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 5, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ORTHOFIX Catalogue Number As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Visual-ICE Cryoablation System, FPRCH6000 Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement Report22 statesnamed in where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, North Dakota, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Utah and Virginia
- Medical device recall Aequalis Ascend Flex Humeral Stem During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes Class IIFDA’s classNov 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Babi.Plus 12.5 cm H2O Pressure Relief Manifold Device vented gas below the stated pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedNov 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wyoming named
- Medical device recall Rosa Brain 3.0 The instrument holder may be sent on a trajectory that is not within the intended target. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE,… There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed… There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of… An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of… An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of… An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of… An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of… An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Autoject EI, REF AJ1310 There is a possible assembly error on Autoject EI, lot number V14. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 13, 2019ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Kentucky, Louisiana, Missouri, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina and Texas
- Medical device recall Petfine Auto Injector There is a possible assembly error on Autoject EI, lot number V14. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 13, 2019ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Kentucky, Louisiana, Missouri, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina and Texas
- Medical device recall Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon… One lot of “Low Level Output Cable - Interface to Philips Monitor” was received from the supplier with an incorrect cable in the packaging. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 13, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia and Texas
- Medical device recall VITROS chemistry Products Cl- Slides Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge. Class IIFDA’s classNov 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 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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