Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue) The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - Acorn Bur, Long, For Use With TPS Universal Drill, Long “AM” Attachment Head: 7.5mm Dia The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Barron Radial Vacuum Trephine The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - Cannulated Drill Bit for Mini TightRope Ref The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - Calf Garment Standard Ref The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series… Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Maryland, Minnesota, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Texas named
- Medical device recall Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128… Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished… There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For… There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative,… There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro… There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ORTHO¿ Assay Software (OAS) Server There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series… Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Massachusetts, Minnesota, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a… It has come to Penlon Ltd’s attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Illinois, Kentucky, Minnesota, North Dakota, New Jersey, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy. Due to lack of sterilization. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Puerto Rico, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy. Due to lack of sterilization. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Puerto Rico, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy. Due to lack of sterilization. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Puerto Rico, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall ***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may… The RPM of the Motor Handpiece may be less than 80,000 RPM. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Kentucky, Maine, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM… The RPM of the Motor Handpiece may be less than 80,000 RPM. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Kentucky, Maine, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax… The RPM of the Motor Handpiece may be less than 80,000 RPM. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Kentucky, Maine, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Custom Procedural Trays: Merit’s Custom Angio Kits A custom procedural tray is a combination of legally Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the… DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD MAX Instrument Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled. Class IIIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW… The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation… The S-LIFT Instrument Case contained a bracket with peeling nylon coating. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, District of Columbia, Florida, Illinois, Kansas, Minnesota, Missouri, Ohio, Oklahoma, Tennessee, Texas and Virginia named
- Medical device recall S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further… The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Massachusetts, Missouri, New Jersey, Oklahoma and Texas named
- Medical device recall InSpan Inserter, Right Assembly Potential for set screw to be come deformed. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, District of Columbia, Florida, Illinois, Kansas, Minnesota, Missouri, Ohio, Oklahoma, Puerto Rico, Tennessee, Texas and Virginia named
- Medical device recall GE Healthcare Senographe Essential System GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the… Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas and Wisconsin named
- Medical device recall Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are… Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Colorado, Florida, Illinois, New Jersey, New York, Pennsylvania, Utah and Wisconsin named
- Medical device recall Medtronic, Launcher Guiding Catheter Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation leaking pouches Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRUE Dilatation Balloon Valvuloplasty Catheter Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNew Jersey
- Medical device recall CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient… GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal… As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension… Class IIIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Sarns “ TCM II Temperature Control Module The Sarns” TCM II Temperature Control Module is a source of… Internal testing found certain Sarns” TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNo state named
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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