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

2551–2575 of 27346

SevereFDA (Devices)·Z-1963-2025·2025-06-18
Microtek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling
Microtek Medical is recalling Patient Drape adapter plug kits (models AP6MMN and AP8MMN) because non-sterile products were labeled as sterile. The affected adapters are used to connect drain hoses to fluid management devices.
Product
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to
Category
Medical Device
Distribution
20 states
SevereFDA (Devices)·Z-1932-2025·2025-06-18
Philips Intera 1.5T Explorer/Nova Dual MRI Gradient Coil Fire Risk
Philips is recalling one Intera 1.5T Explorer/Nova Dual MRI system due to a gradient coil component that may overheat, produce smoke, or ignite, risking patient and operator injury.
Product
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1867-2025·2025-06-18
Z-800W Infusion System Recalled for Unvalidated Software Installation
Zyno Medical LLC is recalling the Z-800W Infusion System because unreleased software versions were installed on devices without verification or validation.
Product
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1866-2025·2025-06-18
Z-800F Infusion System Recall Due to Unvalidated Software Versions
Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.
Product
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1915-2025·2025-06-18
Covidien Newport HT70 and HT70Plus Ventilators Capacitor Failure Recall
Covidien is recalling Newport HT70 and HT70Plus ventilators due to capacitor failures that may cause the device to shut down unexpectedly or fail to alarm, risking respiratory failure and oxygen deprivation in patients.
Product
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1972-2025·2025-06-18
BD Texium Closed System Drug Transfer Devices May Leak at Connector
BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.
Product
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1952-2025·2025-06-18
Tecfen Medical 2.8mm Slit Knife Angled Sterility Assurance Recall
Tecfen Medical is recalling 2.8mm Slit Knife, Angled (Model QKN2808) ophthalmic surgical instruments due to sterility assurance concerns. Affected units were distributed in the US and internationally.
Product
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 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
SevereFDA (Devices)·Z-1931-2025·2025-06-18
Philips Intera 1.5T Achieva Nova-Dual MRI System Fire Hazard Recall
Philips is recalling three Intera 1.5T Achieva Nova-Dual MRI systems worldwide due to a gradient coil component failure that can generate smoke and fire, posing risks including burn injury and asphyxia.
Product
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1924-2025·2025-06-18
Azure S DR MRI SureScan Pacemakers Recalled for Battery Failure Risk
Medtronic Azure S DR MRI SureScan pacemakers may experience sudden battery power failure without warning, potentially interrupting therapy and leading to cardiac arrest or hospitalization. Affected devices are being recalled internationally.
Product
Azure S DR MRI SureScan, Product number W3DR01
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1865-2025·2025-06-18
Z-800 Infusion System recalled for unverified software installation
Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.
Product
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1936-2025·2025-06-18
Philips SmartPath to dStream 1.5T MRI Gradient Coil Fire Risk
Philips SmartPath to dStream for 1.5T MRI systems are recalled due to potential gradient coil component failure that may produce smoke and fire, posing risks of inhalation injury, burns, asphyxia, and death.
Product
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1929-2025·2025-06-18
Philips Intera 1.5T Achieva IT Nova MRI System Gradient Coil Fire Risk
Philips is recalling one Intera 1.5T Achieva IT Nova MRI system due to a gradient coil component that may overheat and produce smoke or fire, posing risks of inhalation injury, burns, or death.
Product
Intera 1.5T Achieva IT Nova Product Number: 781175
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1868-2025·2025-06-18
Z-800WF Infusion System software verification defect recall
Zyno Medical LLC is recalling 613 units of the Z-800WF Infusion System because unreleased software versions were installed on distributed devices without verification or validation.
Product
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1921-2025·2025-06-18
SOLTIVE Premium SuperPulsed Laser System surgical instrument thermal incident
Olympus is recalling the SOLTIVE Premium SuperPulsed Laser System due to risk of thermal incidents including smoke, sparks, burning, or flames during clinical use caused by fiber fracturing.
Product
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and f
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-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-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-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-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-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-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-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-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

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2551–2575 of 27346