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

4076–4100 of 39948

ModerateFDA (Devices)·Z-1646-2025·2025-04-30
Zimmer Biomet Ceramic Femoral Head Hip Prosthesis Labeling Recall
Zimmer, Inc. is recalling a ceramic femoral head hip prosthesis (Model 802602203) because product labeling lacks compatibility information for use with cobalt-chrome or stainless-steel femoral stems.
Product
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1666-2025·2025-04-30
Tempus Pro Patient Monitor software error when using video laryngoscope
Remote Diagnostic Technologies Ltd. is recalling Tempus Pro Patient Monitors due to a software issue that causes an error screen when a video laryngoscope is attached to the device.
Product
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)],
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1640-2025·2025-04-30
Merit Medical EsophyX Z+ Fastener Delivery Device Safety Update
Merit Medical is updating instructions for the EsophyX Z+ Fastener Delivery Device due to risks associated with device over-rotation and multiple fastener deployment.
Product
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1647-2025·2025-04-30
Zimmer Biomet Ceramic Hip Prosthesis Heads Lack Stem Compatibility Information
Zimmer, Inc. is recalling Zimmer Biomet Ceramic Head hip prostheses (Model 802802201, 22.2 mm diameter) because product labeling does not adequately provide compatibility information for use with cobalt-chrome or stainless-steel femoral stems.
Product
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1641-2025·2025-04-30
Merit Medical EsophyX Z+ Fastener Delivery Device Instructions Update
Merit Medical has updated instructions for the EsophyX Z+ fastener delivery device to provide additional information about risks associated with device over-rotation and multiple fastener deployment.
Product
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1664-2025·2025-04-30
Beckman Coulter DxI 9000 Access Immunoassay Analyzer communication loss
Beckman Coulter DxI 9000 Access Immunoassay Analyzer may lose connection to laboratory information systems, interrupting sample processing and delaying patient test results.
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1665-2025·2025-04-30
Alinity m System nucleic acid testing instruments recalled for liquid spillage
Abbott Molecular is recalling the Alinity m System due to a design flaw that may allow liquid waste or system solutions to spill beyond the instrument footprint into the user's walking path.
Product
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1659-2025·2025-04-30
Radiometer ABL90 Series Blood Analyzers May Unexpectedly Freeze
Radiometer ABL90 FLEX and ABL90 FLEX PLUS analyzers running Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may freeze unexpectedly during sample measurement, causing test results to be lost and delayed.
Product
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care
Category
Medical Device
Distribution
49 states
LowFDA (Devices)·Z-1658-2025·2025-04-30
Edge Biologicals Sterile Water incorrectly labeled product packaging
Edge Biologicals is recalling Sterile Water, 3mL (Product Number T-0780, Lot 01223) due to incorrect labeling on the product's outer packaging. The affected units were distributed nationwide in Pennsylvania.
Product
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparat
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1671-2025·2025-04-30
Straumann WB XL Anatomic Healing Abutment XC Dental Implants
Straumann USA LLC is recalling 1,786 units of WB XL Anatomic Healing Abutment XC endosseous dental implant abutments due to incorrect blister labeling. The product was distributed worldwide.
Product
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
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-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-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-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-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-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-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
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-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-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-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-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-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-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

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4076–4100 of 39948