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.

6276–6300 of 88183

  • HighFDA (Devices)·Z-2536-2025·2025-09-17

    UroMax Ultra kits recalled over particles migrating from the inflation device

    Boston Scientific UroMax Ultra Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 1,369 units are affected.

    Product
    Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2548-2025·2025-09-17

    Glenoid reamer sleeves recalled over potential for reamer kicking or binding

    DJO Surgical Altivate Reverse Wedge Glenoid Reamer Sleeves are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 447 units are affected.

    Product
    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0630-2025·2025-09-17

    Zydus chlorpromazine 10 mg tablets recalled over N-nitroso desmethyl chlorpromazine

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 10 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2533-2025·2025-09-17

    Encore 26 inflation devices recalled over foreign material particles migrating into catheters

    Boston Scientific Encore 26 Inflation Devices are recalled because foreign material particles could migrate from the device into a balloon dilatation catheter during use. 39,739 units are affected.

    Product
    Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0638-2025·2025-09-17

    Chlorpromazine 200 mg from Zydus recalled over N-nitroso desmethyl impurity

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 200 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0633-2025·2025-09-17

    Northstar chlorpromazine 25 mg tablets recalled over nitrosamine above intake limit

    Chlorpromazine Hydrochloride Tablets, USP, 25 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2025·2025-09-17

    Urinary protein assay recalled over falsely depressed patient and calibration results

    Atellica CH Urinary/Cerebrospinal Fluid Protein assay is recalled because of the potential for falsely depressed patient, quality control and calibration results, or delayed results. 11,811 units are affected.

    Product
    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0639-2025·2025-09-17

    Chlorpromazine 200 mg tablets recalled over nitrosamine impurity above acceptable intake

    Chlorpromazine Hydrochloride Tablets, USP, 200 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0636-2025·2025-09-17

    Zydus chlorpromazine 100 mg tablets recalled over nitrosamine impurity above limit

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 100 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2025·2025-09-17

    Introducer sheath systems recalled over pouch labels showing the wrong size

    Fortress Introducer Sheath Systems, 6F straight 45 cm, lot 800989, are recalled because units may carry a pouch label listing the reference number and UDI of the 4F version. 2,500 units are affected.

    Product
    Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0644-2025·2025-09-17

    AvKare chlorpromazine 100 mg cartons recalled over presence of foreign substance

    Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in 50-tablet unit dose cartons for AvKare, are recalled nationwide for the presence of a foreign substance. 2,003 cartons are affected.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2025·2025-09-17

    NephroMax kits recalled because inflation device particles may enter balloon catheters

    Boston Scientific NephroMax Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 458 units are affected.

    Product
    Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2543-2025·2025-09-17

    Cardiovascular software recalled because it may display outdated information

    IntelliSpace Cardiovascular software version 8.0.0.4 is recalled because of a software issue that results in the display of outdated information. 4 units are affected.

    Product
    IntelliSpace Cardiovascular, Software 8.0.0.4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0641-2025·2025-09-17

    Mini sunscreen kits recalled after SPF testing produced inconsistent results

    Ultra Violette Mini SPF Mates kits are recalled nationwide after testing of the SPF 50 sunscreen produced inconsistent results ranging from SPF 4 to 64. 44,497 tubes are affected.

    Product
    Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2554-2025·2025-09-17

    Spinal inserters recalled over difficulty disengaging implants and incorrect UDI marking

    Reef TA Inserters, part number TA2-001003, are recalled because they may contribute to difficulty disengaging the implant or improper implant positioning, and may carry incorrect UDI-DI marking. 74 units are affected.

    Product
    Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0631-2025·2025-09-17

    Chlorpromazine 10 mg tablets recalled over N-nitroso impurity above limit

    Chlorpromazine Hydrochloride Tablets, USP, 10 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2025·2025-09-17

    CELSITE BabyPort sets recalled over potential vessel damage or tearing

    CELSITE BabyPort Set PUR 4.5F IV, catalog 5433742, lot 37041185, is recalled because of the potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. 58 units are affected.

    Product
    Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2025·2025-09-17

    Knee tibial components recalled because security screws were left uncoated

    LinkSymphoKnee modular TiNbN tibial components, size 5, REF 880-100/50, are recalled because some were manufactured with two uncoated security screws. 8 units are affected.

    Product
    LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0635-2025·2025-09-17

    Northstar chlorpromazine 50 mg tablets recalled over nitrosamine impurity level

    Chlorpromazine Hydrochloride Tablets, USP, 50 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2546-2025·2025-09-17

    Glenoid reamer heads recalled because they may kick or bind during use

    DJO Surgical Altivate Reverse Wedge Glenoid Reamer Heads are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 927 units are affected.

    Product
    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0624-2025·2025-09-17

    Major Pharmaceuticals antibiotic cartons recalled over micro-organism on packaging coil

    Sulfamethoxazole and Trimethoprim double strength unit dose cartons from Major Pharmaceuticals are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0573-2025·2025-09-17

    WINN-50 dietary supplement recalled after testing subpotent for vitamin B12

    Anabolic Research WINN-50, 90 capsules, lot 2307149, is recalled nationwide because degradation of an ingredient left the product subpotent for vitamin B12. 1,566 bottles are affected.

    Product
    Anabolic Research WINN-50 (vanazolol). Dietary Supplement. 90 Capsules. UPC 8 51840-00707 6. Manafactured For: Anabolic Research, 6942 FM 1960 E. #346, Humble, TX 77346-2706.
    Category
    Food
    Distribution
    Distributed nationwide