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 Hem-o-lok Large Polymer Ligating Clips Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide, and Nevada named
- Medical device recall LeVeen Standard Needle Electrode System, Sterile Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Leveen Coaccess Needle Electrode Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Leveen Coaccess Introducer Set Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) The manufacturer informed the recalling firm of a potential laser marking error in size identification on two Columbus 4-IN-1 Femoral Cutting Guide Instruments. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWherePennsylvania and Tennessee
- Medical device recall Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demineralized… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demineralized human… Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber) Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Baxter Interlink System Buretrol Solution Set, 117” Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Baxter Clearlink System Buretrol Solution Set, 115” Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Baxter Clearlink System Buretrol Solution Set, 115” Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Active Renin IRMA Kit The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereCalifornia, Connecticut and Ohio
- Medical device recall Flow Meter, CM Assembly Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Ultra PC% Cabinet Mount Package G Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall CM Flowmeter Pkg H Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Newport Portable Package Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Unicel DxH 800 Coulter Cellular Analysis System Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit… 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Connecticut, Georgia, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia, Washington and Wisconsin named
- Medical device recall PREVI Isola System The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas and Wisconsin named
- Medical device recall The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that… Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive… The tips of the drivers are breaking while being used to drive the screws into patients. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive… The tips of the drivers are breaking while being used to drive the screws into patients. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830… Sterility of the product may be compromised. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Massachusetts, North Carolina, New York, Ohio, Pennsylvania and Texas named
- Medical device recall Triage TOX Drug Screen Panel Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Massachusetts, Minnesota, Mississippi, North Carolina, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Caremor Cliner”***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No.… Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereArkansas, California, Maryland, Mississippi, New York and Pennsylvania
- Medical device recall Caremor Cliner is labeled in part: “***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No.… Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereArkansas, California, Maryland, Mississippi, New York and Pennsylvania
- Medical device recall CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5 The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TetraCXP Software System The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PREMIER(R) Anterior Cervical Plate System SCREW BLOCK Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IDS Urine BETA CrossLaps ELISA It has been noted by staff at IDS Inc. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Maine and New York named
- Medical device recall IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) It has been noted by staff at IDS Inc. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Maine and New York named
- Medical device recall IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set It has been noted by staff at IDS Inc. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Maine and New York named
- Medical device recall IDS-iSYS N-Mid¿ Osteocalcin It has been noted by staff at IDS Inc. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Maine and New York named
- Medical device recall IDS-iSYS N-Mid¿ Osteocalcin It has been noted by staff at IDS Inc. Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Maine and New York 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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