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.

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.

1201–1225 of 1428

  • HighFDA (Devices)·Z-2201-2025·2025-08-06

    Philips Achieva XR gradient coils may act as a heat source

    Achieva XR MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 40 units are affected.

    Product
    Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0544-2025·2025-08-06

    Bicillin L-A penicillin vials recalled after particulates found during visual inspection

    Bicillin L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 50,855 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2191-2025·2025-08-06

    BostonSight PROSE lenses made with sagittal height or haptic errors

    BostonSight PROSE Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 38 units are affected.

    Product
    BostonSight PROSE Lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2219-2025·2025-08-06

    ASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled

    ASPIRE Cristalle Mammography Systems with the Digital Breast Tomosynthesis option are being recalled because devices had an unapproved slabbing software function enabled for use. 293 units affected.

    Product
    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2025·2025-08-06

    Phasor neurosurgical drills may have a reverse battery orientation

    The Phasor Drill, used in neurosurgical procedures, is being recalled because it may have a reverse battery orientation, which may increase surgical time. 1,064 units are affected.

    Product
    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Drugs)·D-0543-2025·2025-08-06

    Timolol eye drop caps can lodge a spike in the nozzle

    Timolol Maleate Ophthalmic Solution USP 0.5% is being recalled because of a defective container: the spike of the cap becomes lodged in the nozzle of the bottle. 154,176 bottles affected.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2196-2025·2025-08-06

    IontoPatch STAT nonwoven pads do not absorb the saline solution

    IontoPatch STAT On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 80,928 units affected.

    Product
    IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2195-2025·2025-08-06

    LYFO-DISK M. canis single packs may fail to recover the organism

    LYFO-DISK M. canis preparations, REF 0894L, are being recalled because they may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2194-2025·2025-08-06

    LYFO-DISK M. canis multipacks may fail to recover the organism

    LYFO-DISK M. canis preparations in 6-pack and 2-pack formats are being recalled because they may result in failure to recover the target microorganism. 32 units are affected.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2025·2025-08-06

    Apic Yamada molding equipment shipped without a required regulatory label

    Apic Yamada WCM series molding equipment, model WCM-330GL-i, is being recalled because certain products may be out of compliance with FDA electronic product regulations for not bearing a required label. 6 units affected.

    Product
    Molding Equipment. WCM series. Model WCM-330GL-i
    Category
    Other
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2193-2025·2025-08-06

    Sprinter Cart infusion poles do not meet IEC 60601-1 labeling requirements

    Sprinter Cart and Sprinter Cart XL Infusion Poles are being recalled because the device does not comply with the labeling requirements of international standard IEC 60601-1. 7,754 units affected.

    Product
    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0380-2025·2025-08-06

    Organic Pure Stevia bottles actually contain mislabeled monk fruit powder

    Organic Pure Stevia, 1 oz, is being recalled because the product is monk fruit powder but the bottle was mislabeled as Organic Pure Stevia. 78 bottles are affected.

    Product
    Organic Pure Stevia, net wt. 1oz. UPC 7 39223 00204 0. Product is packaged in a plastic bottle with white cap. Ingredient: Organic Stevia Extract. Sprinkle a pinch for the perfect sweetness. Suggested Use: 1/64 tsp tastes as sweet as 1 tsp of sugar. Distributed by: NuNaturals, I
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2025·2025-08-06

    BostonSight scleral lenses made with sagittal height or haptic errors

    BostonSight SCLERAL Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 441 units are affected.

    Product
    BostonSight SCLERAL Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0547-2025·2025-08-06

    Sucralfate tablets recalled because bankruptcy left the quality program unmonitored

    Sucralfate Tablets USP 1 gram from Nostrum Laboratories are being recalled across all lots within expiry because the firm cannot monitor its quality program after filing for Chapter 11. 60,608 bottles affected.

    Product
    Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0381-2025·2025-08-06

    Pure Monk Fruit Sweetener bottles actually contain mislabeled stevia powder

    Pure Monk Fruit Sweetener, 0.71 oz, is being recalled because the product is stevia powder but the bottle was mislabeled as Pure Monk Fruit Sweetener. 78 bottles are affected.

    Product
    Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187 6. Product is packaged in a plastic bottle with white cap. Ingredient: Monk Fruit (Luo Han Guo) Extract. Monk Fruit is so much sweeter than sugar, a pinch is all you need. Suggested Use: Add to sweeten your food or be
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2231-2025·2025-08-06

    3M Ranger irrigation fluid warming set notice clarifies flow rates

    The 3M Ranger Irrigation Fluid Warming Set is subject to a notice issued to clarify flow rates related to the inlet fluid temperature. 186,880 units are affected.

    Product
    3M Ranger Irrigation Fluid Warming Set, REF 24750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2025·2025-08-06

    Amlodipine and benazepril capsules released with the wrong expiry date

    Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg are being recalled because they were released with the wrong expiry date, printed as February 2027 instead of January 2027. 7,668 bottles affected.

    Product
    AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2025·2025-08-06

    IontoPatch 80 nonwoven pads do not absorb the saline solution

    IontoPatch 80 On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 63,936 units affected.

    Product
    IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2172-2025·2025-08-06

    Sterilizable Drill Stop Kits were shipped containing incorrect components

    The Drill Stop Kit, a version of the Mini Sterilizable Tray used to store, sterilize and verify drill stop length, is being recalled because it contains incorrect components. 45 kits affected.

    Product
    The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0314-2025·2025-07-30

    Turkeyfoot Creek Creamery mocha artisan ice cream has undeclared soy

    Turkeyfoot Creek Creamery Mocha Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy. All expiration dates are affected.

    Product
    Turkeyfoot Creek Creamery Mocha Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2149-2025·2025-07-30

    Bodor i Series laser cutting machines fail federal laser safety standards

    Bodor i Series laser cutting machines are being recalled because they fail to meet certain applicable federal standards at 21 CFR 1040.10(f)(1) and (f)(2). 20 units are affected.

    Product
    Bodor's I series laser cutting machine.
    Category
    Other
    Distribution
    0 states
  • HighFDA (Devices)·Z-2156-2025·2025-07-30

    Medline C-section prep kits contain ChloraPrep applicators with open seals

    Medline C-SECTION PREP convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 48 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2155-2025·2025-07-30

    Medline blood culture kits contain ChloraPrep applicators with open seals

    Medline blood culture convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 15,700 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
    Category
    Medical Device
    Distribution
    0 states