Manufacturer

TELEFLEX MEDICAL INC

32 recalls in our database name TELEFLEX MEDICAL INC as the manufacturing or recalling firm.

What the numbers show

Total: 32
Critical: 2
Severe: 10
Most recent: 2022-06-01

Of the 32 recalls from TELEFLEX MEDICAL INC we have scored against our rubric, 2 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (31%) are Severe.

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.

1–25 of 32

HighFDA (Devices)·Z-1126-2022·2022-06-01
Gibeck Humid-Vent Breathing Filters Recalled for Torn Corrugated Tubes
Teleflex Medical is recalling Gibeck brand respiratory filters due to reports of torn corrugated breathing tubes. No injuries have been reported.
Product
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Prod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1127-2022·2022-06-01
Teleflex Breathing Tubes Recalled Due to Reports of Tearing
Teleflex Medical Inc is recalling four models of breathing tubes following reports of torn corrugated tubes. Approximately 290,809 units are affected worldwide.
Product
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0626-2022·2022-02-23
Arrow-Trerotola Percutaneous Thrombolytic Device Kits Recalled for Tip Separation
Teleflex is recalling Arrow-Trerotola Percutaneous Thrombolytic Device kits worldwide due to reports of tip separation during use, affecting approximately 1,874 units.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits me
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0628-2022·2022-02-23
Arrow-Trerotola Thrombolytic Catheter Kits Recalled for Tip Separation During Use
Teleflex Medical is recalling 5,530 Arrow-Trerotola PTD catheter kits due to reports of tip separation during use. The hazard could prevent the device from functioning properly to remove blood clots from dialysis access grafts.
Product
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0625-2022·2022-02-23
Arrow-Trerotola Dialysis Catheter Recalled for Tip Separation During Use
Arrow-Trerotola Over-The-Wire PTD catheters used in dialysis procedures are being recalled due to reports of tip separation during use. The FDA classified this as a Class I recall affecting 1,265 units worldwide.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of nati
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0627-2022·2022-02-23
Arrow-Trerotola Percutaneous Thrombolytic Device catheter tips may separate during use
The FDA is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters due to reports of tip separation during use. Approximately 3,668 units were distributed worldwide.
Product
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0624-2022·2022-02-23
Teleflex Arrow-Trerotola Percutaneous Thrombolytic Device PTD Kit recalled for tip separation
Teleflex recalls approximately 1,400 Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) kits due to reports of tip separation during use. The medical device is used for dialysis graft declotting and has been distributed worldwide.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0623-2022·2022-02-23
Arrow-Trerotola Thrombolytic Device Tip Separation During Use Recalled
Teleflex Medical is recalling Arrow-Trerotola PTD kits due to reports of tip separation during use. The affected device is used for declotting dialysis grafts and fistulae.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0629-2022·2022-02-23
Arrow-Trerotola Percutaneous Thrombolytic Device Set Tip Separation Recall
Teleflex Medical Inc. is recalling Arrow-Trerotola PTD catheter sets due to reported tip separation during use. The device is used for mechanical declotting of vascular access fistulae and grafts.
Product
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fist
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1298-2021·2021-03-31
Teleflex Recalls PLEUR-EVAC Thoracic Catheters Due to Sterility Concerns
Teleflex is recalling 520 PLEUR-EVAC Thoracic Catheters because the company cannot guarantee the devices are sterile.
Product
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in stra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1294-2021·2021-03-31
Teleflex Recalls Rusch Polaris Laryngoscopes Due to Handle Cracking
Teleflex is voluntarily recalling Rusch Polaris laryngoscopes because customers reported that the handles develop cracks or break at the hinge.
Product
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2922-2020·2020-09-09
Teleflex Pleur-evac Thoracic Catheters Recalled for Potential Sterility Issue
Teleflex Medical Inc is recalling Pleur-evac Thoracic Catheters due to a potential sterility issue. The recall affects 700 units distributed across 25 US states.
Product
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-2748-2020·2020-08-12
Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Risk
Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.
Product
Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and main
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2749-2020·2020-08-12
Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Compromise
Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.
Product
Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish an
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2729-2020·2020-08-05
Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage
Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 20,600 units distributed nationwide.
Product
Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2730-2020·2020-08-05
Teleflex Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage
Teleflex Medical Inc is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The devices are used for tracheal intubation.
Product
Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2732-2020·2020-08-05
Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage
Teleflex Medical Inc. is recalling 29,740 Rusch Greenlite laryngoscopes because the welded joint may break. The devices are used for tracheal intubation.
Product
Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2726-2020·2020-08-05
Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage
Teleflex Medical Inc. is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall affects 75,320 units distributed nationwide.
Product
Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2728-2020·2020-08-05
Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage
Teleflex Medical Inc. is recalling 7,401 Rusch Greenlite laryngoscopes because the welded joint may break during use.
Product
Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2731-2020·2020-08-05
Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage
Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joints may break. The devices are used for tracheal intubation.
Product
Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2727-2020·2020-08-05
Teleflex Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage
Teleflex Medical Inc is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 27,341 units distributed nationwide.
Product
Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2533-2020·2020-07-15
Teleflex Recalls RUSCH LASERTUBE Devices Due to Laser Guard Foil Separation
Teleflex is voluntarily recalling 6,014 RUSCH LASERTUBE devices because the laser guard foil may partially separate or detach at the edges when exposed to moisture.
Product
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage:
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2129-2020·2020-06-03
Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns
Teleflex Medical is recalling 4,227 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing their sterility.
Product
Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic l
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2130-2020·2020-06-03
Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns
Teleflex Medical is recalling 800 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing sterility.
Product
Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic l
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1269-2020·2020-02-26
Teleflex Recalls Pilling Aortic Punch Due to Packaging Compromise
Teleflex Medical Inc. is recalling 1,764 Pilling Aortic Punch devices because packaging defects may compromise sterility.
Product
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Category
Medical Device
Distribution
0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Teleflex Medical

Czech company

Country: Czech Republic

Source: Wikidata (Q121622528), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.