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.

1026–1050 of 1428

  • ModerateFDA (Drugs)·D-0584-2025·2025-08-20

    Belsomra 10 mg tablets failed dissolution, which may delay sleep onset

    Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.

    Product
    BELSOMRA — BELSOMRA (SUVOREXANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2025·2025-08-20

    SIGNA PET/MR imager recalled over unconfirmed patient table caster lock checks

    GE HealthCare is recalling 97 SIGNA PET/MR imagers because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2305-2025·2025-08-20

    SIGNA UHP patient table caster lock checks may have been missed

    GE SIGNA UHP MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 3 units affected.

    Product
    GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2289-2025·2025-08-20

    Plastic trial heads carry inconsistent size terminology and color coding

    Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.

    Product
    Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2025·2025-08-20

    SIGNA Voyager AIR MRI recalled over unverified patient table caster lock maintenance

    GE HealthCare is recalling SIGNA Voyager AIR (China Only) MRI systems because a planned maintenance step checking the patient table caster locks may not have been performed.

    Product
    GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2310-2025·2025-08-20

    SIGNA Artist Evo MRI recalled over unverified patient table caster lock checks

    GE HealthCare is recalling 138 SIGNA Artist Evo MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0583-2025·2025-08-20

    Theophylline extended-release tablets failed dissolution at long-term stability testing

    Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2314-2025·2025-08-20

    SIGNA Premier Elite MRI recalled because caster lock maintenance check may be missing

    GE HealthCare is recalling SIGNA Premier Elite (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2298-2025·2025-08-20

    Ultra IABP catheter kits carry indications not reviewed by the FDA

    Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.

    Product
    Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2300-2025·2025-08-20

    Signa Voyager MRI recalled where patient table caster lock checks unconfirmed

    GE HealthCare is recalling 280 Signa Voyager MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2316-2025·2025-08-20

    SIGNA Hero XT patient table caster lock checks may have been missed

    GE SIGNA Hero XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Product
    GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2301-2025·2025-08-20

    Discovery MR450 1.5T scanners recalled over patient table caster lock maintenance

    GE HealthCare is recalling 19 Discovery MR450 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2320-2025·2025-08-20

    SIGNA PET/MR AIR Plus recalled over unperformed patient table caster lock maintenance

    GE HealthCare is recalling SIGNA PET/MR AIR Plus (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2318-2025·2025-08-20

    SIGNA Hero MAX patient table caster lock checks may have been missed

    GE SIGNA Hero MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Product
    GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0559-2025·2025-08-13

    Compounded tirzepatide 13.2 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 13.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 143 vials are affected.

    Product
    Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·H-0385-2025·2025-08-13

    Favorite Day frosted sugar cookies may contain wood foreign material

    Favorite Day Bakery Frosted Sugar Cookies, 10 count, are being recalled because of foreign material, specifically wood. 803 cases are affected.

    Product
    Favorite Day Bakery Frosted Sugar Cookies, 10 count, Net Wt 13.5 oz (383g). UPC - 85239-41250 3. Dist. By Target Corporation, Minneapolis, MN 55403. Product of Canada.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Drugs)·D-0562-2025·2025-08-13

    Compounded semaglutide and cyanocobalamin vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 0.88 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 194 vials are affected.

    Product
    Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0568-2025·2025-08-13

    Direct Rx duloxetine 30 mg capsules exceed the interim nitrosamine limit

    Duloxetine Delayed-Release 30 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 875 bottles affected.

    Product
    Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0384-2025·2025-08-13

    Queen Bee Gardens whipped honey may contain stainless steel flakes

    Queen Bee Gardens Whipped Honey Huckleberry in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 24 jars are affected.

    Product
    Brand Name: Queen Bee Gardens Whipped Honey Huckleberry Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182259. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0567-2025·2025-08-13

    Duloxetine delayed-release capsules exceed the interim nitrosamine impurity limit

    Duloxetine Delayed-Release 20 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 16 bottles affected.

    Product
    Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0564-2025·2025-08-13

    Compounded semaglutide 2.21 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 2.21 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 176 vials are affected.

    Product
    Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0552-2025·2025-08-13

    Duloxetine 60 mg capsules exceed the safety assessment limit for nitrosamine

    Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2275-2025·2025-08-13

    Size 2 Guedel airways may carry small burrs that could detach

    One-piece Guedel airways, size 2, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 2,800 pieces are affected.

    Product
    One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·H-0382-2025·2025-08-13

    Queen Bee Gardens raspberry whipped honey may contain stainless steel flakes

    Queen Bee Gardens Whipped Honey Raspberry in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 129 jars are affected.

    Product
    Brand Name: Queen Bee Gardens Whipped Honey Raspberry. Intended use: spread. Item is shelf stable. Packaging type: Jar. Net wt., 11oz. UPC: 788394182358. Firm Name: Queen Bee Gardens Firm Address: 262 East Main Street, Lovell, WY 82431
    Category
    Food
    Distribution
    Distributed nationwide