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-T 4932 Mercy Adaptation Pk Pediatric Material:709000520 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 8013 ECC QUADROX iD Pack RF32 Material:701047962R01 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 5103 CPS Tubing Pack Material:701048690R01 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 17207 3/8” ECC Pack Material:701049346R01 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 22600 ECC QUADROX ID 3 Material:701049440R01 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 22600 ECC QUADROX iD 3/8 Material:701049440R02 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 21502 ECC Quadrox iD w/RF 3/8” Material:701050060R01 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 24100 Small Patient ECC Pack Material:701050175R02 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 24101 Adult ECC Pack Material:701050177R01 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 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01 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 15200 OR PACK HMO & RF Material:701050647R01 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 15704 Circulatory Circuit 3/8” Material:701050859R01 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 5502 ECC Pack Material:701051791R01 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 28601 NEONATE ECC QPiD Material: 701051935R01 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 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01 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 32200 ECC Pack Material: 701053319R01 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 20705 SMALL PATIENT 1/4 Material: 701053486R01 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 250011/4 1/4 Less than 20 kg up Material: 701053906R01 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 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 24202 ADULT ECC Material: 701054295R01 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 27700 Quadrox iD Pack Material: 701054389R02 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 32100 Adult Custom Pack Material:701054438R01 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 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01 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 13901 Rapid Response Universal Pk Material: 701054874R01 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 37200 E-Circuit Bioline Heparin Material: 701055388R01 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 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 5210 ECC Set - Respiratory Material: 701055604R01 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 38300 ADULT CPS QID Material:701055862R01 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 28901 MCV INFANT ECC Material:701056771R01 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 39700 ECC Pack Material:701062473R01 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 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 48400 OR PACK Material: 701064327R01 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 5211 ECC Large Children’s Hospital Material: 701064560R01 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 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01 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 41301 BUMC ECC PACK Material: -701065209R01 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 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 46700 ADULT ECC PACK Material:701065833R01 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 49101 Childrens Large ECC Pack Material: 701067069R01 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 39202 NICU ECC PACK Material: 701067313R01 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 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 40010 OPEN HEART PACK Material: -701067364R02 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 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: 701068008R01 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: 701068168R01 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:701068797R01 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 3/8” x 3/8” Adult Pack Material: 709000004R01 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 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02 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 Pk-Pdtrc 3/8 - Material: 709000078R01 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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