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.

20676–20700 of 50413

  • HighFDA (Devices)·Z-1344-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 2,466 Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2021·2021-04-14

    Beckman Coulter MicroScan WalkAway-40 Plus Reconditioned Instruments Recalled

    Beckman Coulter is recalling six reconditioned MicroScan WalkAway-40 Plus instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighCPSC·21109·2021-04-14

    Battat Recalls Firefly Frank Infant Teethers Due to Choking Hazard

    Battat is recalling B. toys Firefly Frank infant teethers sold at Target because plastic wings can detach, posing a choking hazard to young children.

    Product
    B. toys Firefly Frank Infant Teethers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2021·2021-04-14

    ROi CPS Recalls Regard Custom Cardiovascular Procedure Kits

    ROi CPS LLC is recalling 16 Regard custom cardiovascular procedure kits because drape slits may breach the sterile barrier.

    Product
    Regard, Item Number 830067009, custom cardiovascular procedure kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 24 units of Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2021·2021-04-14

    Siemens Ysio X.pree Digital X-Ray System Recalled for Image Mismatch

    Siemens is recalling 12 Ysio X.pree digital X-ray systems because a software issue may display a previous patient's image during recovery, potentially impacting diagnosis.

    Product
    Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-40 plus Instruments

    Beckman Coulter is recalling 16 MicroScan WalkAway-40 plus instruments because a shortened reagent straw may cause reagent dispensing failures, leading to organism misidentification or quality control failures.

    Product
    MicroScan WalkAway-40 plus Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighCPSC·21110·2021-04-14

    Audio-Technica Recalls Wireless Headphone Charging Cases Due to Fire Hazard

    Audio-Technica is recalling charging cases for ATH-CK3TW wireless headphones because they can overheat and pose a fire hazard. No injuries have been reported.

    Product
    Charging Cases Sold with Audio-Technica Wireless Headphones, Model ATH-CK3TW
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2021·2021-04-14

    BD BBL Martin-Lewis Agar Recalled for Misformulation and Fungal Growth

    Becton Dickinson is recalling BD BBL Martin-Lewis Agar due to misformulation causing heavy fungal growth, which may delay the diagnosis of Neisseria infections.

    Product
    BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0388-2021·2021-04-14

    B&G Sweet Heat Pepper Dip Recalled for Undeclared Milk Allergen

    B&G Sweet Heat Peppers is recalling 43 cases of Sweet Heat Pepper Dip because the label fails to declare milk, despite containing cream cheese and sour cream.

    Product
    B&G Sweet Heat Pepper Dip, Ready To Eat, Refrigerated, packaged in 10 oz, semi-rigid plastic container. UPC 7 42832 07566 4. Product label is read in parts: "***SWEET HEAT PEPPER DIP ***Ingredients: Cream Cheese, Sour Cream, Jalapenos, Sugar, Apple Cider Vinegar, Granulated…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1369-2021·2021-04-14

    Hologic Recalls Panther Fusion Tube Trays Due to Potential Leakage

    Hologic is recalling 1,355 Panther Fusion Tube Trays because they may leak, potentially causing false positive, false negative, or invalid patient results.

    Product
    Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2021·2021-04-14

    Fujifilm Synapse PACS Recalled for Potential Wrong Patient Information Display

    Fujifilm Medical Systems is recalling Synapse PACS software because it may display incorrect patient information in the viewer or PowerJacket.

    Product
    Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-96 plus Reconditioned Instruments

    Beckman Coulter is recalling nine MicroScan WalkAway-96 plus Reconditioned Instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-96 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1368-2021·2021-04-14

    Medtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation

    Medtronic is recalling A610 Clinician Programmer software versions 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057 due to software errors that prevent proper copying of cycling settings and cause application crashes when reading full system event logs.

    Product
    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2021·2021-04-14

    Terumo Sternal Retractor Locking Mechanism Recall for Fracture Risk

    Terumo is recalling 12 sternal retractor devices because the stainless steel locking plates may fracture. The devices were distributed in eight US states.

    Product
    Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V262000·2021-04-13

    Kenworth Recalls 2022 Trucks Due to Starter Interlock Defect

    PACCAR is recalling 2022 Kenworth T440, T470, T800, and W900 trucks because the starter interrupt may allow starting when the transmission is not in PARK.

    Product
    KENWORTH — KENWORTH T800B, W990, T440, T470
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V259000·2021-04-13

    2021 KIA SELTOS Engine Defect May Cause Stall or Fire

    Kia is recalling 2021 Seltos and 2020-2021 Soul vehicles due to improperly heat-treated piston rings that may cause engine damage, stalling, and crash risk, or oil leaks that may cause fires.

    Product
    KIA — KIA SOUL, SELTOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V261000·2021-04-13

    Tropos Recalls 2019 ABLE ST Vehicles for Speed Limit Defect

    Tropos is recalling 2019 ABLE ST vehicles because the motor controller firmware may allow speeds over 25 mph, violating federal safety standards.

    Product
    TROPOS — TROPOS ABLE ST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V254000·2021-04-12

    Palfinger Roll-Off and Hoist Recall for Tarp Arm Fatigue Failure

    Omaha Standard is recalling 2019-2021 Palfinger American Roll-Off, Cable Hoist, and Hook Lift units because welded gusset fatigue may cause tarp arms to break.

    Product
    PALFINGER — PALFINGER AMERICAN ROLL OFF, CABLE HOIST, HOOK LIFT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V253000·2021-04-12

    Blue Bird Recalls 2018-2021 School Buses for Electrical Fault Detection Issue

    Blue Bird is recalling 2018-2021 Vision and All American school buses because the electric drive train may fail to detect high-voltage isolation faults, posing a shock risk to service personnel.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS, ALL AMERICAN, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-04102021·2021-04-10

    USDA Issues Public Health Alert for Raw Ground Turkey Linked to Salmonella

    USDA FSIS issued a public health alert for raw ground turkey products from Plainville Brands, LLC, linked to a multistate Salmonella Hadar outbreak.

    Product
    Plainville Farms — FSIS Issues Public Health Alert for Raw Ground Turkey Products Linked to Salmonella Hadar Illness
    Category
    Food
    Distribution
    Distributed nationwide