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.

28401–28425 of 50488

  • HighFDA (Devices)·Z-2364-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The firm states the residue is biocompatible.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2362-2018·2018-07-11

    Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging bags.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2370-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0900-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2368-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling 510 M/L Taper Hip Prostheses distributed to Japan due to potential black residue in the packaging.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0896-2018·2018-07-11

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling specific lots of sterile fentanyl and bupivacaine admixture bags due to a potential for leakage that compromises sterility.

    Product
    Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2357-2018·2018-07-11

    FHC Depth Stop Adapter Recall for Lead Damage Risk

    FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter can damage implanted leads if over-tightened, requiring replacement.

    Product
    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
    Category
    Medical Device
    Distribution
    46 states
  • HighCPSC·18185·2018-07-10

    Ortovox Recalls Avalanche Transceivers Due to Software Error

    Ortovox is recalling about 20,000 avalanche transceivers because a software error may prevent them from transmitting survivor location data, delaying rescue efforts.

    Product
    Avalanche transceivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V446000·2018-07-05

    Entegra Recalls 2019 Motorhomes for Windshield Wiper Defect

    Entegra is recalling 2019 Emblem and Vision motorhomes because windshield wiper arms may lift at highway speeds, reducing visibility and increasing crash risk.

    Product
    ENTEGRA — ENTEGRA EMBLEM, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V449000·2018-07-05

    Jayco Recalls 2019 White Hawk Trailers Due to Ladder Screw Defect

    Jayco is recalling 2019 White Hawk recreational trailers because screws securing ladder steps may break, posing a fall risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V451000·2018-07-05

    Jayco Recalls 2018-2019 Motorhomes Due to Incorrect Cargo Capacity Label

    Jayco is recalling 2018-2019 Alante, Precept, Seneca, Redhawk, and Melbourne motorhomes because the cargo capacity label overstates limits, increasing crash risk.

    Product
    JAYCO — JAYCO PRECEPT, REDHAWK, ALANTE, SENECA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V445000·2018-07-05

    Jayco Recalls 2019 Alante and Precept Motorhomes for Wiper Defect

    Jayco is recalling 2019 Alante and Precept motorhomes because windshield wiper arms may lift at highway speeds, reducing visibility and increasing crash risk.

    Product
    JAYCO — JAYCO PRECEPT, ALANTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1587-2018·2018-07-04

    New Seasons Market Recalls Vegan Chocolate Almond Muffins for Allergen Labeling

    New Seasons Market LLC is recalling Vegan Chocolate Almond Muffins because the packaging fails to declare almonds as an ingredient.

    Product
    Vegan Chocolate Almond Muffin, 4-pack, packaged in a clear clamshell container, net wt. 13.6 oz., UPC 8 40600 10955 6
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2323-2018·2018-07-04

    St Jude Medical Recalls Promote Quadra ICDs for Security Firmware Update

    St Jude Medical is recalling Promote Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2018·2018-07-04

    St Jude Medical Recalls Fortify ICDs and CRT-Ds for Security Firmware Update

    St Jude Medical is recalling Fortify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access. Older devices may require permanent disabling of RF communication.

    Product
    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2018·2018-07-04

    Teleflex Universal Shears Recalled Due to Handle Melting During Sterilization

    Teleflex Medical Europe Ltd is recalling 573 units of Pilling Universal Shears because incorrect plastic was used for the handles, causing them to melt during sterilization.

    Product
    Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2018·2018-07-04

    Medtronic Model 53401 Pacemakers Recalled for Unexpected Power Reset

    Medtronic is recalling 1,108 Model 53401 temporary external pacemakers because they may revert to nominal settings during use due to an unexpected power on reset.

    Product
    Single Chamber Temporary External Pacemaker, Model 53401
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2285-2018·2018-07-04

    B. Braun Recalls Infusomat Space Pump IV Sets Due to Missing Filter

    B. Braun Medical is recalling 1,872 Infusomat Space Pump IV Sets because some units may lack the required air-eliminating filter.

    Product
    Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2291-2018·2018-07-04

    Exsurco Medical Recalls Amalgatome SD Coaxial Pneumatic Hoses

    Exsurco Medical is recalling 70 Amalgatome SD coaxial pneumatic hoses due to improper installation that may cause hose bursts or pressure loss.

    Product
    Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
    Category
    Medical Device
    Distribution
    5 states