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

2751–2775 of 27346

HighFDA (Devices)·Z-1652-2025·2025-04-30
CELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect
Abbott's CELL-DYN Ruby hematology analyzer may accept expired reagents without alerting the operator, potentially allowing use of expired materials in patient testing.
Product
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1656-2025·2025-04-30
CELL-DYN Ruby hematology analyzer medical device recall
Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because expired reagents may be used without user notification when scanned or manually entered into the system, contrary to manufacturer guidelines.
Product
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1639-2025·2025-04-30
BD PYXIS MEDBANK Automated Dispensing Cabinet Software Defect
CareFusion's BD PYXIS MEDBANK and MEDFLEX automated dispensing cabinets may experience a software issue during bin restocking that doubles bin quantities, potentially delaying access to medications and supplies.
Product
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1670-2025·2025-04-30
Rover Mobile X-ray System internal fastening mechanism failure risk
Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Five units distributed in New Jersey, Washington, and Puerto Rico are affected.
Product
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagno
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1657-2025·2025-04-30
Globus Medical MAGEC 2 Rod recalled for incorrect outer diameter assembly
Globus Medical is recalling MAGEC 2 Rod model MC2-5090S devices because certain units were assembled with a 5.5mm outer diameter rod instead of the required 5.0mm specification.
Product
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1651-2025·2025-04-30
Stryker Latitude EV Humeral Revision Stem Trial with Incorrect Marking
A specific lot of Stryker Latitude Humeral Trial Stems has incorrect laser marking and color indicator, potentially resulting in implantation of the wrong device size and orientation.
Product
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1669-2025·2025-04-30
Rover Mobile X-ray System internal fastening mechanism failure potential
Micro-X Ltd. is recalling Rover Mobile X-ray System units (models MXU-RV71, MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Affected units were distributed in New Jersey, Washington, and Puerto Rico.
Product
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring med
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1663-2025·2025-04-30
Skytron Freedom Monitor Mount Hardware Recall for Inadequate Thread Engagement
The mounting hardware supplied with the Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount does not provide adequate thread engagement to support the weight of the frame and monitor, creating a risk of hardware failure and separation.
Product
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1533-2025·2025-04-23
AutoPulse NXT Resuscitation System may fail to provide chest compressions
ZOLL Circulation, Inc. is recalling the AutoPulse NXT Resuscitation System Model 200 because the device may not provide adequate chest compressions or may stop compressions due to an error code FC1060.
Product
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, bat
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-1522-2025·2025-04-23
Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 210, 10 F Elbow) for neonates and pediatric patients due to lack of sterility assurance. Approximately 4,000 units were distributed worldwide.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1524-2025·2025-04-23
Ballard Closed Suction Catheters recalled for sterility assurance failure
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 220135) due to lack of sterility assurance. The recall affects 9,020 units distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1570-2025·2025-04-23
HeartMate Mobile Power Unit electrical malfunction may cause loss of power
Thoratec LLC is recalling HeartMate Mobile Power Units due to an electrical component defect that may prevent the unit from turning on, cause unprompted shut down, or trigger false alarms. If power is lost and not switched to rechargeable batteries within 15 minutes, the connected pump may lose power.
Product
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1558-2025·2025-04-23
Welch Allyn Connex Vital Signs Monitors with Unapproved Batteries
Baxter Healthcare is recalling Welch Allyn Connex Vital Signs Monitors because some units experienced battery-related fires caused by unapproved third-party after-market batteries.
Product
Welch Allyn Connex Vital Signs Monitor (CVSM):
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1526-2025·2025-04-23
Ballard Closed Suction Catheters recalled due to sterility assurance failure
Avanos Medical is recalling 1,420 units of Ballard Closed Suction Catheters (Model 2271418-5) due to lack of sterility assurance. The affected product was distributed worldwide, including across the US and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1528-2025·2025-04-23
Ballard Closed Suction Catheters recalled for sterility assurance defect
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 22714183-5) due to lack of sterility assurance. The affected lot was distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1519-2025·2025-04-23
t:slim X2 Insulin Pump Software Defect Affecting Glucose Delivery
Tandem Diabetes Care is recalling 63 units of the t:slim X2 Insulin Pump with software version 7.9 due to a defect that can cause incorrect insulin delivery. The defect may lead to dangerous blood sugar levels when glucose monitoring loses connection.
Product
t:slim X2 Insulin Pump with Interoperable Technology
Category
Medical Device
Distribution
29 states
SevereFDA (Devices)·Z-1559-2025·2025-04-23
Welch Allyn CONNEX Power Management Stand Battery Fire Risk
Baxter Healthcare is recalling the Welch Allyn CONNEX Accessory Power Management Stand due to reports of battery-related fires caused by unapproved third-party batteries.
Product
Welch Allyn CONNEX Accessory Power Management Stand:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1560-2025·2025-04-23
Welch Allyn CP150 Electrocardiograph Recall Due to Battery Fire Risk
Baxter Healthcare is recalling Welch Allyn CP150 Electrocardiographs worldwide due to reports of battery-related fires. The fires occurred when devices used non-approved, third-party aftermarket batteries.
Product
Welch Allyn CP150 Electrocardiograph:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1525-2025·2025-04-23
Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 2210-5) because they lack adequate sterility assurance. The recall affects approximately 2,080 units distributed worldwide, including across most US states and several countries.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1584-2025·2025-04-23
Cerene Cryotherapy Device recalled for defective gasket seal
Channel Medsystems is recalling the Cerene Cryotherapy Device (Model FGS-7000) due to a defective evaporator gasket that may fail to seal, causing liquid nitrous oxide to leak during or after treatment.
Product
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to r
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1521-2025·2025-04-23
Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 198, 8 F, Y-Adapter) for neonates and pediatrics due to lack of sterility assurance. The recall affects 1,980 units distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1527-2025·2025-04-23
Ballard Closed Suction Catheters lack sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. The recall affects 1,040 units distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1523-2025·2025-04-23
Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 20083) due to lack of sterility assurance. The company has distributed approximately 9,960 units worldwide.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1507-2025·2025-04-23
BD 4 Fr Single-Lumen PowerPICC Catheters Recall Risk of Leaks
Bard Access Systems is recalling BD 4 Fr Single-Lumen PowerPICC Catheters worldwide because tubing material may exceed specifications, causing leaks and potentially serious complications including infection and air embolism.
Product
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1520-2025·2025-04-23
Tandem Mobi Insulin Pump Software Defect Risks Incorrect Insulin Delivery
Tandem Diabetes Care is recalling Tandem Mobi Insulin Pumps with software version 7.9 due to a defect that can cause incorrect insulin delivery when glucose data gaps occur, potentially leading to severe high or low blood sugar.
Product
Tandem Mobi Insulin Pump with Interoperable Technology
Category
Medical Device
Distribution
29 states

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2751–2775 of 27346