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.

34951–34975 of 50502

  • HighFDA (Devices)·Z-2592-2016·2016-08-24

    Avid Medical Recalls Unlabeled Latex-Containing Telfa Dressing Kits

    Avid Medical is recalling 200 custom procedure trays that included latex-containing Telfa dressings without latex warnings. The products were distributed to Virginia and Massachusetts.

    Product
    MAMMOGRAPHY
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·16V619000·2016-08-24

    Audi A8 Recall: Coolant Valve Leak May Cause Engine Stall

    Volkswagen Group of America is recalling 2010-2013 Audi A8 vehicles because a coolant valve may leak, causing the engine to stall and increasing crash risk.

    Product
    AUDI — AUDI A8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2016·2016-08-24

    Synthes Titanium Single Vector Distractor Body Recalled for Fastener Separation

    Synthes (USA) Products LLC is voluntarily recalling Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2583-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

    Synthes (USA) Products LLC is voluntarily recalling 413 Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2016·2016-08-24

    Ab Sciex Mass Spectrometer Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for Triple Quad 4500MD systems because it may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2571-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Wire J-Hook Electrode Due to Sterility Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes due to a potential package compromise that could breach the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2016·2016-08-24

    Nidek Optical Biometer AL-Scan Recalled for Inaccurate Axial Length Measurements

    Nidek Inc. is recalling 17 Optical Biometer AL-Scan devices because they measured axial lengths as much shorter than actual values.

    Product
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16249·2016-08-24

    Safety 1st Step and Go Travel Systems Recalled for Fall Hazard

    Dorel Juvenile is recalling Safety 1st Step and Go Travel Systems because the stroller tray can disengage, posing a fall hazard to infants.

    Product
    Safety 1st Step and Go Travel Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2578-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Cylindrical Tip Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.

    Product
    Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2016·2016-08-24

    Synthes Titanium Single Vector Distractor Recalled for Fastener Separation Risk

    Synthes is recalling Titanium Single Vector Distractor Proximal Foot/Left devices because a fastener may separate prematurely from the plate.

    Product
    TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1923-2016·2016-08-24

    Coconut milk recalled for thermal under-processing

    Procesadora de Frutos y Vegetales del Caribe is voluntarily recalling specific lots of 13.5 oz canned coconut milk because the product was thermally under-processed.

    Product
    Coconut milk , 13.5 fld oz, can, 214x406 3 pieces steel tins ,24 tins per case. Refrigerate after opening.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2542-2016·2016-08-24

    Toshiba Recalls Xario Ultrasound Systems Due to Overheating Software Error

    Toshiba American Medical Systems is recalling 93 Xario 100 and 200 Diagnostic Ultrasound Systems because a software error may cause the devices to become hot.

    Product
    Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2585-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Proximal Foot Plates

    Synthes is voluntarily recalling Titanium Single Vector Distractor Proximal Foot Plates because the fastener may separate prematurely from the plate.

    Product
    TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2540-2016·2016-08-24

    TYRX Absorbable Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes

    TYRX Inc. is recalling 2,993 units of the TRYX Absorbable Antibacterial Envelope because key manufacturing processes were not adequately validated.

    Product
    TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2016·2016-08-24

    Stanmore METS SMILES Total Knee Replacement Recall for Fit Issues

    Stanmore Implants Worldwide Ltd. is recalling 3 units of METS SMILES Total Knee Replacements because the femoral plateau plates may not fit the intended mating component.

    Product
    METS SMILES Total Knee Replacement
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2548-2016·2016-08-24

    Cepheid Recalls Xpert MRSA Diagnostic Kits Due to Performance Issues

    Cepheid is recalling specific lots of Xpert MRSA diagnostic kits because internal investigations found potential performance issues at lower positive sample concentrations.

    Product
    Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal…
    Category
    Medical Device
    Distribution
    24 states
  • HighNHTSA·16V618000·2016-08-24

    Ford Recalls 2015-2016 Transit Vehicles Due to Fuel System Clog Risk

    Ford is recalling 2015-2016 Transit vehicles with 3.2L diesel engines because metallic debris may clog the fuel system, potentially causing the engine to stall and increasing crash risk.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2526-2016·2016-08-24

    Ab Sciex API 3200MD Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for API 3200MD systems due to potential incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V616000·2016-08-24

    Eldorado Aero Elite Recall for Side Lamp Visibility Defect

    Eldorado is recalling 2011-2016 Aero Elite vehicles because intermediate side lamps may not stay illuminated, reducing visibility and increasing crash risk.

    Product
    ELDORADO — ELDORADO AERO ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing, Inc. is recalling 33 Bone Level Implants due to misalignment with the Loxim transfer piece markings, which may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
    Category
    Medical Device
    Distribution
    Distributed nationwide