Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability. Class IIIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Stryker XIA 3 TORQUE WRENCH Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker MANTIS TORQUE WRENCH Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677… Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall “***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report10 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Illinois, Louisiana, Mississippi, New Jersey, New York, Ohio, Pennsylvania and Utah
- Medical device recall “***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report10 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Illinois, Louisiana, Mississippi, New Jersey, New York, Ohio, Pennsylvania and Utah
- Medical device recall The RIO (TGS 2.) MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report33 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a… Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head… Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioPlant, a dental bone grafting material The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Freedom Cordless LED Light System The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall qube Compact Monitor (Patient Monitor) 91390 Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall INTRABEAM Balloon Applicator Set A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois and Maryland named
- Medical device recall INTRABEAM Balloon Applicator Set A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois and Maryland named
- Medical device recall INTRABEAM Balloon Applicator Set A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois and Maryland named
- Medical device recall Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Texas and Washington named
- Medical device recall Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an… Firm has received complaints from customers of “Abnormal Reaction” errors occurring on calibrations, QC and patient samples. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a… The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Georgia and Oklahoma named
- Medical device recall Multipolar¿ Bipolar Cup Liner 22 mm LD. Zimmer Inc. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Florida, Hawaii, Illinois, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania and Texas 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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