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.

Which agencies issued them

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.

701–725 of 1428

  • HighFDA (Drugs)·D-0658-2025·2025-09-24

    Technetium mertiatide kits recalled after out-of-specification sulphate in a raw material

    Sun Pharmaceutical's Kit for the Preparation of Technetium Tc 99m Mertiatide, lot AD70995, is recalled after an out-of-specification result for sulphate in the sodium tartrate dihydrate used in production. 1,870 kits are affected.

    Product
    KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE — KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE (BETIATIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0583-2025·2025-09-24

    Cocktail shrimp recalled over possible contamination with cesium-137

    AquaStar Cocktail Shrimp with cocktail sauce, 6 oz packages sold at Walmart, is recalled because the product may be contaminated with Cesium-137. 22,500 cases are affected.

    Product
    AquaStar Cocktail Shrimp, 4oz. shrimp/2oz. cocktail sauce. Each case consists of 6x6 oz packages, UPC 19434612191. Distributed by Aqua Star, Seattle, WA. Farm Raised Product of Indonesia. Master cases distributed to distributors in frozen condition. AquaStar Cocktail Shrimp, 4oz
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·H-0580-2025·2025-09-24

    Sea salt caramel miniatures recalled because peanut and pecan are undeclared

    Abdallah Candies Sea Salt Caramel Dark Miniature, item 2237 ML in a 5.20 lb box, is recalled for undeclared peanut and pecan. One box distributed in Pennsylvania is affected.

    Product
    Sea Salt Caramel Dark Miniature, Item ID: 2237 ML. Packed On (YYMMDD): 25-07-22. 5.20 lb. Box. Abdallah Candies
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2575-2025·2025-09-24

    DxH 600 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0645-2025·2025-09-24

    Aripiprazole 10 mg tablets recalled after testing superpotent in one lot

    Aripiprazole Tablets, USP, 10 mg, lot 24144162, distributed by Ascend Laboratories, are recalled nationwide as a superpotent drug. 2,256 bottles are affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2025·2025-09-24

    Heartstring III 3.8 mm seal systems recalled over three identified failure modes

    Heartstring III Proximal Seal Systems, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.

    Product
    Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0602-2025·2025-09-24

    Pecan bars recalled after label review found milk and soy missing

    Bake-a-holic Cheesecake Royale Pecan Bars are recalled because a label review found milk and dairy absent from the Contains statement and soy removed from the label. 60 cases are affected.

    Product
    Bake-a-holic Pecan Bars Cheesecake Royale Pecan Bars
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2564-2025·2025-09-24

    CD20 reagent lots recalled over weak staining risking false negative identification

    FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2CN, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 65 units are affected.

    Product
    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0653-2025·2025-09-24

    Sodium chloride irrigation bags recalled over port misalignment allowing fluid leakage

    B. Braun 0.9% Sodium Chloride Irrigation USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 16,228 bags are affected.

    Product
    SODIUM CHLORIDE FOR IRRIGATION — SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0619-2025·2025-09-24

    Inositol powder recalled over possible Staphylococcus aureus contamination in finished product

    BulkSupplements.com Inositol powder, lot 2507803, is recalled because the finished product may be contaminated with pathogenic Staphylococcus aureus. 1,001 units are affected.

    Product
    Brand name: BulkSupplements.com Generic name: Inositol. Dosage: 1 gram. Form: Powder. Route of administration: Oral. Packaging is flexible plastic. Net Wt.: 8.8 oz (250 grams), 1.1 lbs (500 grams), 2.2 lbs (1 kilogram). UPC: 849720004147, 849720004154, 849720004161 Firm Name/
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0581-2025·2025-09-24

    Cream caramels recalled because peanut and pecan are undeclared allergens

    Abdallah Candies Cream Caramels, Milk, item 2210L in a 6.26 lb box, are recalled for undeclared peanut and pecan. One box distributed in Pennsylvania is affected.

    Product
    Cream Caramels, Milk, Item ID: 2210L. Packed On (YYMMDD): 25-06-16. 6.26 lb. Box. Abdallah Candies
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2563-2025·2025-09-24

    CD20 antibody reagent recalled over weak staining causing false negative results

    FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis is recalled because of the potential for weak staining, which may result in false negative CD20 identification. 4,145 units are affected.

    Product
    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0604-2025·2025-09-24

    Frozen cooked shrimp recalled over insanitary conditions and possible cesium-137

    Best Yet, Arctic Shores and Great American branded frozen cooked shrimp is recalled because it was made under insanitary conditions and may have been contaminated with Cesium-137. 11,081 cases are affected.

    Product
    Best Yet; Arctic Shores; and Great American branded Frozen cooked shrimp; 1 Pound/ 12 OZ/ 6 OZ/ 2 Pound plastic bag; (Various Brands) UPC#: 042187002736; 042187002743; 041130812392; 041130810497; 041130810411; 041130811685; 829944092540; 829944012173
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2570-2025·2025-09-24

    Radiation planning software recalled over image errors in three patient orientations

    Pinnacle Radiation Therapy Planning System software is recalled because of a potential image error of the Region of Interest for expansion or contraction in head first prone, feet first supine and feet first prone orientations.

    Product
    Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2025·2025-09-24

    Reverse shoulder liners recalled over articular surface outside dimensional specification

    Exactech Equinoxe Reverse Shoulder humeral liners under REF 320-38 and 320-42 are recalled because the articular surface position falls outside the dimensional specification in the labeling. 61,334 units are affected.

    Product
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0648-2025·2025-09-24

    Chlorpromazine 50 mg blisterpacks recalled over micro-organism on packaging coil

    Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in blisterpacks from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,062 cartons are affected.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0649-2025·2025-09-24

    Chlorpromazine 100 mg cartons recalled over micro-organism on packaging coil

    Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in blisterpack cartons from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,757 cartons are affected.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2582-2025·2025-09-24

    Blood gas cartridges recalled for lacking clearance covering updated measurement ranges

    i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.

    Product
    i-STAT CG4+ cartridge (white). List Number: 03P85-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2578-2025·2025-09-24

    Distraction pins in five packs recalled over unvalidated shelf life

    Frontier Devices 14 mm Distraction Pins in 5 single packs are recalled because the labeling includes a shelf life that has not been validated. 2,700 units are affected.

    Product
    Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2579-2025·2025-09-24

    Fourteen millimetre distraction pins recalled over unvalidated shelf life labeling

    Frontier Devices 14 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 10,960 units are affected.

    Product
    Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2577-2025·2025-09-24

    Twelve millimetre distraction pins recalled over unvalidated shelf life labeling

    Frontier Devices 12 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated. 160 units are affected.

    Product
    Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2559-2025·2025-09-24

    Lactate test slides recalled over calibration failures delaying patient results

    VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 units are affected.

    Product
    Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0654-2025·2025-09-24

    Double strength antibiotic bottles recalled over micro-organism on packaging coil

    Sulfamethoxazole and Trimethoprim Tablets, USP 800 mg/160 mg double strength, in 6, 10, 14 and 20-count bottles are recalled because a micro-organism was found on a lot of packaging coil.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide