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.

26601–26625 of 50462

  • HighFDA (Devices)·Z-0772-2019·2019-01-30

    Leica M220 F12 Surgical Microscope Recalled for Falling Optics Hazard

    Leica Microsystems is recalling 15 Leica M220 F12 surgical microscopes because the optics may drop into the surgical field, risking contact with the patient.

    Product
    Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2019·2019-01-30

    Stihler PRISMAFLO II S Blood Return Warmer Recalled for Burn Risk

    Stihler Electronic Gmbh is recalling PRISMAFLO II S blood return warmers because damage to the heating profile may cause low-level skin burns.

    Product
    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2019·2019-01-30

    Fetzer Medical Recalls Obstetrical Forceps Due to Functional Defect

    Fetzer Medical is recalling 174 units of Luikart Simpson OB Forceps because doctors reported being unable to pull the instruments apart.

    Product
    16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0385-2019·2019-01-30

    Bound Tree Medical Recalls Curaplex Epi Safe Training Kits Due to Labeling Errors

    Bound Tree Medical is recalling 2,654 Curaplex Epi Safe training kits because the instructions recommend an unapproved epinephrine dosage for young children.

    Product
    Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2019·2019-01-30

    Stihler PRISMAFLO II S Blood Return Warmer Recalled for Burn Risk

    Stihler Electronic Gmbh is recalling PRISMAFLO II S blood return warmers because damage to the heating profile may cause low-level skin burns.

    Product
    Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2019·2019-01-30

    Fetzer Medical Recalls Simpson OB Forceps Due to Functional Defect

    Fetzer Medical is recalling 2 units of Simpson OB Forceps because doctors reported being unable to pull the instruments apart.

    Product
    12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order…
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·19V057000·2019-01-28

    Audi Recalls 2013-2016 A8 and S8 Models for Fuel Leak Risk

    Volkswagen Group of America is recalling 2013-2016 Audi A8 and S8 vehicles because a fuel supply line may leak, increasing the risk of fire.

    Product
    AUDI — AUDI S8, A8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V054000·2019-01-24

    Mack Trucks Recalls 2019-2020 Models Due to Detaching Mirror Risk

    Mack Trucks is recalling 2019-2020 Anthem, Granite, and Pinnacle vehicles because the passenger-side door mirror may detach, posing a risk of injury or crash.

    Product
    MACK — MACK ANTHEM (AN), PINNACLE (PI/PN), PINNACLE (CHU), GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V052000·2019-01-24

    Acura Recalls 2014-2019 ILX Vehicles for Fuel Tank Defect

    Acura is recalling 2014-2019 ILX vehicles because a deformed fuel tank may cause the fuel gauge to display inaccurate levels, potentially leading to stalling and crashes.

    Product
    ACURA — ACURA ILX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2019·2019-01-23

    Arthrex Suture Anchor Recall Due to Potential Breakage During Insertion

    Arthrex is recalling Nano Corkscrew FT Suture Anchors because they may break during insertion. The recall covers 1,418 units distributed in the US and abroad.

    Product
    Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2019·2019-01-23

    Kimberly-Clark Recalls U by Kotex Sleek Tampons for Structural Defect

    Kimberly-Clark is recalling U by Kotex Sleek tampons because they may come apart upon removal. The recall covers 68,852,076 units distributed nationwide and in Canada.

    Product
    U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2019·2019-01-23

    Zimmer Biomet Recalls Maximum Variable Pitch Compression Screw Caddy

    Zimmer Biomet is recalling 971 Maximum Variable Pitch Compression Screw Caddies due to a potential for silicone shedding during cleaning and sterilization.

    Product
    Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0730-2019·2019-01-23

    Smith & Nephew Recalls SL Plus Mia Double Offset Adapter Units

    Smith & Nephew is recalling 72 units of the SL Plus Mia Double Offset Adapter because a pin may not be properly mounted and could disassemble.

    Product
    SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0749-2019·2019-01-23

    U by Kotex Sleek Regular Tampons Recalled for Potential Breakage

    Kimberly-Clark is recalling U by Kotex Sleek Regular Tampons because they may come apart upon removal.

    Product
    U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2019·2019-01-23

    Zimmer Biomet Recalls Compression Tray Bases Due to Silicone Shedding

    Zimmer Biomet is recalling 971 Maximum Variable Pitch Compression Tray Bases because they may shed silicone during cleaning and sterilization.

    Product
    Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2019·2019-01-23

    Meridian Premier Cryptococcal Antigen Test Recalled for Stability Issues

    Meridian Bioscience is recalling Premier Cryptococcal Antigen kits because an enzyme reagent may not maintain stability, potentially causing false negative results.

    Product
    PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2019·2019-01-23

    Waldemar Link LINK STEM Reconstruction Prosthesis Recalled for Depth Defect

    Waldemar Link is recalling 11 LINK STEM Reconstruction Prostheses because a manufacturing defect prevents the reaming guide from reaching the intended depth, which may lead to incorrect surgical positioning.

    Product
    LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0745-2019·2019-01-23

    Bayer Medical Care Recalls MAVIG Portegra Overhead Counterpoise Systems

    Bayer Medical Care is recalling MAVIG Portegra and Portegra2 Overhead Counterpoise Systems because the head mount knob may not be properly tightened, causing the injector head to become loose or fall.

    Product
    MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2019·2019-01-23

    Conformis iTotal Hip Replacement System Reamed with Incorrect Interference Fit

    Conformis, Inc. is recalling one iTotal Hip Replacement System because the reamer instruments used had a -1mm interference fit instead of the expected -2mm.

    Product
    iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
    Category
    Medical Device
    Distribution
    1 state