Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Non-Sterile Double DIN to DIN “Y” Connector, Product Usage: Extension for connecting hemodialysis blood… A customer relayed a complaint of a leaking dialysis tubing connector. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall JResultNet drivers using ASTM coding language Software issue resulting in the results of one patient potentially being associated with another. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import… The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Plum 360 Infusion Pump, Software Version 15.02 Depleted Battery alarm shows instead of Replace Battery. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hand Foot II, UVB-138 The wiring may allow the lamps to turn on with the key switch rather than the timer. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereIowa, Illinois, Michigan, New York, Pennsylvania and Wisconsin
- Medical device recall Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to… After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereCalifornia, New Jersey and Virginia
- Medical device recall Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human… After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereCalifornia, New Jersey and Virginia
- Medical device recall Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60… The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for… Software changes now available to address several issues Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used… Software changes now available to address several issues Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 8500M Handheld Pulse Oximeter Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereMichigan, North Carolina, Ohio and Virginia
- Medical device recall Altius M-INI OCT Posterior Spinal Fixation System Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use… The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 5, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall SynchroMed II implantable drug infusion pump Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereIllinois
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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