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.

29801–29825 of 50499

  • HighFDA (Devices)·Z-0643-2018·2018-02-28

    Pentax Video Duodenoscope Recalled to Mitigate Infection Risk

    Pentax of America Inc is recalling 559 Video Duodenoscopes to replace specific components and update inspection protocols to mitigate the potential risk of infection.

    Product
    Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2018·2018-02-28

    Ethicon Recalls Disposable Curved Circular Staplers Due to Malformed Staple Risk

    Ethicon Endo-Surgery Inc is recalling specific lots of disposable curved circular staplers because they may create staples that do not meet height specifications, resulting in malformed staples.

    Product
    Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0687-2018·2018-02-28

    Cosman Medical Recalls Nitinol TC Reusable Electrodes Due to Epoxy Damage

    Cosman Medical is recalling Nitinol TC Reusable Electrodes because epoxy damage after reprocessing can prevent the removal of blood and tissue residuals.

    Product
    Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide

    Arrow International is recalling 5,926 Central Venous Catheterization Kits with Blue FlexTip Catheters because they may contain the incorrect Springwire Guide.

    Product
    Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V135000·2018-02-27

    ACG Recalls 2016-2017 Moke Vehicles for Non-Laminated Windshields

    American Custom Golf Cars is recalling 2016-2017 Moke vehicles because some have non-laminated windshields that fail federal safety standards, increasing injury risk in crashes.

    Product
    ACG — ACG MOKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18725·2018-02-22

    Yamaha Recalls Golf Cars and PTVs Due to Brake Cable Failure Hazard

    Yamaha is recalling about 161,000 golf cars and personal transportation vehicles because brake cables can fail, posing a crash hazard. No injuries have been reported.

    Product
    Yamaha Golf Cars and Personal Transportation Vehicles (PTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V131000·2018-02-22

    2017 Jeep Renegade Recall for Cracked Oil Pump Housing

    Chrysler is recalling 2017 Jeep Renegade vehicles with 2.4L engines due to a cracked oil pump housing that can cause engine stalling and increase crash risk.

    Product
    JEEP — JEEP RENEGADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18106·2018-02-22

    Monster Moto Recalls 212cc Mini Bikes Due to Fuel Leak Fire Hazard

    Monster Moto is recalling about 1,800 Classic 212cc mini bikes because the fuel tank venting system can leak gasoline, posing a fire hazard.

    Product
    Monster Moto Classic 212cc mini bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2018·2018-02-21

    Graham Medical SnugFit Mattress Cover Recalled for Potential Tearing

    Little Rapids Corporation is recalling Graham Medical SnugFit Expandable Mattress Covers because material defects may cause the cover to tear during lifting, posing a fall risk.

    Product
    EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0565-2018·2018-02-21

    C.R. Bard Recalls CritiCore Monitors Due to Measurement and Alarm Failures

    C.R. Bard is recalling 343 CritiCore monitors because they may experience urine output and temperature measurement fluctuations and alarm errors.

    Product
    BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0563-2018·2018-02-21

    Kalila Medical Recalls Vado Steerable Sheaths Due to Torn Liner

    Kalila Medical is recalling 99 Vado Steerable Sheaths because internal testing detected torn liner material at the proximal end, potentially caused by manufacturing damage.

    Product
    Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0577-2018·2018-02-21

    Smiths Medical Recalls Single Custom Tracheostomy Device for Missing Sterilization

    Smiths Medical is recalling one custom tracheostomy device that was shipped without required sterilization. The device was distributed to a customer in Germany.

    Product
    Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0564-2018·2018-02-21

    Kalila Medical Recalls Vado Bi-Directional Steerable Sheaths Due to Torn Liner

    Kalila Medical is recalling 261 Vado Bi-Directional Steerable Sheaths because torn liner material was detected during internal testing, potentially caused by manufacturing damage.

    Product
    Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0596-2018·2018-02-21

    Zimmer Biomet Recalls Persona Partial Knee System Impactor Pads

    Zimmer Biomet is recalling 1,275 Persona Partial Knee System instruments because the impactor pad may fracture during use.

    Product
    Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2018·2018-02-21

    GE Carestation 600 Series Recalled for Possible Incomplete CO2 Absorber Seal

    GE Medical Systems is recalling Carestation 600 Series anesthesia machines due to a possible incomplete seal between the CO2 absorber and breathing circuit.

    Product
    Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-0592-2018·2018-02-21

    Cepheid Recalls Xpert CT/NG Tests Due to Temperature Drift Errors

    Cepheid is recalling specific batches of Xpert CT/NG tests due to reports of higher-than-expected temperature drift errors and an occasional probability of false negative results.

    Product
    Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0568-2018·2018-02-21

    B. Braun Recalls Perifix Anesthesia Trays Due to Foreign Matter

    B. Braun Medical is recalling 700 Perifix Single Dose Epidural Anesthesia Trays because they contain loose polypropylene foreign matter above release specifications.

    Product
    Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0348-2018·2018-02-21

    Sage Products Recalls Q.Care Oral Cleansing Kits Due to Cross-Contamination

    Sage Products is recalling 1,182 Q.Care Oral Cleansing & Suctioning System kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution. Manufactured by: Sage Products, LLC., 3909 Three Oaks Road, Cary, IL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2018·2018-02-21

    Zimmer Biomet Recalls G7 Dual Mobility Hip Liners Due to Labeling Error

    Zimmer Biomet is recalling 8 units of G7 Dual Mobility Liners because they are labeled as 44mm but may physically be 42mm liners.

    Product
    G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal…
    Category
    Medical Device
    Distribution
    Distributed nationwide