Teleflex Medical
FDA Regulatory Profile
Teleflex Medical has 236 FDA recalls (50 Class I), 7 inspections, 44 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1127-2022 · Class II · Apr 11, 2022
- Latest inspection
- Sep 20, 2017 · VAI
- Latest 510(k)
- Jul 9, 2026
Newer recall under related name Teleflex: May 7, 2026, Z-2639-2026.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 236 (50 Class I) | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 44 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 7 | Oct 25, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1127-2022 | Class II | (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel… | Apr 11, 2022 |
| Z-1126-2022 | Class II | (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC… | Apr 11, 2022 |
| Z-0629-2022 | Class I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The… | Jan 11, 2022 |
| Z-0626-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing… | Jan 11, 2022 |
| Z-0625-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing… | Jan 11, 2022 |
| Z-0623-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing… | Jan 11, 2022 |
| Z-0624-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC… | Jan 11, 2022 |
| Z-0628-2022 | Class I | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing… | Jan 11, 2022 |
| Z-0627-2022 | Class I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components… | Jan 11, 2022 |
| Z-1294-2021 | Class II | RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the… | Feb 18, 2021 |
| Z-1298-2021 | Class II | PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non… | Feb 12, 2021 |
| Z-2922-2020 | Class II | Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used… | Aug 7, 2020 |
| Z-2726-2020 | Class II | Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The… | Jul 6, 2020 |
| Z-2729-2020 | Class II | Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The… | Jul 6, 2020 |
| Z-2728-2020 | Class II | Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The… | Jul 6, 2020 |
| Z-2727-2020 | Class II | Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The… | Jul 6, 2020 |
| Z-2732-2020 | Class II | Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The… | Jul 6, 2020 |
| Z-2731-2020 | Class II | Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The… | Jul 6, 2020 |
| Z-2730-2020 | Class II | Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The… | Jul 6, 2020 |
| Z-2748-2020 | Class II | Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To… | Jun 30, 2020 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Sep 20, 2017 | Mansfield, MA | Devices | Voluntary Action Indicated (VAI) | 1221601 |
| Dec 15, 2014 | Kernen, Germany | Devices | No Action Indicated (NAI) | 3005411785 |
| Jan 11, 2013 | Durham, NC | Devices | No Action Indicated (NAI) | 3004943382 |
| Oct 24, 2012 | Mansfield, MA | Devices | No Action Indicated (NAI) | 1221601 |
| Jun 1, 2010 | Fort Worth, TX | Devices | No Action Indicated (NAI) | 3005428244 |
| Mar 23, 2010 | Durham, NC | Devices | Voluntary Action Indicated (VAI) | 3004943382 |
| Aug 27, 2009 | Mansfield, MA | Devices | Voluntary Action Indicated (VAI) | 1221601 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Jul 9, 2026 |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape | May 6, 2026 |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating Clips | Jul 3, 2025 |
| K242495 | LMA Fastrach ETT SU | Apr 29, 2025 |
| K243553 | QuikClot Control+ Hemostatic Device | Mar 18, 2025 |
| K241784 | Arrow® Nitinol Wire | Sep 18, 2024 |
| K233713 | Pilling Tracheostomy Tubes | Mar 22, 2024 |
| K232970 | Hem-o-lok® Ligating Clips | Jan 12, 2024 |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock… | Aug 30, 2023 |
| K231924 | EZ-IO Intraosseous Vascular Access System | Jul 25, 2023 |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Apr 28, 2023 |
| K222279 | Rusch Intermittent Urethral Catheters | Aug 29, 2022 |
| K202492 | EZ-IO Intraosseous Vascular Access System | Mar 22, 2021 |
| K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | Mar 30, 2020 |
| K193530 | Deklene MAXX | Mar 19, 2020 |
| K190026 | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) | Aug 21, 2019 |
| K191268 | Force Fiber Suture | Jun 11, 2019 |
| K180253 | Sheridan Endobronchial Tubes | Nov 2, 2018 |
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape… | Oct 10, 2018 |
| K173321 | StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5) Peripheral… | Apr 25, 2018 |