Browse Device Recalls
41 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 41 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 41 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 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 |
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ I... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is util... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aort... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
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.