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

3726–3750 of 39824

HighFDA (Devices)·Z-1925-2025·2025-06-18
Digital Acquisition Box Electrode Placement Labels Applied Backwards
Natus Neurology has recalled the OBM00002 OBM DAB (Digital Acquisition Box) because electrode placement labels were applied backwards. This may lead to misdiagnosis of seizure location in neonates monitored with the device.
Product
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1975-2025·2025-06-18
SmartRelease Onyx Blade Assembly Surgical System Recalled
MicroAire Surgical Instruments is recalling the SmartRelease ESTR Onyx Blade Assembly due to a potential risk that the blade can unintentionally cut tissue before the user deploys it.
Product
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1971-2025·2025-06-18
BD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface
BD Texium Needle-Free Syringes (multiple sizes) may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, medication underdosing, or exposure to hazardous drugs.
Product
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1922-2025·2025-06-18
Soltive SuperPulsed Laser Fibers recalled for thermal incident risk
Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser Fibers due to potential fiber fracturing that can cause thermal incidents including smoke, sparks, burning, or unsteady flames during clinical use.
Product
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1918-2025·2025-06-18
Kendall SCD Comfort Sleeves Pediatric Knee Length Software Error Recall
Kendall SCD Comfort Sleeves Knee Length Small Pediatric models may experience frequent E1 errors due to incorrect software logic, potentially delaying treatment or therapy.
Product
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1917-2025·2025-06-18
SCD Comfort Knee Length sleeves recalled for software logic errors
Cardinal Health is recalling SCD Comfort Knee Length Small sleeves (SKU 84021) due to incorrect software logic that may cause frequent E1 errors and delay patient treatment.
Product
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1956-2025·2025-06-18
Contact Lens Insertion Solution Recalled for Potential Sterility Defect
Contamac Nutrifill Physiologic formula contact lens insertion solution is being recalled because it may lack sterility. The affected product was distributed nationwide.
Product
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1819-2025·2025-06-18
OEC Elite and OEC 3D Mobile C-Arms X-ray Field Size Exceeds Limit
GE Medical Systems is recalling certain OEC Elite and OEC 3D mobile C-arm systems that may produce X-ray fields exceeding acceptable limits. Some units also lack proper acceptance limits in their service manuals.
Product
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1820-2025·2025-06-18
OEC Elite and OEC 3D Mobile C-Arms X-ray Field Size Defect
GE Medical Systems is recalling certain OEC Elite and OEC 3D mobile C-arm imaging systems because some units may produce X-ray fields that exceed acceptable limits, posing a potential radiation safety risk.
Product
OEC 3D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1920-2025·2025-06-18
SOLTIVE Pro SuperPulsed Laser System surgical instrument thermal incident
Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System due to risk of unexpected smoke, sparks, burning, or unsteady flames caused by fiber fracturing during clinical use.
Product
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1949-2025·2025-06-18
Tecfen Medical 15 degree Stab Knife sterility assurance recall
Tecfen Medical is recalling its 15 degree Stab Knife (Model QKN1501) due to sterility assurance concerns. The ophthalmic knife is used in eye surgeries and was distributed in the US and internationally.
Product
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives ar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1957-2025·2025-06-18
KWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up
Microbiologics Inc is recalling KWIK-STICK quality control kits because products were packaged with incorrect microorganism swabs, which may lead to delayed diagnosis of patient samples in clinical laboratories.
Product
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1966-2025·2025-06-18
Allon 2001 Medical Device Heating System Malfunction Risk
Belmont Instrument's Allon 2001 device may heat water above safe limits if sensor connections fail and temperature alarms are disabled. The patient wrap may exceed its set temperature without user notification.
Product
Allon 2001. Part Number: 200-00263
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1965-2025·2025-06-18
iBOT PMD Personal Mobility Device Software Update Recall
Mobius Mobility LLC is recalling 442 units of the iBOT PMD (Personal Mobility Device) with software version 01.05.24 due to a software issue that could cause the device to tip over during Balance Mode operation.
Product
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1973-2025·2025-06-18
BD TEXIUM Closed Male Luer Drug Transfer Device Recall
BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1939-2025·2025-06-18
Femoral Nail T2 GTN Left and Right Versions Mislabeled
Stryker GmbH is recalling certain Femoral Nail T2 GTN devices because some labeled as left version contained right nails, and vice versa. This mislabeling could result in incorrect surgical implantation.
Product
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1954-2025·2025-06-18
Tecfen Medical 2.0mm Crescent Knife Ophthalmic Device Recall
Tecfen Medical is recalling 2.0mm Crescent Knife ophthalmic surgical instruments (Model QKN1010, Lot ZGY24071501-03) due to sterility assurance concerns. The affected devices were distributed in the US and internationally.
Product
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent kn
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1938-2025·2025-06-18
MUSE 5 Cardiovascular Systems Recall Administrator Credential Access
GE Medical Systems is recalling MUSE 5 Systems due to a vulnerability that could allow unauthorized access to patient data. The MUSE Administrator Account credentials could potentially be used to log into affected systems from the local network and manipulate recorded cardiovascular patient data.
Product
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1970-2025·2025-06-18
Alaris Pump Infusion Sets may leak at male luer connections
BD Switzerland is recalling multiple Alaris Pump Infusion Set models worldwide due to potential leaks at the connection between the closed male luer component and needle-free connector, which could delay procedures, interrupt treatment, expose patients to hazardous drugs, or result in underdosing.
Product
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1951-2025·2025-06-18
Tecfen Medical 2.4mm Slit Knife Angled Ophthalmic Knife Recall
Tecfen Medical is recalling its 2.4mm Slit Knife, Angled (Model QKN2461) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for controlled entry into the eye.
Product
Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1962-2025·2025-06-18
Baxter Healthcare 2.5V Rechargeable Batteries for PocketScope Handles
Baxter Healthcare is recalling 2.5V rechargeable batteries for Welch Allyn PocketScope handles due to potential short circuits that can cause excessive heat and user burns.
Product
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1919-2025·2025-06-18
Kendall SCD Blended Comfort Sleeves Recalled for Software Logic Error
Cardinal Health is recalling Kendall SCD Blended Comfort Sleeves (Knee Length Small, SKU 84021B) due to incorrect software logic that may cause frequent E1 errors. The issue may delay treatment or therapy.
Product
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1933-2025·2025-06-18
Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall
Philips is recalling two Intera 1.5T MRI systems due to a gradient coil component failure that can produce smoke or fire, posing risks of inhalation injury, burns, asphyxia, or death.
Product
Intera 1.5T Master/Nova Product Number: 781106;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1916-2025·2025-06-18
Medical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination
American Contract Systems, Inc. is recalling convenience kits containing cast padding due to elevated ethylene oxide and ethylene chlorohydrin residuals that may cause loss of functionality and delay treatment.
Product
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1940-2025·2025-06-18
Femoral Nail RIGHT T2 GTN 8x300 mm labeled incorrectly
Stryker GmbH is recalling Femoral Nail RIGHT T2 GTN 8x300 mm devices because some lots were labeled as left or right but contained the opposite orientation.
Product
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Category
Medical Device
Distribution
Distributed nationwide

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3726–3750 of 39824