Browse Device Recalls

264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 264 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 264 FDA device recalls.

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DateProductReasonClassFirm
Sep 20, 2022 Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Ki... Product may not be sterile Class II TELEFLEX LLC
Apr 11, 2022 (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Fle... Reports received of torn corrugated breathing tubes. Class II TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
Jul 16, 2021 RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numb... The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... Class II Teleflex Medical Europe Ltd
Jul 16, 2021 RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, RE... The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... Class II Teleflex Medical Europe Ltd
Jul 16, 2021 RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff... The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... Class II Teleflex Medical Europe Ltd
Jul 16, 2021 RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numb... The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... Class II Teleflex Medical Europe Ltd
Feb 18, 2021 RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visual... Teleflex is voluntarily recalling the products referenced above due to customers reporting that t... Class II TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
Aug 7, 2020 Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter ... Potential sterility issue Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Produc... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Produc... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Produc... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product ... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Produ... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Produc... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Produc... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
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 TELEFLEX MEDICAL INC
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 due to reports indicat... Class II TELEFLEX MEDICAL INC
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, the sterility of the d... Class II TELEFLEX MEDICAL INC
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, the sterility of the d... Class II TELEFLEX MEDICAL INC
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 of a welded joint e... Class II TELEFLEX MEDICAL INC
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 of a welded joint e... Class II TELEFLEX MEDICAL INC
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 under circumstances wh... Class I TELEFLEX MEDICAL INC
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 under circumstances wh... Class I TELEFLEX MEDICAL INC
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 under circumstances wh... Class I TELEFLEX MEDICAL INC
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 under circumstances wh... Class I TELEFLEX MEDICAL INC
Oct 30, 2019 HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usa... The tracheal and brochial swivel connectors are incorrectly labeled. Class II Teleflex Medical
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 Medical. Teleflex Medical... Class II TELEFLEX MEDICAL INC
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 Medical. Teleflex Medical... Class II TELEFLEX MEDICAL INC
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 4, 2019 WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic E... Certain clip appliers have an increase in misloading and/or jamming related complaints that may b... Class II Teleflex Medical
Oct 4, 2019 WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543... Certain clip appliers have an increase in misloading and/or jamming related complaints that may b... Class II Teleflex Medical
Jul 30, 2019 Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/ai... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c)... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) ... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-104... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 m... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical
Jul 30, 2019 Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) ... Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... Class I Teleflex Medical

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.