Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the… This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific… Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedSep 9, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD Alaris System Infusion pump component defect may result in interruption of patient monitoring Class IIFDA’s classSep 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedSep 9, 2020ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas, Washington and Wisconsin named
- Medical device recall Parvovirus B19 IgG EIA kit Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value Class IIFDA’s classSep 9, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedSep 9, 2020ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Virginia and Wisconsin
- Medical device recall LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science… The defect relates to firmware version lower than V02.13.00. Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01,… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01-… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 -… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 -… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01… Potential Endotoxin Contamination Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cios Alpha (VA20) Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat:… Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920 Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNevadathe one state its words name PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNevada
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile) Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿ Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total… Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL… Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass 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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