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 5, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall PALLAS M/MAXIMIS MIS Tapper 5.5mm Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS MIS Tapper 6.5mm Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Open Extension (Small) Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Open Extension (Large) Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Closed Extension Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Extension Block Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Extension Driver Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Extension Guide Bush Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Extension Sleeve Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Compass Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Anti Torque Device Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0 Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Rod Bender Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Rod Checker Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Rod Gauge Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS MIS Alignment Driver Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Rod Checker and T-Bar Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Rod Pusher Angled Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Torque Handle Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Ratchet T Handle Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS I Handle Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS MIS Anti Torque Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Head Holder Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Nut Inserter B Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS S Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS C Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Body Alignment Driver Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Driver Shaft Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Persuader Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Set Screw Starter Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Guide Wire Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Rod Pusher B Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking… Incorrect PEC values. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement Report20 statesnamed in where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereAlaska, Connecticut, Georgia, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia and Washington
- Medical device recall Olympus Scientific Solutions Americas Corporation ( OSSA ) Instruments may, under certain specific circumstances listed below, fail to stop when a test is initiated and no sample is present (proximity shut down fails… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Inspection Technologies Blade|line Industrial Cabinet X-ray system GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereAlabama, Michigan, Ohio, Pennsylvania and South Carolina
- Medical device recall Myelotec Video Guided Catheters Obstructed/blocked port from defective VGC Access Port Body component. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusOngoingWhereCalifornia, Florida, Kentucky, Minnesota and New Jersey
- Medical device recall Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small… There is a material mislabeling of the AFN End Cap. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereMaryland, New York and Pennsylvania
- Medical device recall ViaPeel PTFE Peelable Introducer 5FR Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Biosense Webster MobiCath Bi-Directional Guiding Sheath One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, LONG PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass 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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