The Recall Desk

Manufacturer

TELEFLEX LLC

139 recalls in our database name TELEFLEX LLC as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

126–139 of 139

  • SevereFDA (Devices)·Z-1960-2023·2023-07-05

    Endotracheal Tubes Recalled Due to 15mm Connector Disconnection Reports

    TELEFLEX LLC is recalling 6,710 endotracheal tubes due to reports of 15mm connector disconnection. This Class I recall affects units distributed nationwide.

    Product
    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2023·2023-06-07

    Teleflex HORIZON Titanium ligating clips recalled for missing cartridge safety feature

    Teleflex LLC is recalling approximately 146,606 units of HORIZON Microclip Titanium Ligating Clips because a safety feature is missing from the clip cartridge. Without this step feature, clips may be positioned variably and applied inadequately to blood vessels during surgery.

    Product
    Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1611-2023·2023-05-24

    Teleflex D-Stat Flowable Hemostat Recalled for Expired Diluent Vial

    Teleflex is recalling D-Stat Flowable Hemostat units with expired diluent vials that cannot assure sterility. No illnesses or injuries have been reported.

    Product
    Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2023·2023-02-01

    Endotracheal tubes recalled for potential pilot balloon and cuff malfunction

    TELEFLEX LLC recalls 39,690 endotracheal tubes for potential pilot balloon non-inflation or cuff non-deflation. These critical airway devices may not function properly during patient intubation.

    Product
    Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2023·2023-02-01

    Teleflex Endotracheal Tubes Recalled for Potential Cuff and Balloon Dysfunction

    Teleflex is recalling approximately 497 endotracheal tubes worldwide due to potential failure of pilot balloon inflation or cuff deflation, which could interfere with airway management.

    Product
    Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Inse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2023·2023-02-01

    Endotracheal Tubes May Fail to Inflate Pilot Balloon or Deflate Cuff

    TELEFLEX LLC is recalling 2,270 units of Slick Set Endotracheal Tubes due to potential pilot balloon non-inflation or cuff non-deflation. The devices were distributed worldwide including the United States.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2023·2023-01-04

    Pilling Wecksorb Cylindrical Sponges recalled due to compromised sterility

    TELEFLEX LLC recalled 1,000 units of Pilling Wecksorb Cylindrical Sponges (Lot 22B0395) because certain lots were not irradiated to eliminate pyronema, potentially compromising sterility. No illnesses have been reported.

    Product
    Pilling Wecksorb Cylindrical Sponges
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0227-2023·2022-11-23

    Teleflex RUSCH Pocket Pac Urinary Catheter Kit Recalled for Sterility Concerns

    Teleflex Medical recalled approximately 7,200 RUSCH Pocket Pac i.c. urinary catheter kits due to potential sterility issues. Patients should contact their healthcare provider and discontinue use.

    Product
    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0077-2023·2022-10-26

    Teleflex Catheter Mount and Filter May Split or Detach During Use

    Catheter mounts with filters (REF 191667-000100) used to connect endotracheal tubes or masks to breathing circuits may split or detach during patient use. Teleflex is recalling affected units distributed nationwide.

    Product
    Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0072-2023·2022-10-26

    Iso-Gard Filter S Recalled for Device Splitting or Detachment During Use

    Teleflex is recalling Iso-Gard Filter S microbial filters (60,500 units) due to incidents of device splitting or detaching during use. The filters protect patients and equipment from bacterial and viral contamination in breathing systems.

    Product
    Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2023·2022-10-26

    Medical Gas Filter Devices Recalled Due to Splitting and Detachment Risk

    Teleflex is recalling Iso-Gard Filter S microbial medical gas filters that may split or detach during use. The recall affects 164 units distributed nationwide.

    Product
    Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0073-2023·2022-10-26

    Iso-Gard Filter S Medical Gas Filter Recall Due to Splitting or Detachment

    TELEFLEX LLC is recalling Iso-Gard Filter S microbial medical gas filters due to incidents where the device may split or detach during use. The FDA classified this as a Class I recall.

    Product
    Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0076-2023·2022-10-26

    Medical gas filter recalled due to splitting and detachment risk

    TELEFLEX LLC is recalling Iso-Gard Filter S medical gas filters due to incidents of device splitting or detaching during use. The affected filters may compromise patient safety.

    Product
    Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2023·2022-10-26

    Iso-Gard Filter S Medical Gas Filters Recalled Due to Device Splitting Risk

    TELEFLEX is recalling 355 units of Iso-Gard Filter S medical gas filters nationwide due to incidents of device splitting or detaching during use. The FDA classified this as a Class I recall.

    Product
    Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
    Category
    Medical Device
    Distribution
    Distributed nationwide