Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 8068 1/4” WITH BRIDGE Material: 701066883 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 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/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4” ECC PACK Material: 701067837 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 3501 LVAD/ 3/8” Material: 701068008 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 3502 LVAD 1/4” Material: 701068168 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 8207 1/4” ECC PACK Material: 701068395 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4” Material: 709000011 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 28906 1/4” with Bridge Ancillary P Material: 709000072 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 25501 3/8” Better Bladder Pack Material: 709000370 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 31603 CHKD 3/8” ECC Material: 709000516 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet Getinge-BEQ-TOP 31604 CHKD 1/4” ECC Material: 709000518 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of… Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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