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.

17951–17975 of 50404

  • HighFDA (Devices)·Z-0668-2022·2022-03-02

    Collagen Dura Substitute Membrane Recalled for Compromised Sterility

    Collagen Matrix is recalling 68 units of DuraMatrix-Onlay Collagen Dura Substitute Membrane due to unsealed outer packaging that may compromise product sterility and increase infection risk.

    Product
    DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2022·2022-03-02

    Biomet Shoulder Stem Implants Recalled for Coating Adhesion Defect

    Biomet is recalling certain shoulder stem implants due to potential insufficient adhesion strength in the porous plasma coating. An improper rework process may have compromised the coating's integrity.

    Product
    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0660-2022·2022-03-02

    Optima Coil System Recalled for Labeling and Packaging Mix-Up

    BALT USA recalls Optima Coil System embolization devices due to labeling/pouch mix-up that could result in incorrect device selection during surgical procedures. Potential harms include vessel damage and aneurysm rupture.

    Product
    The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2022·2022-03-02

    Bard Surestep Intermittent Catheter Tray Recalled for Connection Leaks

    C.R. Bard Inc recalled 1,620 units of Bard Surestep Intermittent Catheter Tray because the catheter may leak where it connects to the drain bag. No injuries have been reported.

    Product
    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0674-2022·2022-03-02

    Comprehensive Shoulder System Mini Humeral Stem Recalled for Coating Adhesion Defect

    Biomet recalls 11 units of its Comprehensive Shoulder System Mini Humeral Stem due to potential coating adhesion defects. An unvalidated rework process was applied to vendor-coated parts, risking implant failure.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22090·2022-03-02

    ALDI Bee Happy Advent Calendars Recalled for Excessive Lead Paint

    ALDI is recalling Bee Happy 12 Days of Craft Advent Calendars due to lead paint on a brown bell in Day 10 that exceeds the federal lead paint ban. The product poses a risk of lead poisoning if the paint is ingested, particularly for young children.

    Product
    Bee Happy 12 Days of Craft Advent Calendars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0666-2022·2022-03-02

    Bard SureStep Intermittent Catheter Tray recalled for potential leak defect

    C.R. Bard is recalling 2,120 units of the BARD SURESTEP INTERMITTENT CATHETER TRAY (14Fr) due to a potential leak at the catheter-to-drain-bag connection.

    Product
    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0740-2022·2022-03-02

    EpiGenius Kids Chocolate Superfood Recalled for Undeclared Milk

    Organic By Nature, Inc. is recalling Purim Health Brands EpiGenius Kids Chocolate: Daily Superfood pouches due to undeclared milk in an MCT powder ingredient. The product poses a risk to consumers with milk allergies.

    Product
    Purim Health Brands EpiGenius Kids Chocolate: Daily Superfood 630 g pouches Suggested Use: Mix approximately three tablespoons with 8-10 ounces of cold water. Shake vigorously or blend. For a creamier texture, mix with your favorite non-diary milk or in smoothie. This delicious…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0657-2022·2022-03-02

    Medtronic Endurant Stent Graft Systems: Taper Tip Detachment Risk

    Certain Medtronic Endurant stent graft systems may have taper tips that detach from the delivery system during implant procedures, potentially requiring secondary surgical intervention.

    Product
    Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0664-2022·2022-03-02

    Stryker Color Cuff tourniquet cuff mislabeled as single-bladder when dual-bladder

    Stryker Sustainability Solutions is recalling 40 units of Color Cuff 18" tourniquet cuffs (Lot #12983349) because they are mislabeled as single-bladder when they are actually dual-bladder, creating a risk of incorrect clinical use.

    Product
    REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0675-2022·2022-03-02

    Biomet Shoulder Implant Stem Coating Adhesion Defect Recall

    Biomet is recalling shoulder implant stems due to improper rework of porous plasma coating, which may lack sufficient adhesion strength. Affected units may fail if the coating detaches.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0741-2022·2022-03-02

    Arillis Tortillas Recalled Due to Undeclared Wheat Allergen

    Arillis Corp is recalling Tortillas Arillis due to undeclared wheat. Consumers with wheat allergies may be at risk if they consume the product.

    Product
    Tortillas Arillis, Arillis Corp, Contains: 10 (ten) tortillas
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0801-2022·2022-03-02

    Diastatic Malt Powder Recalled Due to Potential Salmonella Contamination

    Malt Products Corporation is recalling approximately 3,015 bags of Diastatic Malt Powder due to potential Salmonella contamination. The affected product was distributed to multiple states; consumers should not consume it.

    Product
    Diastatic Malt Powder 50lb bag - up to 50 bags per pallet Malt Products Corporation
    Category
    Food
    Distribution
    14 states
  • HighUSDA FSIS·PHA-03012022-01·2022-03-01

    Ready-to-Eat Meat Products Recalled for Undeclared Wheat Allergen

    USDA FSIS issued a public health alert for ready-to-eat meat products containing a seasoning mix with undeclared wheat. Consumers are advised not to consume these items.

    Product
    FSIS Issues Public Health Alert for Ready-to-Eat Meat Products Containing FDA-Regulated Seasoning Mix That Has Been Recalled Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·22V116000·2022-03-01

    Pierce Arrow XT Firetruck Recall for Improperly Crimped Lifting Cables

    Pierce Manufacturing is recalling one 2021 Arrow XT firetruck because improperly crimped lifting cables could cause the generator set to fall, increasing injury risk.

    Product
    PIERCE — PIERCE ARROW XT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V114000·2022-02-28

    Proterra buses recalled for loose steering gearbox securing bolts

    Proterra is recalling 2017-2022 Catalyst and ZX5 buses because steering gearbox securing bolts may loosen due to insufficient adhesive, risking loss of steering control. Owner notifications were sent October 7, 2022.

    Product
    PROTERRA — PROTERRA ZX5, CATALYST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V107000·2022-02-24

    2021 Toyota C-HR: Inoperative Radar Sensor Disables Collision Avoidance

    Certain 2021 Toyota C-HR vehicles have a radar sensor that was not activated during production, disabling the pre-collision system and forward collision avoidance. Dealers will activate the sensor at no cost.

    Product
    TOYOTA — TOYOTA C-HR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22731·2022-02-24

    Kelly Wynne Children's Handbags Recalled for Excess Lead Content

    Kelly Wynne is recalling about 1,050 Mama & Me MINI children's handbags sold online from July 2020 through October 2021 because metal components contain lead levels that exceed the federal ban. No injuries have been reported.

    Product
    Mama & Me MINI Children's Handbags
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V110000·2022-02-24

    Yamaha Recalls 2021 Tracer 9 GT Motorcycles Due to Throttle Grip Defect

    Yamaha is recalling 453 2021 Tracer 9 GT motorcycles because the throttle grip may break if used to lift the bike, potentially causing loss of throttle control and a crash.

    Product
    YAMAHA — YAMAHA TRACER 9 GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V111000·2022-02-24

    Missing Mounting Bolt in 2022 INFINITI QX60 Second-Row Seat Track

    Nissan is recalling 2022 INFINITI QX60 vehicles because the second-row seat track may be missing a mounting bolt. This could allow the seat track to move during a crash, increasing injury risk.

    Product
    NISSAN — NISSAN, INFINITI PATHFINDER, QX60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2022·2022-02-23

    Philips Zenition 70 Wireless Foot Switch Firmware Failure Recall

    Philips is recalling Zenition 70 wireless foot switches due to a firmware issue that can cause the device to stop responding. This could interrupt imaging procedures if alternative controls are not used.

    Product
    Zenition 70, Model #718133
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0644-2022·2022-02-23

    Howmedica Osteonics Medical Device Packaging Defect: Tyvek Lid De-bonding Recall

    Howmedica Osteonics is recalling medical devices because the outer Tyvek lid may separate from the package seal. This affects 32MM -4 V40 TAPER VIT HEAD devices distributed worldwide.

    Product
    32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0734-2022·2022-02-23

    Organic Roasted Salted Cashews Recalled for Mislabeled Hazelnuts

    Honey Heaven Wholesale Inc is recalling Organic Roasted Salted Cashews because the product contains hazelnuts but is labeled as cashews. Hazelnuts are visible through the package window.

    Product
    Organic Roasted Salted Cashews, Net Weight of 6 oz (170g), UPC 6 16316 76283 1. Product is packed in a brown kraft stand-up paper pouch with plastic front viewing window with a zip-lock top that was heat sealed to close. The labeled cashew package has the ingredient…
    Category
    Food
    Distribution
    3 states