The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

6451–6475 of 88183

  • 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-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-0534-2025·2025-09-03

    Everything bagel mix recalled because label omits sesame and other ingredients

    Baker's Authority Everything Bagel Mix in 1 lb and 5 lb bags is recalled because the label does not list its ingredients, including the major food allergen sesame. 197 units are affected.

    Product
    Baker's Authority Everything Bagel Mix; 5lb bag and 1lb bag; stored dry at room temperature; packaged in silver bag
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-2470-2025·2025-09-03

    Laparoscopy and pelviscopy packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems laparoscopy and pelviscopy procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,094 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
    Category
    Medical Device
    Distribution
    2 states
  • 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 (Devices)·Z-2464-2025·2025-09-03

    Heart and vascular packs recalled because sterilization rationale was not justified

    American Contract Systems heart, vascular and off-pump CABG packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 31,506 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316…
    Category
    Medical Device
    Distribution
    2 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 (Food)·H-0531-2025·2025-09-03

    Multigrain bread recalled because label omits sesame seed as allergen

    Breadman Bakery Multigrain bread, 24 oz, sold at seven Los Angeles retail locations, is recalled because the finished product label does not declare sesame seed. 52 loaves are affected.

    Product
    Breadman Bakery; Multigrain 24oz. Baked for Breaman-Melrose Bakery Inc. UPC# 8 6000947952 4
    Category
    Food
    Distribution
    1 state
  • 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 (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-2452-2025·2025-09-03

    Surgery trays recalled because they contain recalled tourniquet cuffs

    Medline General Surgery Trays are recalled because they contain recalled Stryker Color Cuff tourniquet cuffs whose flange may detach, compromising air pressure and risking tourniquet failure. 1,145 units are affected.

    Product
    The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0546-2025·2025-09-03

    Ice cream cartons recalled over undeclared almond, walnut and pecan

    Chocolate Chip Cookie Dough ice cream in half gallon cartons carrying a Moo-llennium Crunch lid is recalled for undeclared almond, walnut and pecan. 16,532 half gallons are affected.

    Product
    Chocolate Chip Cookie Dough ice cream cartons with a Moo-llennium Crunch lid. Packaging contains Moo-llennium crunch. Packaged in half gallon cartons (1.89 L)
    Category
    Food
    Distribution
    17 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…
    Category
    Food
    Distribution
    3 states
  • 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 (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
  • 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 (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-2424-2025·2025-09-03

    Canal filling stems recalled after unidentified substance found during retrospective evaluation

    ELEOS Segmental Stem Canal Filling straight slotted splined 2/3 plasma implants are recalled because an unidentified substance of unknown impact was found on devices. 15 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0548-2025·2025-09-03

    Bulk frozen shrimp recalled over insanitary conditions and possible cesium-137 contamination

    Frozen shrimp in bulk packaging is recalled because it was manufactured under insanitary conditions and may have been contaminated with Cesium-137. 17,214 cases across all brands are affected.

    Product
    Frozen shrimp in bulk packaging. 20 lbs (10 x 2 lbs blocks); 20 lbs (20 x 1 lbs blocks); 9 lbs case UPC# SH0176; SH0430; SH0320; SH0369; SH0370
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2445-2025·2025-09-03

    Phantom nose pad kits recalled because nickel content may cause allergic reaction

    Orascoptic Phantom Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 22 kits are affected.

    Product
    Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0533-2025·2025-09-03

    Three seed baking mix recalled because label omits sesame and other ingredients

    Baker's Authority Three Seed Mix in 5 lb bags is recalled because the label does not list ingredients, including the major food allergen sesame. Millet and flax are also undeclared. 78 units are affected.

    Product
    Baker's Authority Three Seed Mix; 5lb bag; stored dry at room temperature; packaged in silver bag
    Category
    Food
    Distribution
    17 states
  • 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
  • ModerateFDA (Devices)·Z-2437-2025·2025-09-03

    Hemodialysis delivery systems recalled over priming alarm requiring additional priming cycles

    PrisMax V2-US hemodialysis delivery systems are recalled because a low deaeration chamber level at post-priming tests may trigger alarm T2309, resulting in multiple additional priming cycles. 4,772 units are affected.

    Product
    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
    Category
    Medical Device
    Distribution
    0 states