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

676–700 of 5100

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-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-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-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-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-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-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-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-1456-2025·2025-04-16
Medline medical procedure kits with Medtronic Aortic Root Cannula recalled
Medline Industries is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to a Class I defect. The kits were distributed to healthcare facilities in nine states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1457-2025·2025-04-16
Medline Medical Procedure Kits with Aortic Root Cannula Recalled
Medline is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to potential excess material in the male lures on the cannula. The recall affects 468 units distributed across nine US states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1458-2025·2025-04-16
Medline Heart Basin Procedure Kits with Aortic Cannula Recalled
Medline medical procedure kits containing Medtronic Aortic Root Cannula are recalled due to potential excess material in the male luer connectors on the aortic cannula.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1512-2025·2025-04-16
Hippo 072 Aspiration System recalled for distal tip detachment risk
Qapel Medical Inc. is recalling the Hippo 072 Aspiration System and related components because the aspiration catheter distal tip may detach, potentially causing vessel rupture or vasospasm.
Product
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
Category
Medical Device
Distribution
29 states
SevereFDA (Devices)·Z-1459-2025·2025-04-16
Medline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
Medline medical procedure kits containing a Medtronic Aortic Root Cannula are being recalled due to potential excess material in the male lures on the aortic cannula. The kits were distributed in nine US states.
Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1505-2025·2025-04-16
Medline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
Medline is recalling multiple medical convenience kits distributed in California that contain defective intubation endotracheal tubes previously recalled by the manufacturer Smiths Medical. The affected kits are used for neonatal and pediatric resuscitation and intubation procedures.
Product
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1543-2025·2025-04-16
Stimulation RC Clinician Programmer Application Software Communication Issue
The Stimulation RC Clinician Programmer Application (Model A71400) has a software issue that can permanently disable communication with certain implantable neurostimulators when a specific intraoperative programming sequence is used. Approximately 1,493 devices were distributed worldwide.
Product
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1496-2025·2025-04-09
Anesthesia Circuit Kit Flex 2 recalled due to breathing hose crack risk
Draeger's Anesthesia Circuit Kit Flex 2 is recalled because of the potential for cracks to form in the breathing circuit hose. No injuries have been reported.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1498-2025·2025-04-09
Anesthesia Circuit Kit Flex (P)2 recalled for potential breathing hose cracks
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex (P)2 due to the potential for cracks to form in the breathing circuit hose. This FDA Class I recall affects approximately 9,250 units distributed domestically and internationally.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is inten
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1493-2025·2025-04-09
VentStar Flex 220 Breathing Circuit Recalled for Potential Hose Cracks
Draeger, Inc. is recalling 65,150 units of the VentStar Flex 220 breathing circuit due to the potential for cracks to form in the hose. A crack could affect gas delivery during anesthesia or ventilation procedures.
Product
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1497-2025·2025-04-09
Anesthesia Circuit Kit Flex 6 Recalled for Potential Breathing Hose Cracks
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex 6 (Model MP02744) due to potential cracks forming in the breathing circuit hose. Approximately 293,660 units were distributed nationwide and internationally.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1495-2025·2025-04-09
Draeger Anesthesia Circuit Kit Flex 1 recalled for potential hose cracks
Draeger, Inc. is recalling Anesthesia Circuit Kit Flex 1 devices nationwide and internationally due to potential cracks in the breathing circuit hose that conducts anesthesia gases.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1494-2025·2025-04-09
Draeger ID Circuit Flex 220 breathing circuit hoses subject to cracking
Draeger's ID Circuit Flex 220 breathing circuit for anesthesia machines may develop cracks in the hose. The recall affects 3,325 units distributed nationwide and internationally.
Product
Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1499-2025·2025-04-09
Anesthesia Circuit Kit Flex EPA recalled due to breathing hose cracking
Draeger is recalling the Anesthesia Circuit Kit Flex EPA due to the potential for cracks to form in the breathing circuit hose. Approximately 13,620 units have been distributed domestically and internationally. Users should discontinue use of affected units immediately.
Product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intend
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0301-2025·2025-04-02
SinuCleanse Neti Pot Nasal Wash System Recalled for Bacterial Contamination
Ascent Consumer Products Inc. is recalling SinuCleanse Soft Tip Neti Pot Nasal Wash System due to bacterial contamination with Staphylococcus aureus. Consumers should stop using this product immediately.
Product
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1390-2025·2025-04-02
Shiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk
Covidien is recalling 780 Shiley Adult Flexible Tracheostomy Tubes because the flange may disconnect from the outer cannula, potentially causing respiratory failure, aspiration, or death.
Product
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Category
Medical Device
Distribution
0 states

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