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.

28326–28350 of 50488

  • HighUSDA FSIS·pha-07202018-1·2018-07-20

    FSIS Public Health Alert for Hungry Man Dinners with Recalled Whey Powder

    The USDA FSIS issued a public health alert for Hungry Man frozen dinners containing whey powder recalled due to possible Salmonella contamination. No adverse reactions have been reported.

    Product
    FSIS Issues Public Health Alert For Products Containing FDA-Regulated Whey Powder That Has Been Recalled Due To Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18V482000·2018-07-19

    Thor Outlaw Motorhomes Recalled for Missing Rear Reflectors

    Thor Motor Coach is recalling 2018-2019 Outlaw motorhomes because they lack required rear reflex reflectors, which reduces visibility to other drivers.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V474000·2018-07-18

    Micro Bird Recalls School Buses for Seat Foam Crash Protection Defect

    Micro Bird is recalling 2011-2018 school buses because seat foam may not absorb enough impact in a crash, increasing injury risk.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES SCHOOL BUS, MB II SCHOOL BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2018·2018-07-18

    Roche Vitamin D Test System Recalled for Falsely Elevated Results

    Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated, non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.

    Product
    Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2415-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset

    Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a potential device reset caused by a timing interaction between specific diagnostic and pacing features.

    Product
    Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0916-2018·2018-07-18

    Akorn Recalls Acetylcysteine for Injection Due to Manufacturing Deviations

    Akorn, Inc. is recalling 89,507 vials of Acetylcysteine for Injection due to Current Good Manufacturing Practice (CGMP) deviations. The recall is classified as FDA Class II.

    Product
    Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2018·2018-07-18

    GE Medical Systems Recalls Discovery IGS 730 X-ray Systems

    GE Medical Systems is recalling 102 Discovery IGS 730 Interventional Fluoroscopic X-ray Systems due to potential X-ray abort errors that may cause loss of imaging mode.

    Product
    Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2381-2018·2018-07-18

    Intuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component

    Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue during surgery.

    Product
    da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2421-2018·2018-07-18

    Medtronic EnTrust Escudo ICD Recall for Potential Loss of Therapy

    Medtronic is recalling 1,867 EnTrust Escudo ICDs because they may lose high-voltage therapy without a prior alert.

    Product
    Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2018·2018-07-18

    Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Strips

    Immuno-Mycologics is recalling 875 units of Cryptococcal Antigen Lateral Flow Assay strips due to a defect that may cause false negative test results.

    Product
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2378-2018·2018-07-18

    Medline Recalls Bard MYPICC Kits Due to Potential Sterilization Failure

    Medline Industries is recalling specific Bard MYPICC Kits because one case may not have been sterilized. The product was distributed to UT.

    Product
    BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1618-2018·2018-07-18

    Green Tea Latte Recalled for Undeclared Allergens

    Hee Chang Dairy & Food Co., LTD is recalling Green Tea Latte packets because an FDA inspection found undeclared allergens in the product.

    Product
    Green Tea Latte; 35.3 oz. (1 kg) packet Ingredients: White sugar, Instant Whole Milk Powder (Corn Syrup, Milk cream, Lactose, Lecithin, Sodium Caseinate, Non Dairy Creamer (corn Syrup, vegetable oil, sodium caseinate, Silicon Dioxide, Skim Milk Powder, Whey Powder, Green Tea…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2413-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset

    Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a timing interaction that may cause a device reset.

    Product
    Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2018·2018-07-18

    Roche Vitamin D Test System Recalled for Falsely Elevated Results

    Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated and non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.

    Product
    Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk

    Medtronic is recalling 1,842 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.

    Product
    Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2402-2018·2018-07-18

    Stryker Recalls Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.

    Product
    Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2396-2018·2018-07-18

    Stryker Recalls Nine Femoral Nails Due to Potential Premature Breakage

    Stryker GmbH is recalling nine femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.

    Product
    Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2429-2018·2018-07-18

    bioMerieux Recalls VIDAS Analyzers and Quality Control Tests for Performance Issues

    bioMerieux is recalling VIDAS analyzers and Quality Control VIDAS tests due to pump clogging and label displacement that may cause erroneous assay results.

    Product
    BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1620-2018·2018-07-18

    Earthrise Natural Spirulina Recalled for Potential Metal Contamination

    Earthrise Nutritionals is recalling 1,014 boxes of Natural Spirulina because the product may contain small metal pieces from a sifter screen.

    Product
    Earthrise Natural Spirulina; Net Weight: 20.0 kg( 44.0 lbs); Double bag sealed - 1 bag per box. UPC: 0 32602 99040 3
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2424-2018·2018-07-18

    Proteus 235 Proton Beam Device Recalled for Correction Vector Loss

    Ion Beam Applications S.A. is recalling three Proteus 235 units because a software defect may cause patients to be treated in the wrong position.

    Product
    Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2018·2018-07-18

    Steris Reliance 1227 Washer/Disinfector Recalled for Chemical Alarm Failure

    Steris is recalling Reliance 1227 Washer/Disinfector units because the low chemical level alarm does not operate as intended, potentially preventing proper cleaning of patient care items.

    Product
    Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2018·2018-07-18

    Stryker Recalls Reprocessed Coronary Sinus Diagnostic Catheters

    Stryker Sustainability Solutions is recalling 2,722 reprocessed Coronary Sinus Diagnostic EP Catheters because thrombogenicity tests showed they did not meet non-thrombogenic specifications.

    Product
    Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording…
    Category
    Medical Device
    Distribution
    Distributed nationwide