The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

2026–2050 of 29084

  • 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 (Food)·F-0706-2025·2025-04-23

    Marketside Brand Celery Sticks Recalled for Listeria Monocytogenes

    Marketside brand celery sticks (1.6 oz) have been recalled due to Listeria monocytogenes contamination. Duda Farm Fresh Foods, Inc. is recalling approximately 1,587 cases distributed nationwide.

    Product
    Marketside brand celery stick. Net wt. 1.6 OZ. (45g); Rear panel: 1 serving per container; Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 UPC# 6 81131 16151 0
    Category
    Food
    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-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-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-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 (Drugs)·D-0365-2025·2025-04-23

    Levetiracetam Injection Label Mismatch Nationwide Recall

    Dr. Reddy's Laboratories is recalling Levetiracetam 0.75% Sodium Chloride Injection due to a labeling discrepancy where the infusion bag is incorrectly labeled as 0.82% Sodium Chloride 500 mg/100 mL instead of the correct 0.75% Sodium Chloride 1,000 mg/100 mL.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM INJECTION)
    Category
    Drug
    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
  • SevereNHTSA·25V266000·2025-04-22

    IC school bus driver seat belt anchor bolts may come loose

    International is recalling certain 2025-2026 IC CESB and 2025 EVSB school buses because the driver's seat belt anchor bolt may come loose, so the belt may not restrain the driver in a crash.

    Product
    IC BUS — IC BUS CESB, EVSB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V268000·2025-04-22

    Utilimaster Aeromaster Recall for Improperly Tightened Seat Fasteners

    Shyft Group is recalling 2022-2025 Utilimaster Aeromaster vehicles because suspension seat mounting fasteners may be improperly tightened, increasing injury risk in a crash.

    Product
    UTILIMASTER — UTILIMASTER AEROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V262000·2025-04-21

    Motiv Recalls 2020 F-59 School Buses Due to Power Bracket Defect

    Motiv Power Systems is recalling 2020 F-59 BEV chassis school buses because a support bracket may break, causing an electrical short and loss of drive power.

    Product
    MOTIV — MOTIV F-59 BEV CHASSIS SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V261000·2025-04-18

    Motiv Recalls F-53 and F-59 Chassis Due to Bracket Failure Risk

    Motiv Power Systems is recalling 2019-2022 F-53 and F-59 chassis vehicles because a support bracket may break, causing an electrical short and loss of drive power.

    Product
    MOTIV — MOTIV F-53 BEV CHASSIS, F-59 BEV CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V263000·2025-04-18

    Motorhome slide-room floor may not retain seat belts in a crash

    Forest River is recalling certain 2025 East to West Bravado BRC33DSF motorhomes because the slide-room floor may detach in the open position and may not properly retain the seat belts during a crash.

    Product
    EAST TO WEST — EAST TO WEST BRAVADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V257000·2025-04-17

    Volvo truck idler gear can detach from the engine causing stall

    Volvo Trucks is recalling certain 2022-2025 VN and 2025 New VN trucks because improperly tightened idler gear bracket fasteners may allow the idler gear to detach from the engine.

    Product
    VOLVO — VOLVO VNL (4), VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V250000·2025-04-17

    Altec Recalls 2014-2016 AT200A Aerial Devices Due to Frame Cracks

    Altec is recalling 2014-2016 AT200A aerial devices because cracks in the mounting frame legs may cause the side plate to break, increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V256000·2025-04-17

    Mack Recalls 2025 Anthem Trucks Due to Engine Gear Bracket Defect

    Mack Trucks is recalling 2025 Anthem vehicles because improperly tightened idler gear bracket fasteners may allow the gear to detach, potentially causing an engine stall and increasing crash risk.

    Product
    MACK — MACK ANTHEM (AN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25229·2025-04-17

    Glow Sticks and Glasses Party Pack Toys Recalled for Ingestion Hazard

    Leetous glow sticks and glasses party packs are recalled because button cell batteries can be easily removed from compartments and swallowed by children, causing serious injury or death. About 6,300 units were sold on Amazon.com from October 2024 through February 2025.

    Product
    Glow Sticks and Glasses Party Pack Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25228·2025-04-17

    COMEONROA Infant Swings Recalled Due to Suffocation Risk

    COMEONROA infant swings are being recalled because they pose a suffocation risk—they were marketed for sleep but exceed the 10-degree incline limit set by the Safe Sleep for Babies Act. No injuries have been reported.

    Product
    COMEONROA Infant Swings
    Category
    Consumer Product
    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