Morrisville, NC, United States
TELEFLEX LLC recalls
9 recalls recorded since 2018, most recently on 7 May 2026. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)8
Terminated or completed1
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 7 May 2026
- Reason
- Due to out-of-specification, or potential out-of-specification, levels of endotoxins
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Panama.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2639-2026
- Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 20
Ongoing Class I Medical devices
- Recall started
- 25 May 2023
- Reason
- Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- Distribution
- US Nationwide distribution including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1834-2023, Z-1875-2023, Z-1937-2023, Z-1889-2023, Z-1905-2023, Z-1922-2023, Z-1892-2023, Z-1933-2023, Z-1896-2023, Z-1959-2023, Z-1869-2023, Z-1930-2023 and 111 more
- Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
- Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
- Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055
- Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
- Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055
- Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055
- Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
- Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065
- and 115 more product lines
Ongoing Class II Medical devices
- Recall started
- 25 May 2023
- Reason
- There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- Distribution
- Nationwide and Australia, Canada, S. Korea, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2096-2023, Z-2095-2023, Z-2097-2023
- Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
- Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
- Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
Ongoing Class II Medical devices
- Recall started
- 28 April 2023
- Reason
- Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1663-2023
- Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
Ongoing Class II Medical devices
- Recall started
- 12 April 2023
- Reason
- The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1611-2023
- 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 de
Ongoing Class II Medical devices
- Recall started
- 8 December 2022
- Reason
- Potential for pilot balloon non-inflation or cuff non-deflation.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WA, WI, WV and PR. The countries of Albania, Armenia, Austria, Azerbaijan, Bahamas, Barbados, Belg
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1011-2023, Z-1010-2023, Z-1012-2023
- 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 Sa
- Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
- 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 Sup
Terminated Class II Medical devices
- Recall started
- 28 September 2022
- Terminated
- 24 July 2026
- Reason
- Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
- Distribution
- Domestic distribution to IL, MS, PA, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0772-2023
- Pilling Wecksorb Cylindrical Sponges
Ongoing Class II Medical devices
- Recall started
- 20 September 2022
- Reason
- Product may not be sterile
- Distribution
- TN, CA, NC, TX, FL, OH, MO, IL, OR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0227-2023
- Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Ongoing Class I Medical devices
- Recall started
- 29 August 2022
- Reason
- Incidents of device splitting or detaching during use
- Distribution
- US nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0074-2023, Z-0075-2023, Z-0072-2023, Z-0077-2023, Z-0073-2023, Z-0076-2023
- Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
- 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,
- 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.
- Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
- Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.