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.

23776–23800 of 50435

  • HighFDA (Devices)·Z-1124-2020·2020-02-19

    Flowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2020·2020-02-19

    Terumo AZUR Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 19 units of Terumo AZUR Peripheral Coil Systems because the implant coil may be missing from the device.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1148-2020·2020-02-19

    Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues

    Stryker is recalling 87 Omega 4.75 mm PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.

    Product
    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-0740-2020·2020-02-19

    Ready Pac Bistro Spinach Dijon Salad Recalled for Undeclared Allergens

    Ready Pac Foods is recalling Spinach Dijon Salad because the label fails to declare eggs and wheat.

    Product
    Ready Pac Bistro - Spinach Dijon Salad with Sweet Onion Dijon Vinaigrette; Baby Spinach, Hard Boiled Eggs, Monterey Jack-Colby Cheese, Crispy Noodles, Almonds, Dried Cranberries with Sweet Onion Dijon Vinaigrette. Net Wt. 4.75 oz. (135 g). UPC: 0 77745 29795 8…
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1150-2020·2020-02-19

    Medtech ROSA Brain 3.0 Software Recalled for Image Reconstruction Errors

    Medtech SAS is recalling ROSA Brain 3.0 software because cross-sectional images may not display properly, potentially compromising surgery planning.

    Product
    ROSA Brain 3.0 Application-Brain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1147-2020·2020-02-19

    Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues

    Stryker is recalling 73 Omega PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.

    Product
    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1154-2020·2020-02-19

    Respironics Ventilator Touchscreen Recall Due to Unresponsive Controls

    Respironics is recalling V60/V680 ventilator touchscreens that may freeze and fail to respond to touch commands, potentially delaying necessary therapy adjustments.

    Product
    Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2020·2020-02-19

    bioMerieux Recalls VIDAS Varicella Zoster IgG Antibody Test Kits

    bioMerieux is recalling VIDAS Varicella Zoster IgG antibody kits due to potential invalid calibrations or false positive results.

    Product
    VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2020·2020-02-19

    Respironics V680 Ventilator Recalled for Unresponsive Touchscreen

    Respironics is recalling 190 V680 Ventilators because the touchscreen may freeze, preventing clinicians from adjusting therapy settings and potentially causing delayed treatment.

    Product
    Respironics V680 Ventilator, Service # 850011, (OUS Only)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20074·2020-02-19

    Contigo Recalls 5.7 Million Kids Water Bottles Due to Choking Hazard

    Contigo is reannouncing a recall of 5.7 million kids water bottles because the clear silicone spout can detach, posing a choking hazard to children.

    Product
    Contigo Kids Cleanable Water Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Food)·F-0679-2020·2020-02-19

    Worldwide Seafood Products Recalls Tidal Seafood Yellowfin Tuna for Histamine Levels

    Worldwide Seafood Products LLC is recalling Tidal Seafood Yellowfin Tuna due to potentially elevated histamine levels. The product was distributed domestically to one consignee.

    Product
    103200 - TIDAL SEAFOOD YELLOWFIN TUNA 10 lb, 2x10 lb cases and 103205 - TIDAL SEAFOOD YELLOWFIN TUNA 10 lb, 2x10 lb packed by Truong Phu Xanh Co. Ltd., in Vietnam
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1126-2020·2020-02-19

    Implant Direct Sybron Recalls Dental Implants With Incorrect Color Coding

    Implant Direct Sybron Manufacturing LLC is recalling 11 dental implant units because the vial and cap colors did not match the implant size, potentially causing surgical delays or infection risks.

    Product
    SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1207-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1121-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms for valve system issues.

    Product
    Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2020·2020-02-19

    Terumo Advanced Perfusion Assembly Pump Guts Recalled for Potential Shaft Failure

    Terumo is recalling 16 Advanced Perfusion Assembly Pump Guts units because the pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2020·2020-02-19

    Flowonix US Clinical 20mL Programmable Pump Recall for Firmware Alarm Defect

    Flowonix Medical Inc is recalling US Clinical 20mL Programmable Pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2020·2020-02-19

    Terumo AZUR CX Peripheral Coil System Recalled for Missing Implant Coil

    Microvention is recalling 1,187 units of Terumo AZUR CX Peripheral Coil Systems because the implant coil may be missing from the packaging.

    Product
    Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, Sterile, Rx. The…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1125-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms.

    Product
    Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V089000·2020-02-14

    Mercedes-Benz Recalls Vehicles for Instrument Cluster Software Defect

    Mercedes-Benz is recalling specific 2020-2021 models because instrument cluster software may deactivate interior switch illumination, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450, CLA 250, GLS450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V084000·2020-02-13

    Heartland Recalls 2020 Fifth Wheel Trailers Due to Smoke Detector Placement

    Heartland is recalling 487 fifth wheel trailers because a smoke detector may be incorrectly located in the bedroom, potentially delaying fire warnings.

    Product
    HEARTLAND — HEARTLAND MILESTONE, PIONEER, BIGHORN TRAVELER, ELKRIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V081000·2020-02-13

    Jaguar Recalls 2010 XF Vehicles Due to Fuel Leak Fire Risk

    Jaguar is recalling 2010 XF vehicles with 4.2L engines because a cracked fuel tank outlet flange may leak fuel, increasing fire risk.

    Product
    JAGUAR — JAGUAR XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V083000·2020-02-13

    BMW Recalls 2019 C 400 X Scooters for Throttle Cable Defect

    BMW is recalling 2019 C 400 X scooters because water in the throttle cable can freeze, causing the throttle to stick and increasing crash risk.

    Product
    BMW — BMW C 400 X
    Category
    Vehicle
    Distribution
    Distributed nationwide