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.

22951–22975 of 50430

  • HighFDA (Devices)·Z-2171-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0992-2020·2020-06-10

    Plucker's Wing Bar Teriyaki Sauce Recalled for Undeclared Wheat

    Zilks Foods is recalling Plucker's Wing Bar Teriyaki Sauce due to potential undeclared wheat. The product was distributed in Texas and Louisiana.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Teriyaki 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2224-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M6540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0987-2020·2020-06-10

    Plucker's Wing Bar Gochujang Sauce Recalled for Undeclared Wheat

    Zilks Foods is recalling 288 bottles of Plucker's Wing Bar Gochujang sauce in Texas and Louisiana due to potential undeclared wheat.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Gochujang 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2226-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number 810M7550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20134·2020-06-10

    Ushio America Recalls Indiglow LED T8 Lamps Due to Overheating Hazard

    Ushio America is recalling Indiglow LED T8 lamps because they can overheat and fall, posing an injury risk. Consumers should stop using them and contact the company for a refund or replacement.

    Product
    Indiglow LED T8 Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out post-operatively.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation System Implants

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws and post-operative backing out of the closure top.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number 810M7535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1287-2020·2020-06-10

    Teva Recalls Mixed Amphetamine Salts Tablets Due to Mixed Strengths

    Teva Pharmaceuticals USA is recalling 84,209 bottles of 20 mg Mixed Amphetamine Salts tablets because some bottles may contain mixed strengths.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2020·2020-06-10

    Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling 19,800 Gambro Cartridge Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.

    Product
    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation System Implants

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number 810M6550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2218-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2020·2020-06-10

    Intuitive Recalls 17 da Vinci SP Surgical Systems Due to Software Anomaly

    Intuitive Surgical is recalling 17 da Vinci SP surgical systems because a software anomaly may cause mechanical vibration of instrument tips and the endoscope under rare conditions.

    Product
    da Vinci SP surgical system
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2259-2020·2020-06-10

    GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect

    GE Healthcare is recalling 526 Discovery NM 530c systems because outdated software caused a patient finger injury during an automatic unload process.

    Product
    System, Tomography Computed Emmission
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2196-2020·2020-06-10

    Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling 4,065 Gambro Cartridge Low Weight-Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.

    Product
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20132·2020-06-10

    Island Wear Recalls Umbrella Strollers Due to Fall and Choking Hazards

    Island Wear is recalling about 940 umbrella strollers sold in Ocean City, Md., because they violate federal safety standards, posing fall and choking risks to children.

    Product
    Umbrella strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0975-2020·2020-06-10

    Dragonfly Galanga Powder Recalled for Lead Contamination

    U.S. Tov, Inc. is recalling Dragonfly brand Galanga Powder because testing by the New York State Dept of Agriculture and Markets found it contains lead.

    Product
    Dragonfly brand Galanga Powder; Net Weight: 5 oz. (142 g) UPC: 7 21557 53337 6 Product of Thailand Distributed by U.S. Trading Company, Hayward, CA 94545-1130
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0990-2020·2020-06-10

    Plucker's Wing Bar Sesame Wing Sauce Recalled for Undeclared Wheat

    Zilks Foods is recalling 180 bottles of Plucker's Wing Bar Sesame Wing Sauce sold in Texas and Louisiana due to potential undeclared wheat.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Sesame 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states