Browse Device Recalls
791 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 791 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 791 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 18, 2019 | Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 70105... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Ma... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 70105... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 22701 Material: 701050790 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 9, 2019 | Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assaye... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 9, 2019 | Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assaye... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 3, 2019 | Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 4... | An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) Ig... | Class II | Bio-Rad Labs |
| Feb 28, 2019 | SmartSite Syringe Administration Set-Product Package Size 50, Catalog Numbe... | Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infu... | Class I | Becton Dickinson & Company |
| Feb 22, 2019 | xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitativ... | Reports have been received of lower MS2 MFI values when using the panel. | Class II | Luminex Molecular Diagnostics |
| Feb 19, 2019 | Foot Switches used with the following systems: 722001 Allura Xper FD 10 C ... | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitc... | Class II | Philips Medical Systems Nederlands |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Jan 28, 2019 | Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: ... | The product may not have met sterility requirements . Use of a non-sterile device on a patient m... | Class II | Applied Medical Resources Corp |
| Jan 14, 2019 | BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX S... | False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically... | Class II | Becton Dickinson & Co. |
| Jan 9, 2019 | Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Lab... | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | ConvaTec, Inc |
| Dec 26, 2018 | Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G... | On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplifica... | Class III | Luminex Corporation |
| Dec 21, 2018 | SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resona... | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... | Class II | Philips Medical Systems Nederlands |
| Dec 21, 2018 | Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper A... | The product was potentially being packaged without a taper adapter. | Class II | Zimmer Biomet, Inc. |
| Dec 21, 2018 | SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic... | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... | Class II | Philips Medical Systems Nederlands |
| Dec 12, 2018 | GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with... | Unintentional shifting of the tip insulation of the firm's electrosurgical probes. | Class II | Applied Medical Resources Corp |
| Nov 27, 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... | Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... | Class II | ICU Medical, Inc. |
| Nov 27, 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... | Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... | Class II | ICU Medical, Inc. |
| Nov 27, 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... | Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... | Class II | ICU Medical, Inc. |
| Nov 19, 2018 | Medex High Pressure Stopcock used to control the direction of IV fluid flow. ... | Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that m... | Class II | Smiths Medical ASD Inc. |
| Oct 17, 2018 | Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should ... | There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally rel... | Class II | Richard Wolf GmbH |
| Oct 16, 2018 | MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PUL... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
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.