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

2676–2700 of 27375

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-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-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-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
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-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-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-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
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-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-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
SevereFDA (Devices)·Z-1699-2025·2025-05-07
Distal Femoral Augment medical device recall for defective screw
Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.
Product
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
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-1702-2025·2025-05-07
Tibial Augment devices recalled for missing screw thread
Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.
Product
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
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-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-1627-2025·2025-05-07
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 620 A1, Model/REF Number 1012-9620-200. 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
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-1704-2025·2025-05-07
Enhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator
Medtronic Enhanced Verify Evaluation Handsets (CFN HH90130FA) may fail to communicate with neurostimulators due to faster processing speed, causing therapy to stop and patients to experience return of underlying symptoms.
Product
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1631-2025·2025-05-07
GE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall
Certain GE Healthcare Carestation anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Affected systems can still be used safely in Pressure Control Ventilation or Manual ventilation modes.
Product
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. 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
SevereFDA (Devices)·Z-1696-2025·2025-05-07
Quantum Informatics VISION LIVE VUE Patient Monitor Recalled Without FDA Clearance
Spectrum Medical Ltd. is recalling the Quantum Informatics VISION / LIVE VUE patient monitoring software because it was marketed without required FDA clearance or approval.
Product
Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clini
Category
Medical Device
Distribution
38 states
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

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