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

626–650 of 5100

SevereFDA (Devices)·Z-1727-2025·2025-05-21
iGo2 DC Car Adapter Recall: Overheating and Housing Deformation Risk
Medical Depot Inc. is recalling 89,532 units of the iGo2 DC Car Adapter used with iGo2 Portable Oxygen Concentrator Systems. The DC power supply housing may become excessively hot to the touch and deform, posing a burn and fire hazard.
Product
iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1698-2025·2025-05-21
AirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (model AH265) because adapters may disconnect during setup or use, potentially interrupting ventilation to newborns. Disconnection can cause hypoxia, hypercapnia, and organ failure.
Product
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Compone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1725-2025·2025-05-21
Welch Allyn Life2000 Ventilation System Recalled for Cybersecurity Vulnerability
Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation system due to a cybersecurity vulnerability discovered through internal testing. The recall affects 4,881 units distributed worldwide.
Product
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1697-2025·2025-05-21
AirLife Infant Heated Wire Circuit Adapter Disconnection Risk
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (Model AH165) because adapters may disconnect during setup or use, interrupting ventilation to infants and potentially causing severe complications.
Product
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas bet
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1750-2025·2025-05-21
TufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
LeMaitre Vascular is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete seals on some packages that compromise the sterile barrier. Affected units were distributed nationwide and internationally.
Product
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1730-2025·2025-05-21
MedicaLyte Liquid Bicarbonate Concentrate Recalled for Foreign Matter
Nipro Renal Solutions USA is recalling MedicaLyte Liquid Bicarbonate Concentrate (models BC+201 and BC+100) due to the potential presence of visible foreign matter in the product.
Product
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1726-2025·2025-05-21
Welch Allyn Life2000 Compressor recalled for cybersecurity vulnerability
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Compressor units due to a cybersecurity vulnerability discovered during internal testing.
Product
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1763-2025·2025-05-21
LifeShield Infusion Safety Software Recalled for Drug Library Defects
ICU Medical is recalling LifeShield Drug Library Management software v2.1 and v2.2 due to defects that could allow over-delivery of medication to patients or unauthorized modification of drug parameters.
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1662-2025·2025-05-14
CADD Solis HSPCA Pump wireless connection alarm interruption recall
Smiths Medical is recalling CADD Solis HSPCA Pumps with wireless connection modules that may experience intermittent connection alarms, interrupting active infusions and risking serious patient injury or death.
Product
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1667-2025·2025-05-14
CADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
Smiths Medical is recalling CADD-Solis and CADD-Solis VIP ambulatory infusion pumps because they may trigger a false upstream occlusion alarm that interrupts therapy, risking serious patient injury or death.
Product
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1668-2025·2025-05-14
CADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
Smiths Medical is recalling CADD-Solis VIP Ambulatory Infusion Pumps due to false Upstream Occlusion Alarms that may interrupt medication infusions, risking serious patient injury or death.
Product
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-0
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-1682-2025·2025-05-14
CADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
Smiths Medical is recalling CADD Solis VIP Ambulatory Infusion Pumps due to potential thermal damage. The recall affects 313,676 units distributed nationwide and worldwide.
Product
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1680-2025·2025-05-14
Intraocular Lenses enVista Envy and Envy Toric Recalled
Bausch & Lomb is recalling enVista Envy and enVista Envy Toric intraocular lenses due to increased reports of toxic anterior segment syndrome (TASS) following implantation.
Product
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Category
Medical Device
Distribution
Distributed nationwide
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-1716-2025·2025-05-14
CODMAN Disposable Cranial Perforator 14mm Recalled Due Weld Issue
Integra LifeSciences is recalling CODMAN Disposable Perforators (14mm) due to inadequate welds that could cause disassembly during use. The affected devices have been distributed worldwide.
Product
CODMAN Disposable Perforator, 14mm. Cranial perforator.
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
SevereFDA (Devices)·Z-1700-2025·2025-05-07
Posterior Femoral Augment with Missing Screw Thread Recalled
Waldemar Link is recalling Posterior Femoral Augments used in knee surgery because some units were delivered with a preassembled screw missing its thread, which could compromise surgical fixation.
Product
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1626-2025·2025-05-07
GE Healthcare Carestation 620 SE Anesthesia System Ventilation Defect Recall
GE Healthcare is recalling certain Carestation 620 SE anesthesia systems (27 units) because they may not provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.
Product
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1637-2025·2025-05-07
GE Healthcare CARESTATION 750c A1 Anesthesia System Ventilation Defect
GE Healthcare CARESTATION 750c A1 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Affected units can achieve ventilation through alternative modes or manual operation.
Product
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. 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-1624-2025·2025-05-07
GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.
Product
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1632-2025·2025-05-07
GE Healthcare CARESTATION 650C A1 Anesthesia System Ventilation Recall
GE Healthcare CARESTATION 650C A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Ventilation can be achieved using alternate modes or manual ventilation.
Product
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1636-2025·2025-05-07
GE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall
Certain GE Healthcare CARESTATION 750 A2 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Users should switch to Pressure Control Ventilation or Manual ventilation modes.
Product
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1695-2025·2025-05-07
Quantum Informatics VIPER Physiological Monitor Recalled for Lack of FDA Clearance
Spectrum Medical Ltd. is recalling the Quantum Informatics VIPER, a patient monitoring software device, because it was marketed without required FDA clearance. The software is used in operating rooms to provide patient safety information.
Product
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice soluti
Category
Medical Device
Distribution
38 states

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626–650 of 5100