TELEFLEX MEDICAL INC

FDA Regulatory Profile

Summary

Total Recalls
236 (50 Class I)
510(k) Clearances
39
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1127-2022Class II(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, PApril 11, 2022
Z-1126-2022Class II(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, ProducApril 11, 2022
Z-0625-2022Class IArrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing cJanuary 11, 2022
Z-0628-2022Class I5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containingJanuary 11, 2022
Z-0629-2022Class IArrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) TheJanuary 11, 2022
Z-0626-2022Class IArrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing January 11, 2022
Z-0624-2022Class IArrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containinJanuary 11, 2022
Z-0623-2022Class IArrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containingJanuary 11, 2022
Z-0627-2022Class IArrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-4550January 11, 2022
Z-1294-2021Class IIRUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeaFebruary 18, 2021
Z-1298-2021Class IIPLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogeFebruary 12, 2021
Z-2922-2020Class IIPleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be usedAugust 7, 2020
Z-2726-2020Class IIRusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngosJuly 6, 2020
Z-2728-2020Class IIRusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngosJuly 6, 2020
Z-2729-2020Class IIRusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngosJuly 6, 2020
Z-2731-2020Class IIRusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngosJuly 6, 2020
Z-2732-2020Class IIRusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscoJuly 6, 2020
Z-2730-2020Class IIRusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngosJuly 6, 2020
Z-2727-2020Class IIRusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoJuly 6, 2020
Z-2749-2020Class IIPleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: June 30, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsJuly 3, 2025
K242495LMA Fastrach ETT SUApril 29, 2025
K243553QuikClot Control+ Hemostatic DeviceMarch 18, 2025
K241784Arrow® Nitinol WireSeptember 18, 2024
K233713Pilling Tracheostomy TubesMarch 22, 2024
K232970Hem-o-lok® Ligating ClipsJanuary 12, 2024
K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock AdaptAugust 30, 2023
K231924EZ-IO Intraosseous Vascular Access SystemJuly 25, 2023
K230480Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)April 28, 2023
K222279Rusch Intermittent Urethral CathetersAugust 29, 2022
K202492EZ-IO Intraosseous Vascular Access SystemMarch 22, 2021
K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchMarch 30, 2020
K193530Deklene MAXXMarch 19, 2020
K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)August 21, 2019
K180253Sheridan Endobronchial TubesNovember 2, 2018
K173321StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) PeripheralApril 25, 2018
K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous DeviceApril 17, 2018
K173596Rusch Intermittent Urethral CathetersJanuary 29, 2018
K161758Weck Auto Endo10 Automatic Endoscopic Clip ApplierSeptember 7, 2016
K153470MADgic Laryngo-Tracheal Mucosal Atomization DeviceAugust 19, 2016