Teleflex Medical Inc

Complete recall history across all FDA and CPSC categories — 32 total recalls

Teleflex Medical Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (32)

FDA medical device enforcement actions by Teleflex Medical Inc

Date Product Reason Class
Apr 11, 2022 (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Fle... Reports received of torn corrugated breathing tubes. Class II
Apr 11, 2022 (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-... Reports received of torn corrugated breathing tubes. Class II
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I
Jan 11, 2022 Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containi... The firm received reports indicating PTD tip separation during use. Class I
Jan 11, 2022 Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (fin... The firm received reports indicating PTD tip separation during use. Class I
Jan 11, 2022 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I
Feb 18, 2021 RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visual... Teleflex is voluntarily recalling the products referenced above due to custom... Class II
Feb 12, 2021 PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter i... Teleflex is recalling this product due to a lack of assurance of sterility. Class II
Aug 7, 2020 Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter ... Potential sterility issue Class II
Jul 6, 2020 Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Produc... Breaking at the point of a welded joint Class II
Jul 6, 2020 Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Produc... Breaking at the point of a welded joint Class II
Jul 6, 2020 Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Produc... Breaking at the point of a welded joint Class II
Jul 6, 2020 Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product ... Breaking at the point of a welded joint Class II
Jul 6, 2020 Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Produ... Breaking at the point of a welded joint Class II
Jul 6, 2020 Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Produc... Breaking at the point of a welded joint Class II
Jul 6, 2020 Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Produc... Breaking at the point of a welded joint Class II
Jun 30, 2020 Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage:... Potential for sterile packaging to be compromised¿ Class II
Jun 30, 2020 Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product ... Potential for sterile packaging to be compromised¿ Class II
May 29, 2020 RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 10... Teleflex is initiating a voluntary recall for the above-mentioned products du... Class II
Jan 13, 2020 Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm,... There is a potential for the device packaging to become compromised; thus, th... Class II
Jan 13, 2020 Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 There is a potential for the device packaging to become compromised; thus, th... Class II
Jan 9, 2020 Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System The products are being recalled due to reports of breakage broke at the point... Class II
Jan 9, 2020 Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System The products are being recalled due to reports of breakage broke at the point... Class II
Dec 13, 2019 HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperatu... There is the potential for water to flood the column and enter the circuit un... Class I
Dec 13, 2019 HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, RE... There is the potential for water to flood the column and enter the circuit un... Class I
Dec 13, 2019 HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier... There is the potential for water to flood the column and enter the circuit un... Class I
Dec 13, 2019 HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit There is the potential for water to flood the column and enter the circuit un... Class I
Oct 11, 2019 Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex M... Teleflex received the attached Medical Device Recall Notice from Pajunk Medic... Class II
Oct 11, 2019 Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex M... Teleflex received the attached Medical Device Recall Notice from Pajunk Medic... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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