The Recall Desk

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.

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676–700 of 5027

  • SevereFDA (Devices)·Z-1644-2025·2025-04-30

    Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk

    Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
    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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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