The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

13076–13100 of 22165

  • HighFDA (Drugs)·D-0171-2024·2024-01-03

    Bumetanide Tablets Recalled for Exposure to Improper Storage Temperatures

    Bumetanide tablets manufactured by Amneal Pharmaceuticals are being recalled because they were exposed to temperatures outside their labeled storage conditions. The recall affects batch AM211171 distributed nationwide.

    Product
    Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0615-2024·2024-01-03

    Medtronic SynchroMed II Programmable Pump May Fail to Resume Drug Delivery After MRI

    The Medtronic SynchroMed II pump may fail to resume medication delivery after an MRI scan if the device switches to telemetry mode due to electromagnetic interference while alarming. The pump will not resume normal operation after leaving the MRI magnetic field.

    Product
    Medtronic SynchroMed II, Model 8637-40, Programmable pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0181-2024·2024-01-03

    Lansoprazole Suspension Recalled Due to Temperature Storage Deviations

    A prescription lansoprazole suspension has been recalled because batches were exposed to temperatures outside the manufacturer's labeled storage range. This manufacturing quality issue affects Batch 21025A nationwide.

    Product
    FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0166-2024·2024-01-03

    Amoxicillin tablets recalled due to improper storage temperature exposure

    Cardinal Healthcare is recalling Amoxicillin 875mg tablets due to CGMP deviations where products were exposed to temperatures outside their labeled storage conditions, affecting nationwide distribution.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2024·2024-01-03

    DeRoyal Cardiac Cath Kit Recalled for Defective Pressure Transducers

    DeRoyal Industries is recalling a cardiac catheterization kit that contains Edwards Life Sciences pressure transducers that were subject to a separate recall by their manufacturer.

    Product
    DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0196-2024·2024-01-03

    Rivastigmine Transdermal Patch Recalled Due to Temperature Exposure

    Cardinal Healthcare is recalling Rivastigmine Transdermal System patches (4.6 mg/24 hours) distributed nationwide because they were exposed to temperatures outside labeled storage conditions during manufacturing.

    Product
    RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0163-2024·2024-01-03

    Albuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation

    Cardinal Healthcare is recalling Albuterol Sulfate inhalers (Batch K100715) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Approximately 11 cartons were distributed nationwide. Contact your pharmacist or doctor for a replacement.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0201-2024·2024-01-03

    Warfarin Sodium Tablets Recalled Due to Temperature Storage Deviation

    Cardinal Healthcare recalls Warfarin Sodium Tablets (5 mg) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.

    Product
    WARFARIN SODIUM — WARFARIN SODIUM (WARFARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2024·2024-01-03

    Arjo Medical Beds Recalled Due to Unintended Wheel Movement

    Arjo medical beds with IndiGo Drive Assistance modules may have wheels that move unintentionally. This recall affects 83 units in seven U.S. states.

    Product
    Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0188-2024·2024-01-03

    FDA Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Temperature Storage Deviations

    Cardinal Healthcare is recalling Lisinopril and Hydrochlorothiazide Tablets (10mg/12.5mg) manufactured by Lupin Limited because products were exposed to temperatures outside the labeled storage conditions. Affected batches are Q101699 and Q101981 distributed nationwide.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2024·2024-01-03

    Respiratory inhalation medication recalled for temperature storage deviation

    Cardinal Healthcare is recalling an ipratropium bromide and albuterol sulfate inhalation solution nationwide after the product was exposed to temperatures outside labeled storage conditions. The deviation may affect drug potency.

    Product
    IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0202-2024·2024-01-03

    Prescription Inhalation Powder Recalled for Storage Temperature Deviation

    Cardinal Healthcare recalls batch 62002532 of Wixela Inhub inhalation powder nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, potentially affecting product stability.

    Product
    WIXELA INHUB — WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2024·2024-01-03

    Acumed RibLoc U Plus 90 Surgical Guide Recalled for Potential Breakage

    Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.

    Product
    RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0204-2024·2024-01-03

    FDA Recalls AnazaoHealth Injectable Vitamin Solution Due to Particulate Matter

    AnazaoHealth Corporation is recalling 3,363 vials of Thiamine HCl/Pyridoxine HCl injection solution nationwide due to the presence of particulate matter. Affected lots are identified by lot numbers and expiration dates listed by the FDA.

    Product
    Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0180-2024·2024-01-03

    Estradiol 0.5mg Tablets Recalled Nationwide for Storage Temperature Deviation

    Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2024·2024-01-03

    Atrium Oasis surgical drain recalled for premature sterilization expiration

    Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.

    Product
    Atrium Oasis Drain Single W / AC, Part No. 3600-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V169000·2024-01-03

    2018-2023 Kia Stinger Turbocharger Oil Leak Engine Fire Risk

    Kia is recalling 2018-2023 Stinger and 2019-2020 K900 vehicles due to potential engine fire from deteriorating turbocharger oil feed pipes.

    Product
    KIA — 2020 KIA STINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V191000·2024-01-03

    2021 Ford Escape Engine Oil Separator May Crack and Leak

    Ford is recalling 2020-2022 Escape and 2021-2022 Bronco Sport with 1.5L engines. The oil separator housing may crack and leak, creating fire risk near hot engine components.

    Product
    FORD — 2021 FORD ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0192-2024·2024-01-03

    Topical antifungal Nyamyc recalled due to storage temperature deviations

    Cardinal Healthcare is recalling Nyamyc topical antifungal medication (Batch 400454) nationwide due to exposure to temperatures outside labeled storage conditions.

    Product
    Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2024·2024-01-03

    Alinity ci-series System Control Module Software Performance Issues Recalled

    Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.

    Product
    Alinity ci-series System Control Module, REF: 03R70-01
    Category
    Medical Device
    Distribution
    46 states
  • HighNHTSA·22V184000·2024-01-03

    2022 Forest River Puma Recreational Vehicles Griddle Fire Hazard Recall

    Forest River is recalling 2022 Puma and Puma XLE fifth wheel and travel trailer recreational vehicles because the exterior microwave griddle can remain connected to propane when stowed, creating a fire hazard.

    Product
    FOREST RIVER — 2022 FOREST RIVER PUMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0179-2024·2024-01-03

    Enoxaparin Sodium Injection recalled due to improper storage conditions

    Sandoz Inc is recalling Enoxaparin Sodium Injection (batch SAH06821A) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.

    Product
    ENOXAPARIN SODIUM — ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V187000·2024-01-03

    2022 Lincoln Aviator PHEV Charge Port Harness Bus Bar Unseating Risk

    Ford is recalling 2022 Lincoln Aviator PHEV vehicles. The inlet charge port harness bus bar may unseat, causing loss of drive power and increasing crash risk.

    Product
    LINCOLN — 2022 LINCOLN AVIATOR PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0203-2024·2024-01-03

    B-Complex Vitamin Injection Vials Recalled for Particulate Matter

    AnazaoHealth is recalling B-Complex injection vials due to particulate matter contamination. Affected patients should discontinue use and consult their healthcare provider.

    Product
    B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3
    Category
    Drug
    Distribution
    Distributed nationwide