The Recall Desk

Hazard

Class Ii recalls

1,428 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,428
Critical
0
Severe
0
Most recent
2026-07-08

Of the 1,428 class ii recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all class ii recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

751–775 of 1428

  • 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 (Drugs)·D-0640-2025·2025-09-17

    Mineral sunscreen recalled after SPF testing ranged from 4 to 64

    Ultra Violette Velvet Screen SPF 50 mineral sunscreen is recalled nationwide after testing produced inconsistent SPF results ranging from SPF 4 to 64. 49,275 tubes are affected.

    Product
    Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls
    Category
    Drug
    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 (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 Wilmingto
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0643-2025·2025-09-17

    AvKare chlorpromazine unit dose cartons recalled over presence of foreign substance

    Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in 50-tablet unit dose cartons for AvKare, are recalled nationwide for the presence of a foreign substance. 1,512 cartons are affected.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    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-0632-2025·2025-09-17

    Zydus chlorpromazine 25 mg tablets recalled over nitrosamine above intake limit

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 25 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-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 (Drugs)·D-0637-2025·2025-09-17

    Northstar chlorpromazine 100 mg tablets recalled over N-nitroso impurity level

    Chlorpromazine Hydrochloride Tablets, USP, 100 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-2534-2025·2025-09-17

    Encore Advantage kits recalled over particles migrating from the inflation device

    Boston Scientific Encore Advantage Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 68,347 units are affected.

    Product
    Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
    Category
    Medical Device
    Distribution
    0 states
  • 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 (Drugs)·D-0634-2025·2025-09-17

    Chlorpromazine 50 mg tablets recalled over nitrosamine exceeding acceptable intake limit

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 50 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-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
  • HighFDA (Devices)·Z-2553-2025·2025-09-17

    Hemostasis valves recalled because deformed quad rings may shed foreign bodies

    10Fore Hemostasis Valves are recalled because of a manufacturing issue where the silicone quad ring is deformed or damaged and may cause a foreign body in the fluid pathway. 447 units are affected.

    Product
    10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2025·2025-09-17

    ENT convenience packs recalled over open header bag seals compromising sterility

    Halyard ENT Packs, model JACK421-04, lot 1647218, are recalled because of the potential for open header bag seals, compromising sterility. 57 units are affected.

    Product
    Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
    Category
    Medical Device
    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 (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 (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 (Devices)·Z-2549-2025·2025-09-17

    Shoulder glenoid tray kits recalled because the reamer may kick or bind

    DJO Surgical FA S Altivate Reverse Glenoid Tray kits are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 439 kits are affected.

    Product
    Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2025·2025-09-17

    Angled punch awls recalled following failure of fusion system instruments

    TiBrid SA Angled Punch Awls in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.

    Product
    TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
    Category
    Medical Device
    Distribution
    Distributed nationwide