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Teleflex Medical

221 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11 recall (Z-2311-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 recall (Z-2312-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF recall (Z-2313-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, recall (Z-2314-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF recall (Z-2315-2019)Teleflex Medical2019-09-09
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10 recall (Z-2316-2019)Teleflex Medical2019-09-09
Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management recall (Z-2317-2019)Teleflex Medical2019-09-09
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-1 recall (Z-2318-2019)Teleflex Medical2019-09-09
Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and Conch recall (Z-1912-2019)Teleflex Medical2019-07-15
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway manageme recall (Z-1759-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product C recall (Z-1760-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Co recall (Z-1761-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-2211 recall (Z-1762-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product recall (Z-1763-2019)Teleflex Medical2019-06-19
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-103 recall (Z-1764-2019)Teleflex Medical2019-06-19
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway man recall (Z-1765-2019)Teleflex Medical2019-06-19
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V recall (Z-1766-2019)Teleflex Medical2019-06-19
Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation. recall (Z-0705-2018)Teleflex Medical2018-02-23
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 3529 recall (Z-0039-2018)Teleflex Medical2017-10-16
LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MA recall (Z-3212-2017)Teleflex Medical2017-08-25
Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. recall (Z-1829-2017)Teleflex Medical2017-04-04
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube recall (Z-1177-2017)Teleflex Medical2017-02-09
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical recall (Z-0381-2017)Teleflex Medical2016-11-09
FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for th recall (Z-0382-2017)Teleflex Medical2016-11-09
FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anes recall (Z-0383-2017)Teleflex Medical2016-11-09
LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products ar recall (Z-0384-2017)Teleflex Medical2016-11-09
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These pr recall (Z-0385-2017)Teleflex Medical2016-11-09
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical ane recall (Z-0386-2017)Teleflex Medical2016-11-09
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe a recall (Z-0898-2017)Teleflex Medical2016-11-09
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularl recall (Z-0044-2017)Teleflex Medical2016-10-18
Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured recall (Z-0058-2017)Teleflex Medical2016-10-07
Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured recall (Z-0059-2017)Teleflex Medical2016-10-07
WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Cl recall (Z-2759-2016)Teleflex Medical2016-09-08
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 recall (Z-2683-2016)Teleflex Medical2016-08-29
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture c recall (Z-2374-2016)Teleflex Medical2016-08-09
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only recall (Z-1938-2016)Teleflex Medical2016-06-09
Pilling Modular Verres Body/Obturator, Product Code 140880 recall (Z-1178-2016)Teleflex Medical2016-03-16
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, recall (Z-0886-2016)Teleflex Medical2016-02-25
Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heate recall (Z-0419-2016)Teleflex Medical2015-12-15
Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex recall (Z-0245-2016)Teleflex Medical2015-11-06
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical. recall (Z-0246-2016)Teleflex Medical2015-11-06
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr. recall (Z-2367-2015)Teleflex Medical2015-08-20
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr recall (Z-2368-2015)Teleflex Medical2015-08-20
HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liqu recall (Z-2369-2015)Teleflex Medical2015-08-20
HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used recall (Z-2370-2015)Teleflex Medical2015-08-20
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver S recall (Z-1809-2015)Teleflex Medical2015-06-24
Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only. recall (Z-1558-2015)Teleflex Medical2015-04-30
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Onl recall (Z-1404-2015)Teleflex Medical2015-04-08
Hudson RCI Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 04 recall (Z-1095-2015)Teleflex Medical2015-02-12
AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an acce recall (Z-1096-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessor recall (Z-1097-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an acc recall (Z-1098-2015)Teleflex Medical2015-02-12
AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an acces recall (Z-1099-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an ac recall (Z-1100-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an recall (Z-1101-2015)Teleflex Medical2015-02-12
AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory whic recall (Z-1102-2015)Teleflex Medical2015-02-12
AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory recall (Z-1103-2015)Teleflex Medical2015-02-12
AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an acce recall (Z-1104-2015)Teleflex Medical2015-02-12
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an acc recall (Z-1105-2015)Teleflex Medical2015-02-12
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an acc recall (Z-1106-2015)Teleflex Medical2015-02-12
ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows recall (Z-1107-2015)Teleflex Medical2015-02-12
AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an acc recall (Z-1108-2015)Teleflex Medical2015-02-12
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an acc recall (Z-1109-2015)Teleflex Medical2015-02-12
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Tel recall (Z-1078-2015)Teleflex Medical2015-02-10
LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: recall (Z-1085-2015)Teleflex Medical2015-02-10
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Mo recall (Z-1051-2015)Teleflex Medical2015-02-06
WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended recall (Z-0826-2015)Teleflex Medical2014-12-17
Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Produc recall (Z-0504-2015)Teleflex Medical2014-12-12
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML recall (Z-0505-2015)Teleflex Medical2014-12-12
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Pa recall (Z-0799-2015)Teleflex Medical2014-12-12
Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product U recall (Z-2714-2014)Teleflex Medical2014-09-30
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These cathet recall (Z-2661-2014)Teleflex Medical2014-09-18
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only recall (Z-2154-2014)Teleflex Medical2014-08-06
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, R recall (Z-2130-2014)Teleflex Medical2014-07-29
Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device recall (Z-2119-2014)Teleflex Medical2014-07-26
Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifi recall (Z-2107-2014)Teleflex Medical2014-07-23
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, recall (Z-2108-2014)Teleflex Medical2014-07-23
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas hu recall (Z-2003-2014)Teleflex Medical2014-07-07
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas hu recall (Z-2004-2014)Teleflex Medical2014-07-07
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier recall (Z-2005-2014)Teleflex Medical2014-07-07
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adapto recall (Z-2006-2014)Teleflex Medical2014-07-07
Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier a recall (Z-2007-2014)Teleflex Medical2014-07-07
Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifie recall (Z-2008-2014)Teleflex Medical2014-07-07
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier recall (Z-2009-2014)Teleflex Medical2014-07-07
Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. recall (Z-2010-2014)Teleflex Medical2014-07-07
Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier ada recall (Z-2011-2014)Teleflex Medical2014-07-07
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor recall (Z-2012-2014)Teleflex Medical2014-07-07
Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier recall (Z-2013-2014)Teleflex Medical2014-07-07
Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier recall (Z-2014-2014)Teleflex Medical2014-07-07
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor. recall (Z-2015-2014)Teleflex Medical2014-07-07
Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor. recall (Z-2016-2014)Teleflex Medical2014-07-07
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier ad recall (Z-2017-2014)Teleflex Medical2014-07-07
RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy- recall (Z-1851-2014)Teleflex Medical2014-06-23
Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction recall (Z-1786-2014)Teleflex Medical2014-06-12
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Rese recall (Z-1732-2014)Teleflex Medical2014-06-09
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated f recall (Z-1555-2014)Teleflex Medical2014-05-07
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distribu recall (Z-1556-2014)Teleflex Medical2014-05-07
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed recall (Z-1557-2014)Teleflex Medical2014-05-07
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbab recall (Z-1558-2014)Teleflex Medical2014-05-07
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC recall (Z-1559-2014)Teleflex Medical2014-05-07
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Every clearance here is in the API, with alerts when new ones post.