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

526–550 of 5100

CriticalFDA (Devices)·Z-2432-2025·2025-09-10
TruSeal DBL access systems recalled over air embolism risk without ventilation
Boston Scientific is recalling WATCHMAN TruSeal Access System DBL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2436-2025·2025-09-10
TruSteer transseptal access systems recalled over higher air embolism risk
Boston Scientific is recalling WATCHMAN TruSteer Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Product
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2447-2025·2025-09-10
Dexcom G7 iOS app recalled because sensor failure alerts do not appear
The Dexcom G7 CGM iOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.
Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2343-2025·2025-09-03
Insulin pumps recalled over malfunction that stops insulin delivery and alerts
Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.
Product
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2460-2025·2025-09-03
Reprocessed electrophysiology catheters recalled over small residual particulates in specific lots
Medline ReNewal reprocessed St. Jude Medical diagnostic electrophysiology catheters are recalled because specific lots may contain small residual particulates. The FDA classified the action as Class I.
Product
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2327-2025·2025-08-27
RELIANCE 4-FRONT defibrillation leads recalled over rising LVSI measurements and coil calcification
RELIANCE 4-FRONT defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils, which may lead to early lead replacement.
Product
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2325-2025·2025-08-27
ENDOTAK RELIANCE defibrillation leads recalled over coil calcification and rising LVSI
ENDOTAK RELIANCE G/SG transvenous defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.
Product
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2326-2025·2025-08-27
ENDOTAK RELIANCE leads with 4-SITE connector recalled over coil calcification
ENDOTAK RELIANCE G/SG defibrillation leads with the 4-SITE connector are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.
Product
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2328-2025·2025-08-27
Hamilton C6 ventilators recalled over circuit board defect interrupting ventilation
Hamilton C6 ventilators are recalled over a mechanical defect on a printed circuit board that may cause the device to fail at startup or interrupt ventilation during use. 1,040 systems are affected.
Product
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2273-2025·2025-08-20
Carotid stent delivery systems recalled over resistance during withdrawal after deployment
Certain batches of the Carotid WALLSTENT Monorail Endoprosthesis are being removed after complaints of greater than anticipated resistance withdrawing the delivery system. The most serious potential consequence is stroke.
Product
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2173-2025·2025-08-20
Infusion pumps recalled over underinfusion when flow rate more than doubles
Baxter is issuing an urgent correction for 36,705 Novum IQ large volume pumps because the pump may underinfuse when moving to a flow rate more than double the current one.
Product
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2181-2025·2025-08-20
Manual resuscitators recalled because blocked manometer port may disable pressure gauge
Ambu is recalling 87,156 SPUR II adult resuscitators because the manometer port may be blocked, leaving the manometer non-functional. The FDA classified the action as Class I.
Product
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2229-2025·2025-08-20
Non-continuous ventilators recalled over programming error causing incorrect device configuration
DreamStation Auto non-continuous ventilators are recalled because the devices may carry a programming error resulting in an incorrect device configuration. The FDA classified the action as Class I.
Product
DreamStation Auto. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2290-2025·2025-08-20
HeartMate mobile power unit cords recalled over locking feature that may disconnect
Abbott is recalling 53 HeartMate Mobile Power Unit AC power cords, model 107760, because a misaligned V-Lock may not engage and can allow an unintended disconnect. The FDA classified this as Class I.
Product
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device desi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2291-2025·2025-08-20
HeartMate mobile power unit cords may disconnect from a misaligned lock
HeartMate Mobile Power Units are being recalled because misaligned V-Lock features on the power cords prevent the locking mechanism engaging properly and may cause unintended disconnect. 604 units affected.
Product
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2228-2025·2025-08-20
DreamStation Auto BiPAP units may hold an incorrect device configuration
DreamStation Auto BiPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 8 units are affected.
Product
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2227-2025·2025-08-20
DreamStation Auto CPAP units may hold an incorrect device configuration
DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.
Product
DreamStation Auto CPAP. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2129-2025·2025-08-13
Plum Duo infusion system interface may become unresponsive during programming
The Plum Duo Infusion System is being recalled because two sequences of programming events and alarm interactions may cause the user interface to become unresponsive. 4,677 units are affected.
Product
Plum Duo Infusion System, List Number: 400020401
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2186-2025·2025-08-13
BritePro Solo mini laryngoscope handles may not illuminate as intended
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.
Product
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2182-2025·2025-08-13
BritePro Solo mini handles and blades may not illuminate as intended
BritePro Solo Single-Use Fiber Optic Mini Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.
Product
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2187-2025·2025-08-13
BritePro Solo fiber optic laryngoscope handles may not illuminate properly
BritePro Solo Single-Use Fiber Optic Laryngoscope Handles, REFs 040-310AU and 040-310U, are being recalled because the handles may not illuminate as intended.
Product
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2185-2025·2025-08-13
BritePro Solo stubby laryngoscope handles may not illuminate as intended
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.
Product
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2176-2025·2025-08-13
Microbore extension sets are labeled as having an air eliminating filter
Microbore Extension Sets with 0.2 Micron Filter are being recalled because the label indicates an air eliminating filter, but the filter fitted is not indicated for air removal. 34,825 US units affected.
Product
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Category
Medical Device
Distribution
32 states
SevereFDA (Devices)·Z-2184-2025·2025-08-13
BritePro Solo mini Miller blade handles may not illuminate as intended
BritePro Solo Mini with Pro Miller Blade Size 1.5 is being recalled because the laryngoscope handles may not illuminate as intended.
Product
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2180-2025·2025-08-13
BD Alaris pump infusion sets may perform outside established flow ranges
BD Alaris Pump Infusion Sets are being recalled because the pump module used with them may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.
Product
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pum
Category
Medical Device
Distribution
Distributed nationwide

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