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.

3701–3725 of 52939

  • HighFDA (Devices)·Z-2341-2025·2025-09-03

    OEC 9800 C-arm systems recalled over missing collimator cover lead tape

    GE HealthCare OEC 9800 C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.

    Product
    GE HealthCare OEC 9800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2025·2025-09-03

    Custom loupes with Dragonfly frames recalled over nickel nose pad allergy risk

    Orascoptic custom loupes with Dragonfly frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 15,245 units are affected.

    Product
    Orascoptic Superior Visualization Custom loupes with Dragonfly frames
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2025·2025-09-03

    C-arm imaging systems recalled over missing lead tape in collimator covers

    GE HealthCare OEC 9800 and OEC 9900 Elite C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.

    Product
    GE HealthCare OEC 9900 Elite C-arm Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2025·2025-09-03

    Phantom Essential loupe kits recalled because nickel nose pads may cause allergy

    Orascoptic Phantom Essential Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 74 kits are affected.

    Product
    Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2025·2025-09-03

    Hip and knee procedure packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2468-2025·2025-09-03

    Craniotomy and shunt packs recalled over unjustified sterilization of certain components

    American Contract Systems craniotomy and shunt procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 204 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0605-2025·2025-09-03

    Alcohol prep pads recalled for isopropyl alcohol below labeled concentration

    Rite Aid Pharmacy first aid alcohol prep pads are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 984,000 pads.

    Product
    ALCOHOL — ALCOHOL (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0600-2025·2025-09-03

    Medline alcohol prep pads recalled for alcohol below labeled concentration

    Medline Alcohol Prep Pads, 70% isopropyl alcohol, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 6,669,874 swabs.

    Product
    MEDLINE ALCOHOL PREP — MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0537-2025·2025-09-03

    Friendly's ice cream recalled over undeclared wheat and soy from mismatched cartons

    Friendly's 48 fl oz cartons labeled Vanilla Bean carry a Cookies and Cream lid and contain Cookies and Cream, leaving wheat and soy undeclared. 54 cases are affected.

    Product
    Carton Label: "Friendly's Vanilla Bean"; 48 fl. oz. Lid Label: "Friendly's Cookies and Cream" Product in carton is Cookies and Cream.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·H-0549-2025·2025-09-03

    Raw frozen shrimp recalled over possible contamination with cesium-137

    Great Value and Sea Best branded raw frozen shrimp in bulk master cartons, product of Indonesia, is recalled because the product may be contaminated with Cesium-137. 33,164 pounds are affected.

    Product
    Great Value branded and Sea Best branded raw frozen shrimp in bulk packaging, master cartons. Master carton case is 20 lbs (10 x 2lbs retail bags), and 18 lbs (12 x 1.5lbs retail bags) and (10x1lb retail bags), Product of Indonesia, Keep Frozen, Distributed by Beaver Street Fish
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·H-0535-2025·2025-09-03

    Graham cracker meal recalled because label lists no ingredients or allergens

    Baker's Authority Graham Cracker Meal in 5 lb bags is recalled because the label does not list its ingredients, including the major food allergens wheat and soy. 70 units are affected.

    Product
    Baker's Authority Graham Cracker Meal; 5lb bag; stored dry at room temperature; packaged in silver bag
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-2442-2025·2025-09-03

    Dragonfly Essentials loupe kits recalled because nickel nose pads may cause allergy

    Orascoptic Dragonfly Essentials Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 32 kits are affected.

    Product
    Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2025·2025-09-03

    Hysterectomy procedure packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems robotic and vaginal hysterectomy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 50 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2425-2025·2025-09-03

    Limb salvage stem extensions recalled after unidentified substance found on devices

    ELEOS Segmental Limb Salvage System straight splined slotted stem extensions are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 554 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0601-2025·2025-09-03

    CURAD alcohol prep pads recalled for isopropyl alcohol below labeled strength

    CURAD Sterile Alcohol Prep Pads, medium 2-ply, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 1,639,996 pads.

    Product
    CURAD ALCOHOL PREP PADS — CURAD ALCOHOL PREP PADS (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2025·2025-09-03

    Surgical kits recalled because Foley tray inserts carry incorrect product information

    Medline kits containing BD SureStep Foley Tray Systems are recalled because the trays include incorrect product information insert sheets. Four units were distributed, all from the LAVH MINOR SKU.

    Product
    Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2441-2025·2025-09-03

    Custom loupes with Phantom frames recalled over nickel nose pad allergy risk

    Orascoptic custom loupes configured with Phantom frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 10,611 units are affected.

    Product
    Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25E054000·2025-09-03

    Magna Recalls Rearview Cameras on Ford and Chrysler Vehicles

    Magna International is recalling rearview cameras installed on certain Ford and Chrysler vehicles because they may display a blank or inverted image, increasing crash risk.

    Product
    BACK OVER PREVENTION: SENSING SYSTEM: CAMERA recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0599-2025·2025-09-03

    Lisdexamfetamine 40 mg bottles recalled after being filled with 30 mg capsules

    Lisdexamfetamine Dimesylate Capsules 40 mg, lot 25280726A, distributed by Lannett, are recalled because a bottle labeled 40 mg contained 30 mg capsules. 8,544 bottles are affected.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0603-2025·2025-09-03

    H-E-B alcohol pads recalled for isopropyl alcohol below labeled concentration

    H-E-B inControl Sterile Alcohol Pads, 100 per container, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 300,000 pads.

    Product
    INCONTROL ALCOHOL — INCONTROL ALCOHOL (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2025·2025-09-03

    Sucralfate tablets recalled after bankruptcy left quality program unmonitored

    Sucralfate Tablets USP 1 gram from American Health Packaging are recalled because the firm's Chapter 11 filing left it unable to monitor its quality program. 26,992 blister packs are affected.

    Product
    Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
    Category
    Drug
    Distribution
    Distributed nationwide