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.

38076–38100 of 50506

  • HighFDA (Devices)·Z-2108-2015·2015-07-29

    FDA Recalls Devon Light Gloves for Sterility Compromising Defects

    The FDA is recalling specific lots of Devon Light Gloves because splits or holes may compromise sterility. The recall affects 559,108 kits distributed worldwide.

    Product
    Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2015·2015-07-29

    FDA Recalls Sure F!ex Reusable Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Sure F!ex reusable laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V476000·2015-07-29

    Ford Recalls 2015 Lincoln MKT Vehicles Missing Second Row Seats

    Ford is recalling 2015 Lincoln MKT vehicles delivered without second-row seats, creating a safety compliance issue and increased crash injury risk.

    Product
    LINCOLN — LINCOLN MKT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2015·2015-07-29

    GE Healthcare Precision RXi Digital System Monitor Suspension Recall

    GE Healthcare is recalling Precision RXi Digital systems because a monitor fell from its suspension, posing an injury risk to patients or operators.

    Product
    GE Healthcare Precision RXi Digital system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2015·2015-07-29

    FDA Recalls Non-Sterile Devon Light Gloves Due to Splits and Holes

    The FDA is recalling non-sterile Devon Light Gloves because they contain splits or holes that compromise sterility. The recall affects lots with numbers beginning 508xxxx or lower.

    Product
    NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5, s5i, and CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2015·2015-07-29

    Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk

    Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2102-2015·2015-07-29

    Stryker SelectCore Biopsy Device Recalled for Stylet Ejection Risk

    Stryker is recalling 55 units of the SelectCore Variable Throw Biopsy Device because the stylet may eject during use.

    Product
    Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2015·2015-07-29

    Maquet Magnus Hybrid OR Table Column Recalled for Collision Risk

    Maquet is recalling 12 Magnus Hybrid OR Table Columns due to a potential collision risk with the C-arm of the Siemens Artis Zeego Angiography System.

    Product
    Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2015·2015-07-29

    Philips Recalls GEMINI TF Big Bore CT/PET Systems Due to Software Defects

    Philips is recalling 44 GEMINI TF Big Bore CT/PET systems worldwide because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.

    Product
    GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling Volcano s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2858-2015·2015-07-29

    Marine Harvest Recalls Kirkland Signature Salmon Milano Due to Listeria Risk

    Marine Harvest is recalling Kirkland Signature Salmon Milano with Basil Pesto Butter due to potential Listeria monocytogenes contamination. The product was distributed in California, Arizona, and Nevada.

    Product
    Kirkland Signature Salmon Milano with Basil Pesto Butter approx 1.5 lbs. Packaged in a metal tray with plastic cover.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2178-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2176-2015·2015-07-29

    FDA Recalls American Medical Systems Fiber Stripper Tools Due to Sterilization Issues

    American Medical Systems is recalling Fiber Stripper tools because their cleaning and sterilization instructions do not meet FDA guidance for reusable medical devices.

    Product
    Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2015·2015-07-29

    Abbott ARCHITECT c8000 System Recalled for Tubing Leak Risk

    Abbott Laboratories is recalling five ARCHITECT c8000 systems because the tubing may not meet specifications and could leak.

    Product
    ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2015·2015-07-29

    Hitachi PROBEAT Proton Beam System Recalled for Radiation Delivery Issues

    Hitachi America is recalling three PROBEAT proton beam systems due to potential radiation delivery inconsistencies during system reboots.

    Product
    PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2146-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to…
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2106-2015·2015-07-29

    FDA Recalls Sterile Devon Light Gloves Due to Splits and Holes

    The FDA is recalling sterile Devon Light Gloves because splits or holes compromise their sterility. The recall covers 26,108,946 units distributed worldwide.

    Product
    Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2015·2015-07-29

    Mermaid Medical M-Biopsy Coaxial Introducer Needles Recalled for Plastic Debris

    Mermaid Medical A/S is recalling M-Biopsy Coaxial Introducer Needles due to the potential for small plastic pieces to be present in the luer of the cannula.

    Product
    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2121-2015·2015-07-29

    GE Healthcare Precision RXi 23A/32A Analog System Monitor Suspension Recall

    GE Healthcare is recalling Precision RXi 23A/32A Analog Systems because a monitor suspension failure could cause a monitor to fall and injure a patient or operator.

    Product
    GE Healthcare Precision RXi 23A/32A Analog System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2015·2015-07-29

    FDA Recalls Disposable EndoStat Fiber Strippers Due to Validation Deficiencies

    American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation…
    Category
    Medical Device
    Distribution
    51 states