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 39968

HighFDA (Devices)·Z-2391-2024·2024-07-24
Infusomat UNIV. 15 IV Pump Set Recalled for Backflow Hazard
B. Braun Medical is recalling 32,752 units of the Infusomat UNIV. 15 DR pump tubing set due to potential backcheck valve malfunction that could cause medication backflow between IV containers and medication loss.
Product
Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2390-2024·2024-07-24
Infusion Pump Set Recalled Due to Valve Malfunction Risk
B. Braun's Infusomat UNIV. 60 infusion pump sets are recalled due to backcheck valve malfunction that may cause medication backflow from secondary to primary IV bags, risking adverse drug reactions or medication loss.
Product
Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2349-2024·2024-07-24
Cascade IOMAX Cortical Module recalled for defective circuit board
Cascade IOMAX Cortical Module devices are recalled due to a defective printed circuit board that may cause unintended electrical stimulation. Affected units were distributed in the U.S. and internationally.
Product
Cascade IOMAX Cortical Module, REF: 190296-200
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2348-2024·2024-07-24
Agilis NxT Steerable Introducer Recalled for Dilators Too Short
St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer due to dilators that are too short and will not extend outside the introducer sheath. The defect may prevent proper device function.
Product
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2374-2024·2024-07-24
BD Pyxis Automated Dispensing Cabinets Software Error Prevents Medication Access
BD Pyxis automated dispensing cabinets with ES 1.7.x software may display errors preventing medication access when Component Manager is in 'installed mode' and patch KB 5033688 is applied.
Product
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC,
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2252-2024·2024-07-17
Medical Device Recall: Bausch+Lomb Intravitreal Injection Kit Unvalidated Sterilization
Synergetics Inc is recalling Bausch+Lomb I-PACK Intravitreal Injection Kits because sterilization certificates could not be validated by the supplier. The FDA classified this as Class I.
Product
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2251-2024·2024-07-17
Bausch+Lomb I-PACK Injection Kit Recalled for Unvalidated Sterilization
Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit nationwide because sterilization certificates could not be validated by the supplier. The unvalidated sterilization of this eye injection device poses a potential infection risk.
Product
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
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-2254-2024·2024-07-17
Intravitreal Injection Kit Recalled for Unvalidated Sterilization Certificates
Synergetics Inc is recalling 35 units of the BAUSCH+LOMB I-PACK Intravitreal Injection Kit because sterilization certificates could not be validated, creating an infection risk.
Product
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-2287-2024·2024-07-17
Knee Scope Procedure Tray Recalled for Excess Sterilization Residue Levels
American Contract Systems Inc. is recalling KNEE SCOPE Procedure Tray kits because ethylene oxide sterilization residues in the cast padding component exceed safe exposure limits per FDA and ISO standards.
Product
KNEE SCOPE Procedure tray Catalog Number: COKN48L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2303-2024·2024-07-17
Arthroscopy Kit Recalled for Excessive Sterilant Residue on Padding
American Contract Systems is recalling 27 arthroscopy procedure kits because the cast padding component contains ethylene oxide and ethylene chlorohydrin residues exceeding safe limits for permanent exposure devices.
Product
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
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-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-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-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-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-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-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-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

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