The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

2426–2450 of 52932

  • HighCPSC·26171·2026-01-08

    NFSVLB baby bath seats recalled over tip over and entrapment hazards

    About 1,430 NFSVLB baby bath seats are being recalled because they are unstable, can tip over, and have leg openings that allow a child's torso to become entrapped.

    Product
    NFSVLB Baby Bath Seats (blue)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0391-2026·2026-01-07

    Peanut butter flake candy bars recalled over foreign material

    Tom Bumble is recalling approximately 6,500 units of Nutty Peanut Butter Flake Candy with Peanut & Chocolate over foreign material.

    Product
    Tom Bumble Nutty Peanut Butter Flake Candy with Peanut & Chocolate GF V. Product is shelf stable, gold foil wrapping with paper label and cardboard outer box in some cases. Oregon Bark 2630 NE Sandy Blvd. Portland, Oregon 97232 2 Bars Boxes marked 50/50 or Nutty 4 Bars Boxes
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0244-2026·2026-01-07

    Wegovy 0.5 mg pens recalled after hair was found in a syringe

    Novo Nordisk is recalling Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL prefilled pens, over the presence of particulate matter after hair was found in a prefilled syringe.

    Product
    Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2026·2026-01-07

    Ultrasound probe covers recalled over defects that may cause contamination during use

    Sheathing Technologies is recalling 12 units of Sheathes3D vaginal and rectal ultrasound probe covers because product defects may result in contamination during use, posing an infection risk.

    Product
    Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0243-2026·2026-01-07

    ChloraPrep triple swabsticks recalled over lack of assurance of sterility

    CareFusion 213 is recalling 106,400 units of BD ChloraPrep Triple Swabsticks over a lack of assurance of sterility.

    Product
    CHLORAPREP SWABSTICK — CHLORAPREP SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0245-2026·2026-01-07

    Wegovy prefilled pens recalled after hair was found in a syringe

    Novo Nordisk is recalling Wegovy (semaglutide) Injection, 1 mg/0.5 mL prefilled pens, over the presence of particulate matter after hair was found in a prefilled syringe.

    Product
    Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·26V004000·2026-01-06

    Blue Bird Recalls 2026 Electric Transit Buses with Wheelchair Restraint Defect

    Blue Bird is recalling 2026 Vision and All American electric transit buses because wheelchair restraints may fail to lock, increasing injury risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS (ELECTRIC), VISION TRANSIT BUS (ELECTRIC)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2026·2025-12-31

    Dialysis concentrate 100325 recalled because safety and efficacy cannot be assured

    Diasol is recalling 74,400 gallons of liquid concentrate for bicarbonate dialysis, product 100325-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2026·2025-12-31

    Femoral nails, 300 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815509300, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2026·2025-12-31

    Bicarbonate reagent recalled over falsely high results from LDH interference

    Beckman Coulter is recalling 36,981 bicarbonate reagents because they may generate falsely high bicarbonate results due to interference with lactate dehydrogenase in the sample.

    Product
    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2026·2025-12-31

    Infusion software recalled over concentration limits with insufficient decimal precision

    ICU Medical is recalling LifeShield Drug Library Management software because Concentration Limits can only be defined to one decimal place instead of three, which may result in over- or under-delivery.

    Product
    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0965-2026·2025-12-31

    Infusion drug library software recalled over a failing change review option

    ICU Medical is recalling LifeShield Drug Library Management software because the Change Summary review option stops working for migrated libraries, which may lead to dosing or setup errors.

    Product
    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2026·2025-12-31

    Femoral nails, 320 mm left trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815609320, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0968-2026·2025-12-31

    Femoral nails, 340 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509340, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2026·2025-12-31

    Medication dispensing cabinets recalled after a firmware update caused drawer failures

    CareFusion 303 is recalling 53,669 BD Pyxis automated dispensing cabinet units after a drawer firmware update caused a duplicate address error and drawer failure.

    Product
    BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2026·2025-12-31

    Femoral nails, 380 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815509380, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2026·2025-12-31

    Dialysis concentrate 100220 recalled because safety and efficacy cannot be assured

    Diasol is recalling 4400 gallons of liquid concentrate for bicarbonate dialysis, product 100220-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2026·2025-12-31

    Femoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609360, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2026·2025-12-31

    Femoral nails, 420 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509420, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide