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.

851–875 of 1428

  • ModerateFDA (Devices)·Z-2518-2025·2025-09-10

    Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement

    Merge Hemo systems are recalled because certain Schiller ARGUS PB-3000 patient data modules trigger a Pressure Sensor Defective error during non-invasive blood pressure measurement above 240 mmHg. 84 units are affected.

    Product
    Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2500-2025·2025-09-10

    Uric acid meter kits recalled for distribution without premarket clearance

    Blood Uric Acid Monitoring System kits, model eB-U01, are recalled because the products were distributed without premarket clearance or approvals. 2,240 units are affected.

    Product
    Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2025·2025-09-10

    RayStation 11A planning software recalled over non-unique DICOM instance identifiers

    RayStation 11A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Softw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2493-2025·2025-09-10

    RayStation 12A planning software recalled over duplicate DICOM instance identifier risk

    RayStation 12A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2501-2025·2025-09-10

    Uric acid monitoring kits recalled over missing premarket clearance or approval

    A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.

    Product
    Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2494-2025·2025-09-10

    RayStation 6 service packs recalled over DICOM identifier uniqueness defect

    RayStation 6 Service Packs 1, 2 and 3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2025·2025-09-10

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

    Amneal chlorpromazine hydrochloride tablets, 50 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0615-2025·2025-09-10

    Sulfamethoxazole and trimethoprim tablets recalled over micro-organism on packaging coil

    Amneal sulfamethoxazole and trimethoprim double strength tablets are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2488-2025·2025-09-10

    RayStation 8B and 9A software recalled over DICOM identifier uniqueness defect

    RayStation 8B, its service packs and 9A radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2025·2025-09-03

    Hysterectomy procedure packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems robotic and vaginal hysterectomy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 50 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2423-2025·2025-09-03

    Limb salvage canal filling stems recalled after unidentified substance found on devices

    ELEOS Bowed Canal Filling Stems are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 30 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2025·2025-09-03

    Custom loupes with Phantom frames recalled over nickel nose pad allergy risk

    Orascoptic custom loupes configured with Phantom frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 10,611 units are affected.

    Product
    Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2025·2025-09-03

    Laparoscopy and pelviscopy packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems laparoscopy and pelviscopy procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,094 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2424-2025·2025-09-03

    Canal filling stems recalled after unidentified substance found during retrospective evaluation

    ELEOS Segmental Stem Canal Filling straight slotted splined 2/3 plasma implants are recalled because an unidentified substance of unknown impact was found on devices. 15 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2025·2025-09-03

    Labor and delivery packs recalled over unconfirmed product sterilization assurance

    American Contract Systems Born on Arrival kits and Labor & Delivery packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 781 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2472-2025·2025-09-03

    Hip and knee procedure packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2341-2025·2025-09-03

    OEC 9800 C-arm systems recalled over missing collimator cover lead tape

    GE HealthCare OEC 9800 C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.

    Product
    GE HealthCare OEC 9800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0604-2025·2025-09-03

    Good Neighbor alcohol prep pads recalled for alcohol below labeled concentration

    Good Neighbor Pharmacy Alcohol Prep Pads, distributed by AmerisourceBergen, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. 66,000 pads are affected.

    Product
    GOOD NEIGHBOR PHARMACY ALCOHOL ANTISEPTIC SKIN CLEANSER — GOOD NEIGHBOR PHARMACY ALCOHOL ANTISEPTIC SKIN CLEANSER (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2025·2025-09-03

    Phantom nose pad kits recalled because nickel content may cause allergic reaction

    Orascoptic Phantom Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 22 kits are affected.

    Product
    Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2442-2025·2025-09-03

    Dragonfly Essentials loupe kits recalled because nickel nose pads may cause allergy

    Orascoptic Dragonfly Essentials Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 32 kits are affected.

    Product
    Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0603-2025·2025-09-03

    H-E-B alcohol pads recalled for isopropyl alcohol below labeled concentration

    H-E-B inControl Sterile Alcohol Pads, 100 per container, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 300,000 pads.

    Product
    INCONTROL ALCOHOL — INCONTROL ALCOHOL (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2025·2025-09-03

    Sucralfate tablets recalled after bankruptcy left quality program unmonitored

    Sucralfate Tablets USP 1 gram from American Health Packaging are recalled because the firm's Chapter 11 filing left it unable to monitor its quality program. 26,992 blister packs are affected.

    Product
    Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0599-2025·2025-09-03

    Lisdexamfetamine 40 mg bottles recalled after being filled with 30 mg capsules

    Lisdexamfetamine Dimesylate Capsules 40 mg, lot 25280726A, distributed by Lannett, are recalled because a bottle labeled 40 mg contained 30 mg capsules. 8,544 bottles are affected.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0600-2025·2025-09-03

    Medline alcohol prep pads recalled for alcohol below labeled concentration

    Medline Alcohol Prep Pads, 70% isopropyl alcohol, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 6,669,874 swabs.

    Product
    MEDLINE ALCOHOL PREP — MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide