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.

26926–26950 of 50462

  • HighFDA (Devices)·Z-0452-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Issue

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2019·2018-11-21

    GE Healthcare Recalls Aisys Anesthesia Systems for Missing Backup Ventilation Feature

    GE Healthcare is recalling Aisys anesthesia systems because a software upgrade prevents the device from automatically switching to backup ventilation if a patient stops breathing.

    Product
    Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold 18x22cm devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0461-2019·2018-11-21

    Medtronic Recalls Parietex Composite Parastomal Mesh Due to Failure Reports

    Medtronic is voluntarily removing Parietex Composite Parastomal Mesh from the market after receiving reports of product failure leading to hernia recurrence.

    Product
    Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold 20x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.

    Product
    OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0454-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0433-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0412-2019·2018-11-21

    GE Healthcare Recalls Aisys Anesthesia Systems Due to Ventilation Mode Defect

    GE Healthcare is recalling Aisys anesthesia systems because they may fail to transition to backup ventilation if a patient stops breathing spontaneously.

    Product
    Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold 4x8cm devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0439-2019·2018-11-21

    Stryker Spirit Select Bed Recall for Potential Entrapment Risk

    Stryker is recalling Spirit Select Beds with high rail siderails due to non-compliance with safety standards and a potential risk of entrapment.

    Product
    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
    Category
    Medical Device
    Distribution
    50 states
  • HighNHTSA·18V822000·2018-11-20

    RAM Recalls 2019 1500 Trucks for Passenger Seat Sensor Defect

    Chrysler is recalling 2019 RAM 1500 trucks because a loose passenger seat sensor may prevent proper airbag deployment, increasing injury risk in a crash.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V820000·2018-11-20

    Cruiser RV Recalls 2019 MPG and Radiance Ultra Lite Trailers

    Cruiser RV is recalling 2019 MPG and Radiance Ultra Lite trailers because inner hub bearings may overheat and fail, increasing crash risk.

    Product
    CRUISER RV — CRUISER RV RADIANCE ULTRA LITE, MPG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19718·2018-11-20

    HoMedics Recalls Giraffe Nightlights Due to Choking Hazard

    HoMedics is recalling MyBaby Giraffe Nightlights because small feet can detach, posing a choking hazard to small children.

    Product
    MyBaby Giraffe Nightlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·115-2018·2018-11-19

    Deleite Foods Recalls Marinated Chicken Thigh Meat Due to Undeclared Allergens

    Deleite Foods Enterprises is recalling approximately 11,000 pounds of marinated raw chicken thigh meat because the labels fail to declare wheat and soy allergens.

    Product
    Deleite Foods Enterprises, Inc. Recalls Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·18T016000·2018-11-19

    Yokohama Recalls RY023 Tires Due to Tread Separation Risk

    Yokohama is recalling specific RY023 tires because the rubber compound may be incorrect, potentially causing the tread to separate from the casing and increasing the risk of a crash.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18E105000·2018-11-16

    IMT Omnex Wireless Transmitters Recalled for Unintended Crane Movement

    Iowa Mold Tooling Co. is recalling Omnex Proportional Wireless Transmitters because a failing diode may cause cranes to move unexpectedly, increasing injury risk.

    Product
    ELECTRICAL SYSTEM recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V812000·2018-11-16

    Thor Motor Coach Recalls 2017-2019 Motorhomes for Windshield Shade Defect

    Thor Motor Coach is recalling 2017-2019 Challenger, Miramar, and Outlaw motorhomes because the driver's windshield roller shade may unroll unexpectedly, blocking visibility.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH OUTLAW, CHALLENGER, MIRAMAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19716·2018-11-15

    LÍLLÉbaby Recalls Active Series Baby Carriers Due to Fall Hazard

    LÍLLÉbaby is recalling about 6,600 Active Series baby carriers because a sliding chest-clip strap can detach, posing a fall hazard to the child.

    Product
    Active Series baby carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V808000·2018-11-15

    Wabash National Van Trailers Recalled for Detaching Limb Deflectors

    Wabash is recalling 2014-2019 Van trailers because limb deflectors may detach while moving, increasing crash risk. Dealers will remove the parts free of charge.

    Product
    WABASH NATIONAL — WABASH NATIONAL VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0403-2019·2018-11-14

    Request Foods Recalls Beecher's Enchilada Bowls for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Beecher's Enchilada Bowl Verde due to potential contamination with Listeria monocytogenes and Salmonella.

    Product
    Beecher's Enchilada Bowl Verde 9oz. UPC 82045 11382 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0373-2019·2018-11-14

    ALDI Fit & Active Southwest Veggie Stuffed Sandwiches Recalled for Contamination

    J&J Snack Foods is recalling ALDI Fit & Active Southwest Veggie Stuffed Sandwiches because the vegetables used may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Fit & Active Southwest Veggie Stuffed Sandwiches NET WT 9 oz (255 g) KEEP FROZEN Distributed by ALDI Inc. Batavia, IL 60510 UPC 0 41498 15117 1
    Category
    Food
    Distribution
    7 states