Browse Device Recalls
774 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 774 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 774 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 18, 2019 | Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831 | 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 Material:701054874 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757 | 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: -709000093R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 7090000... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:70900049... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T-22800 Material: 701049506 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518 | 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 Pack Wake For Material: 7010648... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK Material: 701068395 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 4901 Material: 701050839 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE Material: 701066883 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
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.