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

3976–4000 of 39948

SevereFDA (Devices)·Z-1679-2025·2025-05-14
Intraocular Lens Recalled Due to Toxic Anterior Segment Syndrome Reports
Bausch & Lomb has recalled multiple enVista intraocular lens models used in cataract surgery due to reports of toxic anterior segment syndrome (TASS) in the United States. TASS is an inflammatory reaction in the front of the eye following lens implantation.
Product
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1717-2025·2025-05-14
CODMAN Craniotomy Kit Cranial Perforator Disposed Over Weld Defect
Integra LifeSciences is recalling CODMAN Craniotomy Kits due to inadequate welds that may cause the product to disassemble. The defect affects 1,840 units distributed worldwide.
Product
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1681-2025·2025-05-14
CADD-Solis Infusion Pump Thermal Damage Risk Recall
Smiths Medical is recalling CADD-Solis infusion pumps worldwide due to a potential for thermal damage. The affected pumps include multiple models and variants distributed in the US and internationally.
Product
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 21
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1722-2025·2025-05-14
Philips Microstream Advance Neonatal-Infant CO2 Filter Line Adapter Disconnection Risk
Philips is recalling Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines and related products because the adapter may be difficult or impossible to disconnect from the endotracheal tube.
Product
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm ,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2025·2025-05-14
Introducer Needle REF NDL-107-04 Sterile Packaging Recall
Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 due to potential open seals in sterile barrier packaging, which could compromise product sterility.
Product
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1735-2025·2025-05-14
Galt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue
Galt Medical Corporation is recalling certain Introducer Kit–Coaxial Dilator models due to potential open seals in sterile barrier packaging, which could compromise sterility.
Product
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2025·2025-05-14
GALT Centeze Catheter recalled due to potential sterile packaging seal failure
Galt Medical Corporation is recalling 2,881 GALT Centeze Catheters due to a potential open seal in the sterile barrier packaging. The open seal could compromise sterility of the device.
Product
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1733-2025·2025-05-14
B Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall
Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System (Catalog Number 612802, Model BCL-100-04, Lot S25128171) due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.
Product
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1739-2025·2025-05-14
Atalante X Powered Exoskeleton Lateral Balance Loss Recall
WANDERCRAFT SAS is recalling the Atalante X powered exoskeleton due to a potential loss of lateral balance that could cause patients to fall. Three units have been distributed to rehabilitation facilities in Pennsylvania and New York.
Product
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1728-2025·2025-05-14
Artix MT Thrombectomy Device recalled for incorrect vessel range specification
Inari Medical is recalling 45 units of the Artix MT Thrombectomy Device (REF: 32-102, Lot 24100082) because labeling specifies an incorrect vessel range of 2.5-6 mm instead of 3-6 mm, which could increase radial force on arteries and cause vascular complications.
Product
Artix MT Thrombectomy Device, REF: 32-102
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1737-2025·2025-05-14
Introducer Kit-Tearaway MicroSlide Medical Device Recall
Galt Medical Corporation is recalling Introducer Kit-Tearaway MicroSlide devices used to introduce catheters into blood vessels due to a potential open seal in the sterile barrier packaging. The affected units may not maintain sterility, creating a risk of infection.
Product
Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1718-2025·2025-05-14
Bio 1 Granules for Filling implant bone graft material nationwide recall
Bio 1 Granules for Filling implant bone granules may contain less product than specified on the label. The affected lot is 240781 (UDI: 03760154000369), distributed nationwide.
Product
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1723-2025·2025-05-14
Ambu aScope 5 Broncho HD Endoscope Labeling Error Recall
Ambu Inc. is recalling 160 units of the Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set due to incorrect front pouch labeling that states 5.0/2.2 instead of the correct size 5.6/2.8.
Product
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1734-2025·2025-05-14
GALT Guidewire SGW-051-07 Sterile Packaging Seal Defect Recall
Galt Medical Corporation is recalling GALT Guidewire model SGW-051-07 due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.
Product
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1729-2025·2025-05-14
Philips Tempus Pro Patient Monitor Software Update for Operational Issues
Remote Diagnostic Technologies Ltd. is issuing a software update for the Philips Tempus Pro Patient Monitor due to freezing, rebooting, and potential ECG measurement accuracy issues across multiple software versions.
Product
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1738-2025·2025-05-14
Blueprint Software version 4.2.1 surgical planner access bug
Tornier's Blueprint Software version 4.2.1 contains a bug that prevents surgeons from accessing surgical cases created in earlier software versions.
Product
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1719-2025·2025-05-14
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits Recalled
One lot of Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits (Model 750830) was stored at improper temperatures in Medline warehouses. The test kits may not perform as intended due to storage outside labeled requirements.
Product
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1724-2025·2025-05-14
INSPIRA AIR Balloon Dilation System packaging error corrected nationwide
Integra LifeSciences is recalling INSPIRA AIR Balloon Dilation System 10x40 cartons because an incorrect product was packaged inside. The recall affects six units distributed across Texas, Montana, Alabama, and Oklahoma.
Product
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1720-2025·2025-05-14
Washer Disinfector Aquadis 56 Model 56A pump seal defect recall
Getinge Disinfection Ab is recalling Washer Disinfector Aquadis 56 (Model 56A) units due to a frequency inverter programming error that causes the circulation pump to start earlier than expected, leading to accelerated wear on the axial seal.
Product
Washer Disinfector Aquadis 56; Model Number: 56A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1721-2025·2025-05-14
Washer Disinfector Aquadis 56 Model 56M Recalled
Getinge Disinfection Ab recalls the Washer Disinfector Aquadis 56 (Model 56M) because the frequency inverter is not programmed to specification, causing the circulation pump to start earlier than expected and wear the axial seal prematurely.
Product
Washer Disinfector Aquadis 56; Model Number: 56M
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1740-2025·2025-05-14
IntelliSpace Cardiovascular Software Echo Module Data Reporting Issue
Philips is recalling IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x because the Echo Module may generate reports with missing or incomplete information.
Product
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1732-2025·2025-05-14
B Braun Interventional Coaxial Dilator Micro-Introducer Kits Recall
Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits due to a potential open seal in the sterile barrier packaging. The affected kits are distributed nationwide in eight U.S. states and six countries.
Product
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1630-2025·2025-05-07
GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure
GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.
Product
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1629-2025·2025-05-07
GE Healthcare CARESTATION anesthesia systems may not ventilate effectively
Certain GE Healthcare CARESTATION 620, 650, 650c, 750, and 750c anesthesia delivery systems may not provide effective ventilation in Volume Control Ventilation (VCV) mode. Effective ventilation is available using other ventilation modes or manual ventilation.
Product
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1625-2025·2025-05-07
GE Healthcare CARESTATION 620 A2 Anesthesia System Ventilation Failure
Certain GE Healthcare CARESTATION anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Alternative ventilation modes or manual ventilation can be used.
Product
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide

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3976–4000 of 39948