recalled for Syringe Design Defect
Cardinal Health is recalling Presource neurological surgical kits containing defectively designed syringes that may cause inaccurate dosing or device leakage. The recall affects 13,487 kits distributed nationwide.
Product
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2297-2024·2024-07-17
Total Knee Procedure Kit Recalled for Excess Ethylene Oxide Residue
American Contract Systems Inc is recalling a knee surgery procedure kit (24 units, Lot 939241) due to ethylene oxide sterilization residues in the cast padding exceeding safety exposure limits for permanent-implant devices.
Product
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2299-2024·2024-07-17
TOTAL KNEE-Procedure Kit Recalled Due to Ethylene Oxide Residuals
American Contract Systems is recalling 976 units of TOTAL KNEE-Procedure Kits nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe exposure limits for medical devices.
Product
TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2024·2024-07-17
Blood Pump Rotor Spare Part Recall Due to Loose Guide Sheaves
Fresenius is recalling 17 Blood Pump Rotor spare parts nationwide due to loose or dislodged guide sheaves that develop after use. The affected rotor components are used in K@HOME dialysis machines.
Product
RTL190395: 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-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-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-2333-2024·2024-07-17
Ophthalmic Injection Kit Recall Due to Unconfirmed Sterilization
MICROspecialties is recalling the Synergetics I Pack Injection Kit because sterilization cannot be confirmed, potentially causing post-operative wound or injection site infections. Affected units are lot P62764979R distributed in Missouri.
Product
Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2320-2024·2024-07-17
Medical examination gloves recalled for skin irritation and disintegration
SVS LLC is recalling 155,540 boxes of non-sterile nitrile examination gloves due to reported skin irritation, glove disintegration with certain cleaning solutions, and size mislabeling. Gloves were distributed nationwide across eight U.S. states.
Product
Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes inc
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-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-2306-2024·2024-07-17
Surgical Procedure Kit Recalled for Ethylene Oxide Residual Contamination
American Contract Systems Inc is recalling the ACL PACK Surgical Procedure Kit due to elevated ethylene oxide and ethylene chlorohydrin residuals that exceed regulatory limits for permanent-contact medical devices.
Product
ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2024·2024-07-17
Knee Arthroscopy Procedure Kit Recalled for Sterilization Chemical Residue
American Contract Systems Inc is recalling 36 units of its knee arthroscopy procedure kit due to excessive sterilization chemical residues in the cast padding component that exceed safe exposure limits.
Product
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2290-2024·2024-07-17
Total knee prosthesis recalled for excess ethylene oxide residuals
American Contract Systems Inc is recalling 272 units of its TOTAL KNEE prosthesis nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe limits for permanent implants.
Product
TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
Category
Medical Device
Distribution
Distributed nationwide

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6676–6700 of 40007