The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

10001–10025 of 29157

  • SevereFDA (Devices)·Z-1144-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recalled for Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1134-2020·2020-02-26

    Abbott Vascular Recalls NC TREK Coronary Dilatation Catheters

    Abbott Vascular is recalling NC TREK RX Coronary Dilatation Catheters because the balloon may have difficulty or inability to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0951-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling three Trilogy EVO Ventilators in Italy because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0850-2020·2020-02-26

    NCS Healthcare Recalls Glycopyrrolate Tablets Due to Impurity Failure

    NCS Healthcare of Kentucky Inc is recalling 6,929 blister cards of Glycopyrrolate Tablets, USP, 1 mg, due to high out-of-specification results for an unknown impurity.

    Product
    Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1278-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise sterility.

    Product
    Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0953-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 27 Trilogy EVO ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0945-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 48 Trilogy EVO ventilators due to a software defect that causes inoperative power alarms. The units were distributed in 15 countries outside the US.

    Product
    Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accesso
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0708-2020·2020-02-26

    Dragonfly Botanicals Breathe Deep Recalled for Internal Use of Coltsfoot

    Green Water, LLC is recalling Dragonfly Botanicals Breathe Deep dietary supplements because they contain Coltsfoot, which is not to be used internally.

    Product
    Dragonfly Botanicals Full spectrum Breathe Deep 1000mg/oz Dietary Supplement, sold in 0.5 oz, 1 oz, 2 oz, and 4 oz amber glass bottles with dropper.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1272-2020·2020-02-26

    Philips HeartStart AEDs Recalled for Quality Standards Defect

    Philips is recalling 96 HeartStart AEDs because their Printed Circuit Assemblies were not manufactured or repaired to quality standards.

    Product
    Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
    Category
    Medical Device
    Distribution
    9 states
  • SevereNHTSA·20V112000·2020-02-26

    Nissan Recalls 2020 Versa Vehicles for Fuel Tank Manufacturing Defect

    Nissan is recalling 2020 Versa vehicles because a manufacturing issue may cause a small hole in the fuel tank seam, potentially leading to a fuel leak and fire risk.

    Product
    NISSAN — NISSAN VERSA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1286-2020·2020-02-26

    Recall of Polysorb Sutures Due to Potential Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact sterility.

    Product
    Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0705-2020·2020-02-26

    ABH Nature's Products Recalls All Dietary Supplements for cGMP Violations

    ABH Nature's Products Inc. is recalling all dietary supplements under a consent decree because they were prepared, packed, or held in violation of current good manufacturing practice regulations.

    Product
    All Dietary Supplement manufactured and distributed by ABH Nature's Products Inc.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1333-2020·2020-02-26

    Siemens Uroskop Omnia max Recalled for Collision Control Override Risk

    Siemens is recalling 192 Uroskop Omnia max devices because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.

    Product
    Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1138-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoc
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1139-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0944-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 31 Trilogy EVO Ventilators due to a software defect that causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1137-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0946-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 105 Trilogy EVO ventilators because a software defect causes inoperative power alarms. The units are distributed internationally but not in the US.

    Product
    Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate acces
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1142-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Balloon Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may fail to deflate. The device is not cleared for commercial distribution in the US.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1140-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1131-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheter Recall for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0707-2020·2020-02-26

    Taspen's Organics Breathe Easy Herbal Tincture Recalled for Coltsfoot

    Green Water, LLC is recalling Taspen's Organics Breathe Easy Herbal Tincture because it contains Coltsfoot, which is not to be used internally.

    Product
    Taspen's Organics Breathe Easy Herbal Tincture Dietary Supplement, sold in 1 oz, 2 oz, and 4 oz amber glass bottles with dropper.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V105000·2020-02-25

    Keystone Recalls 2020 Trailers Due to Spare Tire Carrier U-Bolt Failure

    Keystone RV Company is recalling 2020 Crossroads Zinger, Hideout, and Springdale trailers because spare tire carrier U-bolts may fail, allowing the carrier and tire to detach.

    Product
    KEYSTONE — KEYSTONE HIDEOUT, SPRINGDALE, CROSSROADS ZINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V109000·2020-02-25

    Mercedes-Benz Sprinter Recall for Steering Spindle Bearing Screw Defect

    Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because steering spindle screws may loosen, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 1500, SPRINTER 2500, SPRINTER 4500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide