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.

23476–23500 of 50435

  • HighFDA (Devices)·Z-1521-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 628 custom procedure trays because they contain surgical gowns that may not be sterile. This poses a risk of surgical site infection and cross-contamination.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1502-2020·2020-03-25

    Agfa DR 800 X-Ray System Recalled for Tomosynthesis Sequence Error

    Agfa N.V. is recalling two DR 800 X-ray systems because the tomosynthesis image acquisition sequence did not stop automatically after the expected number of exposures.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,906 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1524-2020·2020-03-25

    Medtronic CareLink 2090 Programmer Recalled for Cyber Vulnerabilities

    Medtronic is recalling 23,180 CareLink 2090 Programmer devices worldwide due to improper access control and cleartext transmission of sensitive information.

    Product
    Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V178000·2020-03-25

    Thor Motor Coach motorhomes recalled for faulty rear axle differential

    Thor Motor Coach is recalling certain 2020-2021 motorhomes due to insufficient rear axle differential fluid that could cause driveshaft separation and loss of vehicle drive, increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH VEGAS, AXIS, CHATEAU, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2020·2020-03-25

    LivaNova Heater-Cooler System 3T Recalled for NTM Contamination Risk

    LivaNova is recalling Heater-Cooler System 3T units to reduce the risk of NTM contamination by providing validated cleaning and disinfection instructions.

    Product
    LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Containing Non-Sterile Gowns

    Avid Medical is recalling 2,632 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1497-2020·2020-03-25

    Siemens Artis Angiography Systems Recalled for Software Movement Blockage

    Siemens is recalling Artis angiography systems because a software issue could block stand and table movements.

    Product
    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,644 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1480-2020·2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus knee implant components because low-density polyethylene particles may be present on the surface when the packaging is opened.

    Product
    COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0837-2020·2020-03-25

    Dreyers Outshine Strawberry Fruit Bars Recalled for Plastic Contamination

    Dreyers Grand Ice Cream is recalling Outshine Strawberry Fruit Bars due to consumer complaints of white plastic pieces.

    Product
    Outshine Fruit Bars Strawberry; 6 Fruit Ice Bars; 14.7 Fl. oz. (435 mL) UPC: 041548610047 Case UPC: 10041548610044
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-1519-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 230 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1514-2020·2020-03-25

    Siemens IMMULITE 2000 Estradiol Test Kits Recalled for High Discordant Results

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol test kits due to high discordant results that may lead to misinterpretation of patient menopausal status.

    Product
    IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2020·2020-03-25

    Boston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software

    Boston Scientific is recalling one DYNAGEN EL ICD DR device because a software update downloaded unapproved applications to four programmers.

    Product
    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2020·2020-03-25

    Siemens Artis Q Angiography Systems Recalled for Software Movement Issue

    Siemens is recalling Artis Q angiography systems because a software issue could block stand and table movements.

    Product
    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 5,004 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1501-2020·2020-03-25

    Siemens Ysio X-Ray System Recalled for Unexpected Tube Stand Movement

    Siemens is recalling Ysio X-Ray systems because a software error may cause the ceiling tube stand to move unexpectedly when activated by the user.

    Product
    Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V179000·2020-03-25

    Gillig Recalls 2012-2020 Low Floor Buses Due to Fire Risk

    Gillig is recalling 8,224 Low Floor buses because improper circuit breaker ratings may increase the risk of a fire.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2020·2020-03-25

    TeDan Surgical Recalls 3COR Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.

    Product
    D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1515-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 21,326 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1481-2020·2020-03-25

    Aesculap Recalls Knee Implant Components Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low-density polyethylene particles may be present on the surface upon opening.

    Product
    AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2020·2020-03-25

    Aesculap Recalls Knee Implants Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low density polyethylene particles may be present on the surface.

    Product
    COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0838-2020·2020-03-25

    Outshine Pineapple Fruit Bars Recalled for White Plastic Pieces

    Dreyers Grand Ice Cream is recalling Outshine Pineapple Fruit Bars due to consumer complaints of white plastic pieces in the product.

    Product
    Outshine Fruit Bars Pineapple; 6 Fruit Ice Bars; 6x2 5 fl. oz) 14.7 Fl. oz. (435 mL); Package UPC: 041548750958; Case UPC: 10041548750955
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-1479-2020·2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus CR/PS Tibial Plateau knee implant components because low-density polyethylene particles may be present on the surface.

    Product
    COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,001 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states