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.

151–175 of 6113

  • SevereCPSC·26493·2026-05-14

    Cosyland Children's Tower Stools Recalled for Entrapment and Fall Hazards

    Cosyland Children's Tower Stools can collapse, tip over, or trap a child's torso through front and back openings, posing risks of serious injury and death. The firm is aware of 25 reports of stability issues and falls, with eight injuries including a fractured arm.

    Product
    Cosyland Children's Tower Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26482·2026-05-14

    Can-Am Outlander Pro and Max Pro All-Terrain Vehicles Speed Limiter Malfunction

    BRP US Inc. recalls about 2,820 Can-Am Outlander Pro and Max Pro ATVs with defective Speed Limiter Mode that can cause unexpected speed and acceleration, posing a risk of serious injury or death from crashes.

    Product
    Can-Am Outlander Pro and Max Pro All-Terrain Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26481·2026-05-14

    Tiyol Pull String Teething Toys Recalled for Choking Hazard Risk

    Tiyol Pull String Teething Toys sold on Amazon are recalled due to oversized silicone strings that can lodge in the throat, posing a choking hazard. CPSC is aware of 11 choking incidents.

    Product
    Tiyol Pull String Teething Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26483·2026-05-14

    Misco Sports Badminton Toy Sets Recalled Due to Battery Ingestion Risk

    Missry Associates is recalling Misco Sports Badminton Toy Sets because the shuttlecocks contain button cell batteries that children can easily access and swallow, potentially causing serious internal injuries or death.

    Product
    Misco Sports Badminton Toy Sets Red/Blue MT2383
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26494·2026-05-14

    Electric Start Pressure Washers Recalled for Carbon Monoxide Hazard

    Generac and DR Power electric start pressure washers are recalled because the electronic start/stop button can malfunction and self-start the unit, creating a risk of serious injury or death from carbon monoxide poisoning in confined spaces. No injuries have been reported.

    Product
    Electric Start Pressure Washers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26485·2026-05-14

    Agio Menlo Woven Patio Swings Recalled Due to Fall Hazard Risk

    World Bright International Limited recalls Agio Menlo Woven Patio Swings (Model 1934256) sold at Costco because the swing seat can detach during use, risking serious injury or death. Eight injuries have been reported.

    Product
    Agio Menlo Woven Patio Swings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1979-2026·2026-05-13

    Halyard VA Detroit Cath Lab Pack Kit Syringe Adaptor Disconnection Risk

    Halyard VA Detroit Cath Lab Pack kits (Model VMCD029) are being recalled due to a potential risk that the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0519-2026·2026-05-13

    Octreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance

    Teva Pharmaceuticals USA, Inc. is recalling 2,200 kits of Octreotide Acetate for Injectable Suspension (30 mg) due to quality system deficiencies that affect sterility assurance. The recall affects all lots nationwide.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1972-2026·2026-05-13

    Halyard Cardiac Catheterization Tray Kits Recalled for Connection Risk

    AVID Medical is recalling Halyard CARDIAC CATH TRAY SHANDS JAX kits due to a defect in the Medline syringe rotating adaptor that may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1978-2026·2026-05-13

    Halyard SAMMC Angiography Kit syringe rotating adapter unwinding recall

    Halyard SAMMC ANGIOGRAPHY kits (Model SAMM066-15) are recalled because the Medline syringe rotating adapter may unwind during use, causing a loose or disconnected connection between the syringe and manifold. 2,392 kits were distributed across US states including FL, IL, MO, MS, NC, NE, and TX.

    Product
    Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0523-2026·2026-05-13

    Naproxen Oral Suspension Recalled for Lead and Lithium Contamination

    Acella Pharmaceuticals is recalling Naproxen oral suspension due to the presence of lead and lithium above specification levels. The recall affects 6,336 bottles distributed nationwide.

    Product
    NAPROXEN — NAPROXEN (NAPROXEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0524-2026·2026-05-13

    TPN Bag Recalled for Missing Insulin Formulation Error

    Central Admixture Pharmacy Services is recalling a patient-specific TPN bag because it did not contain insulin as listed on the label. Patients relying on this product for the labeled insulin dosage may face serious health risks.

    Product
    TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0540-2026·2026-05-13

    Lactated Ringers Injection Recalled for Particulate Matter Contamination

    B. Braun Medical Inc. is recalling Lactated Ringer's Injection USP (1000 mL containers) due to the presence of particulate matter. The recall affects 95,412 containers distributed nationwide.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2091-2026·2026-05-13

    Medline Convenience Kits Recalled for Sterilization Calibration Issues

    Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were distributed nationwide.

    Product
    Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1973-2026·2026-05-13

    Halyard CATH LAB Kit Recalled for Syringe Adapter Disconnection Risk

    AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75AM) because the syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard CATH LAB kit. Model Number: SACL75AM.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2106-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization equipment calibration issues

    Medline Industries is recalling four Convenience Kit models (892 units) nationwide because sterilization and packaging equipment calibration issues may have compromised the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2108-2026·2026-05-13

    Medline Labor and Delivery Kits Recalled for Sterilization Calibration Issues

    Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.

    Product
    Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) KIT LABOR & DELIVERY CERCL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1976-2026·2026-05-13

    Halyard NEURO IR PERIPHERAL kit syringe adapter may disconnect

    AVID Medical is recalling the Halyard NEURO IR PERIPHERAL (PS 64405) kit because the Medline syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2097-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterilization issues

    Medline Industries is recalling multiple convenience kit models due to calibration issues with equipment used to sterilize and package the devices, which could affect sterility assurance levels.

    Product
    See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2114-2026·2026-05-13

    Medline Surgical Convenience Kits recalled for sterilization calibration defect

    Medline Industries is recalling multiple surgical convenience kits because equipment used to sterilize and package the devices had calibration issues that may have affected sterility assurance. The devices were processed through validated sterilization cycles but the calibration problems could impact their sterility.

    Product
    See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1855-2026·2026-05-13

    Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect

    Intuitive Surgical is recalling Intuitive 8 mm SureForm 30 Gray Reloads (Reference Numbers 48230M-05 and 48230M-06) because they may produce an incomplete staple line during curved-tipped stapler operations.

    Product
    Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1936-2026·2026-05-13

    Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands

    Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because marker bands may crack or break, which could lead to device fragmentation, prolonged procedures, vessel injury, and in worst-case scenarios, life-threatening harm or death.

    Product
    Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1974-2026·2026-05-13

    Halyard CATH LAB Kit Due to Syringe Adapter Disconnection Risk

    AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75-01) due to risk that a Medline syringe rotating adaptor may unwind during use, causing loose or complete disconnection between the syringe and manifold.

    Product
    Halyard CATH LAB kit. Model Number: SACL75-01.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·H-0764-2026·2026-05-13

    Raw Farm Raw Cheddar Cheese Recalled Due to E. coli O157:H7 Outbreak

    Raw Farm Raw Cheddar Simply Shredded cheese is recalled for E. coli O157:H7 contamination in a multi-state outbreak. Affected batches include code 20260212 and all prior batches with best-by date of 5/13/2026 or earlier.

    Product
    RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENNET, CULTURES, KOSHER SEA SALT Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 8
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0517-2026·2026-05-13

    PurPrep Povidone-Iodine and Isopropyl Alcohol Solution Recalled for Sterility Assurance

    CareFusion 213, LLC is recalling PurPrep sterile topical solution due to lack of assurance of sterility and potential product contamination. The affected product is a povidone-iodine and isopropyl alcohol solution distributed nationwide.

    Product
    PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide