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.

6376–6400 of 88183

  • HighFDA (Devices)·Z-2521-2025·2025-09-10

    Tumor profiling assay recalled after incorrect result gave wrong therapy recommendation

    One MI Cancer Seek tumor mutational profiling assay is recalled because an incorrect test result was provided that indicated the incorrect drug therapy recommendation.

    Product
    MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2025·2025-09-10

    NRFit yellow cassette reservoirs recalled over weakened medication bag welds

    Smiths Medical NRFit CADD Yellow Medication Cassette Reservoirs, 100 mL, product code 21-7600-24, may have weakened medication bag welds that could allow leakage. 15,546 units are affected.

    Product
    Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2506-2025·2025-09-10

    MediHoney paste tubes recalled over packaging failures breaching the sterile barrier

    MediHoney Paste tubes, catalog numbers 31515 and 31535, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 141,620 units are affected.

    Product
    Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0550-2025·2025-09-10

    HEB blueberry flavored yogurt pretzels recalled over undeclared wheat allergen

    HEB 8 oz Blueberry Flavored Yogurt Pretzels, lots 080226 and 080326, are recalled for an undeclared wheat allergen. The recall covers 468 cases of 12 packages each, distributed in Texas.

    Product
    Product Name: Blueberry Pretzels " Brand Name: HEB " Description: 8oz HEB Blueberry Flavored Yogurt Pretzels " UPC Codes: 9787011400 " Lot Numbers: 080226, 080326 " Best By / Use By Dates: 080226 & 080326 " Package Size: 8oz " Establishment Number: 008046575
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2520-2025·2025-09-10

    Surgical drape packs recalled because open seals may compromise sterility

    Orthopedic Pack model 88041-12 and Universal Pack model 77165-06 are recalled because the surgical drape packs may have open seals that could compromise sterility. 1,316 units are affected.

    Product
    Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0554-2025·2025-09-10

    Golden raisins recalled because sulfites are undeclared on the package

    Nirwana Foods Golden Raisins, 28 oz clear bags, lot 24/351-2410, are recalled because sulfites are undeclared. The product was distributed in New Jersey and New York.

    Product
    Nirwana Foods, Golden Raisin, 28 oz (794g), Net Wt. 1.75 LBS, Clear Bags, 20 bags Per Case, keep at room Temperature
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2508-2025·2025-09-10

    MediHoney hydrogel sheet dressings recalled over packaging failures compromising sterility

    MediHoney Adhesive Hydrogel Sheet Dressings, catalog numbers 31720 and 31740, are recalled after packaging failures were identified that could breach the sterile barrier. 994 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2025·2025-09-10

    Interventional imaging systems recalled because single phase UPS may fail on power loss

    Philips Allura systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,006 units are affected.

    Product
    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2505-2025·2025-09-10

    MediHoney paste tubes 31505 recalled over packaging failures affecting sterility

    MediHoney Paste, catalog number 31505, is recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 15,441 units are affected.

    Product
    Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2025·2025-09-10

    Radiotherapy systems recalled over software allowing more than two daily fractions

    RefleXion X1 systems are recalled because an incorrect software configuration potentially allows more than two treatment fractions within a 12-hour period, which could lead to toxicity. 11 units are affected.

    Product
    RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0614-2025·2025-09-10

    KIMMTRAK injection recalled after testing subpotent in three affected lots

    KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, is recalled nationwide as a subpotent drug. 7,572 vials are affected.

    Product
    KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2025·2025-09-10

    MediHoney HCS sheet dressings recalled over packaging failures breaching sterility

    MediHoney HCS Sheet Dressings, catalog numbers 31612, 31622 and 31644, are recalled after packaging failures were identified that could breach the sterile barrier. 3,583 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2025·2025-09-10

    MediHoney non-adhesive hydrogel dressings recalled over sterile barrier packaging failures

    MediHoney Non-Adhesive Hydrogel Sheet Dressings, catalog numbers 31620 and 31640, are recalled after packaging failures were identified that could breach the sterile barrier. 5,374 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2511-2025·2025-09-10

    MediHoney surgical adhesive sheets recalled over sterile barrier packaging failures

    MediHoney HCS Surgical Adhesive Sheet dressings, catalog number 31738, lot 53824, are recalled after packaging failures were identified that could breach the sterile barrier. 4 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0551-2025·2025-09-10

    Breaded butterfly shrimp recalled over possible contamination with cesium-137

    Panko Style Breaded Butterfly Shrimp in 12 lb master cartons, product of Indonesia, is recalled because the product may be contaminated with Cesium-137. 776 cases are affected.

    Product
    Panko Style Breaded Butterfly Shrimp (16/20 CT per pound) in bulk packaging, corrugated master cartons. Master carton case is NET WT 12 lbs. (192 OZ) 5.44 kg (4 x 3lbs cartons), Farm Raised Clean Tail. Product of Indonesia, KEEP FROZEN, Item# 1SH0318505G
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·H-0562-2025·2025-09-10

    Chocolate pecan fudge recalled because pecan and egg are undeclared

    Chocolate Pecan Fudge from The Candy Barn is recalled because the specific tree nut pecan and egg are not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    Chocolate Pecan Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0552-2025·2025-09-10

    Cleantail breaded butterfly shrimp recalled over possible cesium-137 contamination

    Admiral of the Fleet and Portico Seafood Classic cleantail breaded butterfly shrimp in bulk master cartons is recalled because it may be contaminated with Cesium-137. 1,200 cases are affected.

    Product
    ADMIRAL OF THE FLEET and PORTICO SEAFOOD CLASSIC (SYSCO) Cleantail Breaded Butterfly Shrimp (16/20 CT per pound) in bulk packaging, corrugated master cartons. Master carton case is NET WT 12 lbs. (192 OZ) 5.44 kg (4 x 3lbs cartons), and carton case (4 x 3lb (1.36 kg), KEEP…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2496-2025·2025-09-10

    InPen app recalled over software errors affecting insulin dose reminders

    Medtronic is recalling the InPen App for iOS and Android because software design errors could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. 6,816 units are affected.

    Product
    InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0565-2025·2025-09-10

    English toffee recalled because pecans are missing from the contains statement

    English Toffee from The Candy Barn is recalled because the specific tree nut pecans is not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    English Toffee, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 5oz, packed in flexible plastic bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0606-2025·2025-09-10

    Compounded semaglutide 2 mL vials recalled after testing subpotent

    Semaglutide 2.5 mg/mL injection, 2 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 642 vials are affected.

    Product
    Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0619-2025·2025-09-10

    Chlorpromazine 200 mg tablets recalled over micro-organism on packaging component

    Amneal chlorpromazine hydrochloride tablets, 200 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2514-2025·2025-09-10

    Dental titanium bases recalled because the post is oriented 180 degrees off

    NobelBiocare Tri-Lobe-compatible WP 6.0mm engaging titanium bases, lot 277097, are recalled because the base was manufactured 180 degrees around the post from the correct position. 11 units are affected.

    Product
    NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0616-2025·2025-09-10

    Chlorpromazine 25 mg tablets recalled after micro-organism found on packaging coil

    Amneal chlorpromazine hydrochloride tablets, 25 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2501-2025·2025-09-10

    Uric acid monitoring kits recalled over missing premarket clearance or approval

    A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.

    Product
    Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2025·2025-09-10

    Defibrillator recalled because required post-service inspections were not performed

    One LIFEPAK CR2 defibrillator is recalled because required inspections were not performed on units that had gone through servicing.

    Product
    LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not…
    Category
    Medical Device
    Distribution
    Distributed nationwide