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.

39701–39725 of 50506

  • HighFDA (Devices)·Z-0973-2015·2015-01-21

    Synthes Malleable C-Retractor Recalled Due to Potential Spring Corrosion

    Synthes, Inc. is recalling Malleable C-Retractors because the internal spring may corrode or fail, potentially transferring particles to patients and causing adverse tissue reactions or infection.

    Product
    Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0958-2015·2015-01-21

    Invivo Recalls Philips Expression MR200 MRI Patient Monitoring Systems

    Invivo Corporation is recalling 20 Philips Expression MR200 MRI Patient Monitoring Systems due to capacitor shorts that may cause electrical shock or loss of monitoring.

    Product
    Philips Expression MR200 MRI Patient Monitoring System.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0987-2015·2015-01-21

    Siemens ADVIA Chemistry XPT Software Recall for Result Overwrite Risk

    Siemens is recalling 7 ADVIA Chemistry XPT systems in Washington due to a software defect that may cause critical results to be overwritten.

    Product
    ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0979-2015·2015-01-21

    Philips CT Systems Recalled for Improper Vertical Motor Assembly

    Philips is recalling Brilliance and Ingenuity CT systems because improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.

    Product
    Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2015·2015-01-21

    GE Healthcare Recalls Discovery IGS 730 and 740 X-ray Systems

    GE Healthcare is recalling 24 Discovery IGS 730 and 740 angiographic X-ray systems due to a user interface issue that may cause unintentional system motion or rotation.

    Product
    GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0952-2015·2015-01-21

    Medtronic Spinal Surgical Instrument Recall Due to Component Sizing Issue

    Medtronic is recalling 24 units of the POWEREASE Set Screw Breakoff Instrument because oversized retaining tabs may prevent proper mating with the set screw.

    Product
    POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
    Category
    Medical Device
    Distribution
    16 states
  • HighCPSC·15061·2015-01-21

    Mean Green Cleaner and Degreaser Recalled for Ammonia Mislabeling

    CR Brands is recalling Mean Green cleaner and degreaser products because they may contain ammonia despite labels stating otherwise, posing a chemical hazard.

    Product
    Mean Green® Super Strength Cleaner & Degreaser and Mean Green® Industrial Strength Cleaner & Degreaser
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0976-2015·2015-01-21

    Becton Dickinson Recalls Columbia Agar with 5% Sheep Blood Due to Listeria

    Becton Dickinson & Co. is recalling Columbia Agar with 5% Sheep Blood due to low-level Listeria monocytogenes contamination. The product is a non-sterile culture medium distributed worldwide.

    Product
    Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2015·2015-01-21

    Becton Dickinson Recalls CDC Anaerobe Agar Due to Listeria Contamination

    Becton Dickinson is recalling CDC Anaerobe 5% Sheep Blood Agar due to low-level Listeria monocytogenes contamination. The affected non-sterile media were distributed worldwide.

    Product
    CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0960-2015·2015-01-21

    Siemens Symbia CT Systems Recalled for Internal Component Damage

    Siemens Medical Solutions is recalling 295 Symbia T and T2 CT systems because a component may come loose and damage the equipment.

    Product
    Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2015·2015-01-21

    Biomet Timberline Anchored Lateral Variable Retractable Sleeves Recalled for Undersized Diameter

    Biomet Spine is recalling 12 units of Timberline Anchored Lateral Variable Retractable Sleeves because the inner diameter is undersized, causing interference fit issues.

    Product
    Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized…
    Category
    Medical Device
    Distribution
    6 states
  • HighNHTSA·15V017000·2015-01-20

    Jayco Eagle Fifth Wheel Trailers Recalled for Incorrect Tire Labeling

    Jayco is recalling 2015 Eagle 30.5 BHLT fifth wheel trailers because the tire labels list incorrect tire sizes. Owners should contact Jayco to receive corrected labels to prevent potential tire failure.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V019000·2015-01-20

    Volkswagen Recalls Audi and VW Models for Fuel Leak Fire Risk

    Volkswagen is recalling 26,008 Audi and Volkswagen vehicles because a fuel leak in the injection system could cause a fire.

    Product
    AUDI — AUDI, VOLKSWAGEN A7, A6, TOUAREG HYBRID, S4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V018000·2015-01-20

    Frontline Mobile Medical Units Recalled for Wheelchair Lift Defect

    Frontline Communications is recalling 2007-2011 Mobile Medical Units because wheelchair lift platform side plates may crack, posing an injury risk.

    Product
    FRONTLINE COMMUNICATIONS — FRONTLINE COMMUNICATIONS MOBILE MEDICAL UNIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15E001000·2015-01-20

    Tucker Rocky Recalls Speed and Strength SS500DVD Motorcycle Helmets

    Tucker Rocky is recalling specific Speed and Strength SS500DVD motorcycle helmets because they fail to meet federal safety standards, increasing the risk of serious injury in a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Remote Controls Due to Unintended Movement

    Trumpf Medical Systems is recalling JUPITER remote controls for operating tables because damaged units may cause unintended movement during surgery.

    Product
    IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient…
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0920-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Cable Remote Controls

    Trumpf Medical Systems is recalling JUPITER cable remote controls due to reports of unintended movement during surgical cases.

    Product
    Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0918-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER U Cable Remote Controls

    Trumpf Medical Systems is recalling 137 JUPITER U cable remote controls due to reports of unintended movement during surgical cases.

    Product
    Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0909-2015·2015-01-14

    Ebi Recalls Cypher MIS Screw System Due to Inoperative Screw Heads

    Ebi, LLC is recalling the Cypher MIS Screw System because screw heads may splay or fracture, rendering the device inoperative.

    Product
    Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0929-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Remote Controls for Unintended Movement

    Trumpf Medical Systems is recalling JUPITER remote controls due to reports of unintended movement during surgical cases caused by damaged units.

    Product
    IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0914-2015·2015-01-14

    Siemens e.cam Systems Recalled for Potential Patient Finger Injury

    Siemens Medical Solutions is recalling 4,462 e.cam emission computed tomography systems due to a potential risk of patient finger injury.

    Product
    e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2015·2015-01-14

    KCI CelluTome Epidermal Harvesting System Harvester Blades May Drift During Shipping

    KCI USA is recalling CelluTome Epidermal Harvesting System Harvesters because blades may drift and protrude from the top plate during shipping.

    Product
    CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2015·2015-01-14

    Centurion Chest Tube Tray Recalled Due to Human Hair Contamination

    Centurion Medical Products is recalling 42 Chest Tube Tray kits because a single unit was found to contain human hair embedded in the stopper.

    Product
    Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide