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.

22126–22150 of 50429

  • HighFDA (Devices)·Z-2953-2020·2020-09-23

    Integra LifeSciences Recalls 13 ft Handpiece Cables for Dermatome Sets

    Integra LifeSciences is recalling 74 units of 13 ft handpiece cables used in dermatome sets because the cables melt after sterilization.

    Product
    13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V574000·2020-09-23

    Ford Recalls 2020 Expedition Vehicles for Seat Belt Sensor Defect

    Ford is recalling 2020 Expedition vehicles because the seat belt tension sensor may misclassify a child as an adult. This could cause the airbag to deploy in a crash, increasing injury risk.

    Product
    FORD — FORD EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V577000·2020-09-23

    2021 Airstream Basecamp Trailers Recalled for Incorrect Tire Placard Information

    Airstream is recalling certain 2021 Basecamp 16 trailers because the tire placard displays incorrect tire size and inflation pressure. If tires are inflated per the incorrect label, they could become dangerously underinflated, increasing crash risk.

    Product
    AIRSTREAM — AIRSTREAM BASECAMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2969-2020·2020-09-23

    Avanos MIC-KEY SF Gastrostomy Feeding Tube Recalled for Cracks

    Avanos Medical is recalling 284 units of MIC-KEY SF Gastrostomy Feeding Tubes because the devices had cracked or detached from the feeding tube body.

    Product
    AVANOS MIC-KEY SF Gastrostomy Feeding Tube
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2973-2020·2020-09-23

    Inpeco FlexLab Laboratory Automation System Recalled for Sample ID Errors

    Inpeco S.A. is recalling FlexLab laboratory automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed test results.

    Product
    FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2974-2020·2020-09-23

    Inpeco FlexLab 3.6 Automation Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling 8 FlexLab 3.6 Automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed clinical chemistry results.

    Product
    Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1603-2020·2020-09-23

    RLC Labs Recalls Nature-Throid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured under conditions associated with subpotency.

    Product
    Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3309-4; b) 60-count bottles, NDC 64727-3309-5; c) 90-count bottles, NDC 64727-3309-6; d) 100-count bottles, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1521-2020·2020-09-23

    Ponder Foods Recalls Sweet Chili Sauce for Undeclared Peanuts

    Ponder Foods is recalling Pretty Thai brand Sweet Chili Sauce because it may contain undeclared peanuts. The product was distributed in Texas.

    Product
    Pretty Thai brand Sweet Chili Sauce Net Wt 11.2 oz (317g) UPC 860043001224 packaged in a clear PET plastic bottle with a white label.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2954-2020·2020-09-23

    Integra Padgett Dermatome Set Recalled Due to Cable Melting

    Integra LifeSciences is recalling 13 dermatome sets because the handpiece cable melts after sterilization, posing a risk to patients and staff.

    Product
    Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1524-2020·2020-09-23

    Blue Apron Recalls Smoked Gouda Meal Kits Due to Salmonella Risk

    Blue Apron is recalling Smoked Gouda & Onion Burgers meal kits delivered the week of July 27, 2020, because the onions may be contaminated with Salmonella.

    Product
    Smoked Gouda & Onion Burgers with Corn on the Cob meal kits containing onions delivered the week of July 27, 2020.
    Category
    Food
    Distribution
    37 states
  • HighFDA (Devices)·Z-2960-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recall Due to Backwards Crimped Wire

    Terumo is recalling three Ultrasonic Air Sensors because a crimped wire was installed backwards, potentially causing false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2956-2020·2020-09-23

    Novarad Recalls NovaPACS Diagnostic Viewer Software Due to Image Placement Error

    Novarad Corporation is recalling NovaPACS Diagnostic Viewer software because the cross-localization feature may inaccurately place reference lines on asymmetrical images.

    Product
    NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1525-2020·2020-09-23

    Blue Apron Meal Kits Recalled Due to Salmonella Contamination Risk

    Blue Apron is recalling meal kits delivered the week of July 27, 2020, because the onions included may be contaminated with Salmonella.

    Product
    Carmelized Onion & Gouda Burgers with Creamy Mustard Dressed Corn on the Cob meal kits containing onions delivered the week of July 27, 2020.
    Category
    Food
    Distribution
    37 states
  • HighFDA (Food)·F-1509-2020·2020-09-23

    Fresco Foods Recalls Jackfruit Bowls Due to Undeclared Fish Allergen

    Fresco Foods is recalling Ancient Grain Jackfruit Bowls because the packaging failed to disclose the presence of anchovies, a fish allergen.

    Product
    Ancient Grain Jackfruit Bowl with Chickpeas & Edamame in a Thai Coconut Sauce, Eat Fresco, Keep Refrigerated, NET WT 14oz (397gr), Cook Thoroughly
    Category
    Food
    Distribution
    0 states
  • HighCPSC·20189·2020-09-23

    Caravan Sports Arm Bagged Chairs Recalled for Fall and Injury Hazards

    Caravan Global is recalling about 2,700 Sports Armed/Padded Arm Bagged Chairs sold at H-E-B stores in Texas due to a defect that can cause the seat to rip from the frame.

    Product
    Caravan Sports Armed/Padded Arm Bagged Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2020·2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    Product
    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and…
    Category
    Medical Device
    Distribution
    45 states
  • HighNHTSA·20V578000·2020-09-23

    MCI Recalls 2019 D45 CRT LE Coaches Due to Seat Belt Defect

    Motor Coach Industries is recalling 2019 D45 CRT LE coaches because seat belt retractors in the last row may not function, increasing injury risk in collisions.

    Product
    MCI — MCI D45 CRT LE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2961-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recalled for Intermittent Connection Defect

    Terumo is recalling two Ultrasonic Air Sensors because a manufacturing defect may cause intermittent connections and false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2979-2020·2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    Product
    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2972-2020·2020-09-23

    Imactis Patient Fiducial Recalled Due to Component Separation Risk

    Imactis is recalling Patient Fiducial components because they may separate from the body, potentially causing navigation inaccuracies or improper needle trajectory.

    Product
    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2966-2020·2020-09-23

    Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples

    Randox Laboratories is recalling 143 kits of the AM1054 Ammonia reagent because it shows a positive bias of up to 140 µmol/l on patient samples.

    Product
    AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2952-2020·2020-09-23

    Longhorn PrimeStore Molecular Transport Medium Tubes Recalled for Cyanide Risk

    Longhorn Vaccines and Diagnostic is recalling PrimeStore Molecular Transport Medium tubes because the solution may produce cyanide gas when exposed to bleach.

    Product
    PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of…
    Category
    Medical Device
    Distribution
    Distributed nationwide