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.

13001–13025 of 22165

  • HighFDA (Devices)·Z-0653-2024·2024-01-17

    Oscor Intro Catheter Introducer Kit: Compromised Sterile Barrier

    Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.

    Product
    Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0647-2024·2024-01-17

    Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise

    Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.

    Product
    Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0700-2024·2024-01-17

    VADER pedicle system torque wrench may not tighten implant screws correctly

    Icotec Ag is recalling VADER pedicle system torque wrenches (Catalog Number 42-702) because the torque limiting function may malfunction, potentially leaving nut screws insufficiently tightened during implant surgery. No injuries have been reported.

    Product
    VADER pedicle system, torque wrench, Catalog Number 42-702
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0709-2024·2024-01-17

    Ingomar Diced Tomatoes in Juice Recalled for Plastic Foreign Objects

    Ingomar Packing Co is recalling 3/4" diced tomatoes in juice sold in 55-gallon drums due to potential plastic contamination. Affected products were distributed to California, Washington, and Japan.

    Product
    3/4" Diced Tomatoes in Juice packed in 55 gallon metal drums
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0713-2024·2024-01-17

    Wheelchair Control Device Throttle Lever May Stick During Operation

    The Scoot Control R-net wheelchair attendant controller's throttle lever may stick and fail to return to neutral, potentially causing unwanted chair movement. A total of 129 units were distributed in Tennessee and Texas.

    Product
    Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0660-2024·2024-01-17

    Baxter Preveleak Surgical Sealant recall for inaccurate marketing brochure

    Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.

    Product
    Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2024·2024-01-17

    Townsend Design Custom SPRYSTEP Ankle-Foot Orthosis Recalled for Structural Failure Risk

    Townsend Design is recalling 248 units of CUSTOM SPRYSTEP ankle-foot orthotics for potential air pockets that could cause complete structural failure and loss of ankle support.

    Product
    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0672-2024·2024-01-17

    SPRYSTEP VECTOR KAFO ankle-foot orthosis recalled for structural failure risk

    The SPRYSTEP VECTOR KAFO custom ankle-foot orthosis is being recalled by Townsend Design due to air pockets that could cause complete structural failure.

    Product
    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0694-2024·2024-01-17

    SoClean 3 CPAP Cleaner Recalled Over Ozone Exposure Risk

    SoClean, Inc is voluntarily recalling 40,075 units of the SoClean 3 sleep equipment cleaner due to potential ozone gas exposure. The manufacturer is providing an updated user manual with safety instructions and a protective hose and mask adapter.

    Product
    SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2024·2024-01-17

    Vascu-Guard Peripheral Vascular Patch marketing materials contain inaccurate information

    Baxter Healthcare is recalling marketing materials for its Vascu-Guard Peripheral Vascular Patch because a cardiovascular surgery brochure contains inaccurate content conflicting with official Instructions for Use and Prescribing Information.

    Product
    Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0702-2024·2024-01-17

    H. Pylori Diagnostic Test Recalled Due to Incorrect Expiration Date Label

    Immunostics is recalling H. Pylori diagnostic test kits due to mislabeled expiration dates. Using the product after expiration may produce false positive, false negative, or invalid results.

    Product
    Detector H. Pylori, Catalog Number IHP-30
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0714-2024·2024-01-17

    Ambu aView 2 Monitor recalled for fire and burn hazard from oversized mounting screws

    Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.

    Product
    Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V844000·2024-01-12

    2020-2022 Honda CR-V Hybrid battery cable recall due to missing fuse

    Honda recalls 2020-2022 CR-V Hybrid vehicles whose 12-volt battery cable is missing a fuse on the power circuit, which can cause short circuits or overheating during crashes and increase the risk of fire or injury.

    Product
    HONDA — 2020 HONDA CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V842000·2024-01-12

    Audi Electric Vehicles Recalled for Fire Risk in Charging Cable

    Audi is recalling select 2019-2024 electric vehicles due to fire risk from overheating 220V/240V home charging cables. Owners should stop using the affected cables and switch to 110V charging or public stations until replacement cables with temperature sensors are supplied.

    Product
    AUDI — 2021 AUDI A8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V840000·2024-01-12

    2021-2023 Porsche Taycan Battery Short Circuit Fire Risk

    Porsche is recalling 2021-2023 Taycan models due to a potential short circuit in the high-voltage battery that increases the risk of fire. Owners should contact Porsche customer service at 1-800-767-7243 for free inspection and repair.

    Product
    PORSCHE — 2021 PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V841000·2024-01-12

    Multiple Porsche electric vehicles: 220V charging cable fire risk recall

    Porsche is recalling multiple electric vehicle models due to fire risk from overheating 220V/240V charging cables. Owners should not use these cables and should instead use 110V charging or public stations.

    Product
    PORSCHE — 2024 PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24078·2024-01-11

    Millions of New Age Furniture Tip Restraint Kits Recalled for Tip-Over and Entrapment Hazard

    Plastic New Age furniture tip restraint kits can break or become brittle, allowing anchored clothing storage units to detach and tip over, creating a hazard to children. Consumers should check manufacture dates and contact Alliance4Safety for free replacements.

    Product
    New Age Industries ("New Age") Furniture tip kits or tip restraints
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V827000·2024-01-11

    2025 Rivian R1S and R1T exterior lights may fail due to software

    Software in 2025 Rivian R1S and R1T vehicles may disable exterior lights when the Car Costume feature is activated, reducing visibility and increasing crash risk. Rivian released a free software update to fix the issue.

    Product
    RIVIAN — 2025 RIVIAN R1S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24081·2024-01-11

    Scout Kid's Bike Helmets Recalled for Head Injury Risk

    Retrospec is recalling Scout model kid's bike helmets due to inadequate impact protection that violates the federal safety regulation for bicycle helmets. About 72,000 units sold between February 2019 and March 2023 are affected.

    Product
    Scout Kid's Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0634-2024·2024-01-10

    External Drainage System Collection Bags Recalled for Sterility Assurance Issues

    Natus Medical Incorporated is recalling 2,686 units of External Drainage System Collection Bags due to incomplete bioburden testing that prevents sterility assurance. Healthcare facilities and patients should contact the manufacturer or their healthcare provider for guidance.

    Product
    External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0688-2024·2024-01-10

    Scratch PASTA Co Marinara Sauce Recalled for Unlabeled Milk Allergen

    Scratch PASTA Co Marinara Sauce is recalled because the label does not list milk as a common allergen, despite the product containing milk in its butter ingredient.

    Product
    Scratch PASTA Co MARINARA SAUCE NET WT. 24.5 oz glass jar Ingredients: San Marzano Plum Peeled Tomatoes, Onion, Butter (Cream, Natural Flavor) UPC 8 50053 68700 6 Scratch Pasta Company 2204 Bedford Avenue, Suite E Lynchburg, Virginia 24503
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0623-2024·2024-01-10

    Medtronic Protege GPS Stent System Recalled for Packaging Seal Defects

    Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.

    Product
    Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2024·2024-01-10

    Merit Maestro Microcatheter Sterility Recall, 717 Units Distributed Worldwide

    Merit Medical Systems is recalling 717 units of Merit Maestro Microcatheters because their sterility cannot be guaranteed. Non-sterile devices could introduce infection when used in medical procedures.

    Product
    Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0638-2024·2024-01-10

    Philips Trilogy Evo respiratory devices recalled for missing contraindication statement

    Philips recalled Trilogy Evo respiratory devices for missing contraindications in labeling. Devices lack warnings against use in pediatric patients under 10 kg and certain therapy modes, risking barotrauma and respiratory complications.

    Product
    Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA21
    Category
    Medical Device
    Distribution
    Distributed nationwide