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

3776–3800 of 39948

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-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-1974-2025·2025-06-18
BD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
BD TEXIUM closed male luer drug transfer devices may leak at the interface between the closed male luer component and the needle-free connector, potentially causing procedure delays, treatment interruptions, hazardous drug exposure, and medication underdosing.
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-1927-2025·2025-06-18
EPIONE Stereotactic Device Software Bug Poses Instrument Guidance Risk
The EPIONE Model 30-0001 stereotactic device is recalled due to a software bug that may cause the robotic arm to incorrectly guide surgical instruments during CT-guided ablation procedures. Four units have been distributed in the U.S.
Product
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography
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-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-1914-2025·2025-06-18
Stryker Gamma4 Long Nail with incorrect left-nail geometry recalled
Stryker GmbH is recalling a specific lot of Gamma4 Right Long Nails (Catalog Number 84250320S) because they were manufactured with left-nail geometry instead of right-nail geometry, which could affect surgical fit and function.
Product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
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
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-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-1950-2025·2025-06-18
Tecfen Medical 2.2mm Slit Knife ophthalmic device sterility recall
Tecfen Medical is recalling its 2.2mm Slit Knife (Model QKN2261) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for eye surgery.
Product
Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 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-1948-2025·2025-06-18
Solana Bordetella Complete Assay Kit Recalled for False Positive Results
Ortho-Clinical Diagnostics is recalling the Solana Bordetella Complete Assay Kit (Model M308) because it may produce false positive results for Bordetella parapertussis at a rate of up to 16.7%.
Product
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1955-2025·2025-06-18
Tecfen Medical 3.2mm Slit Knife Angled Ophthalmic Knife Sterility Recall
Tecfen Medical is recalling the 3.2mm Slit Knife, Angled model QKN3261 due to sterility assurance concerns. The recall affects units distributed nationwide in Connecticut and Minnesota as well as internationally.
Product
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to crea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1923-2025·2025-06-18
Soltive Reusable Laser Fibers Recalled for Thermal Incident Risk
Olympus Corporation of the Americas is recalling Soltive Reusable Laser Fibers due to risk of thermal incidents including smoke, sparks, burning, or unsteady flames during surgery, caused by fiber fracturing.
Product
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-J
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-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
ModerateFDA (Devices)·Z-1964-2025·2025-06-18
Baxter Novum IQ Syringe Pump Design Issue Recall
Baxter is recalling certain Novum IQ Syringe Pumps manufactured or repaired after July 4, 2023, due to a design issue that may falsely detect a syringe flange when none is loaded, causing the pump interface to become stuck or display a System Error 21502.
Product
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1926-2025·2025-06-18
DxI 9000 Access Immunoassay Analyzer software version 1.20 recall
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to incorrect motor/encoder and cable installation that causes error codes, prevents assays from running, and delays result generation.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2025·2025-06-18
Guardian System 2 Controller Software Battery Alert Display Issue
Turncare is recalling Guardian System 2 Controllers due to a software issue where low and terminal battery alerts do not display on the screen in certain circumstances when the device is not running patient therapy.
Product
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1968-2025·2025-06-18
Guardian System 2 Controller units recalled for battery alert display defect
Turncare has recalled certain Guardian 2 System controllers because a software issue prevented "low" and "terminal" battery alerts from displaying on the screen in specific circumstances when the device was not running patient therapy.
Product
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1947-2025·2025-06-18
Thermo SCIENTIFIC Sensititre Mueller-Hinton Broth diagnostic device recalled
Remel, Inc. is recalling one lot of Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth due to off-color that may affect performance of this in-vitro diagnostic device.
Product
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1937-2025·2025-06-18
BD BBL CultureSwab EZ Collection and Transport System Swabs Breakage
BD BBL CultureSwab EZ Collection and Transport System (REF 220144) is being recalled because swabs may break during use. The recall affects units distributed nationwide in Maryland.
Product
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Category
Medical Device
Distribution
Distributed nationwide

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3776–3800 of 39948