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 6, 2026.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arm and Hammer Spinbrush Pro White Sonic Toothbrush Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arm and Hammer Spinbrush Pro Clean Sonic Recharge Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to… Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCESSORY BASE STARTER KIT,IS3000 Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smiths Medical, Medfusion¿ Syringe Infusion Pump Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 8, 2012in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 8, 2012ClassClass IStatusTerminatedWhereCalifornia
- Medical device recall Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre… As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking:… Digital Skin Mammography Marker separating from the backing of the spot material Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking:… Digital Skin Mammography Marker separating from the backing of the spot material Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking:… Digital Skin Mammography Marker separating from the backing of the spot material Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital… Digital Skin Mammography Marker separating from the backing of the spot material Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Padded Swing Away Arm Rest with Receiver Reports of injury when the Padded Swing Away Armrest is used for full body weight. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product… The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Ohio, Oklahoma and Texas named
- Medical device recall Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty Exactech, Inc. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement Report27 statesnamed in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty. Exactech, Inc. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement Report27 statesnamed in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty. Exactech, Inc. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement Report27 statesnamed in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder… Exactech, Inc. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement Report27 statesnamed in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty. Exactech, Inc. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement Report27 statesnamed in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at… Exactech, Inc. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement Report27 statesnamed in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Perkin Elmer Genetic Screening Processor (GSP) Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in… To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close confirmation button and door open delay will be installed on… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The… Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall IRISpec” CA/CB two-part urine chemistry control twin set, Iris Diagnostics The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the… Class IIIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall OEC 9800 Plus Digital Please be aware that this is not a new recall. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OEC MiniView 6800 Mobile Please be aware that this is not a new recall. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UroView 2800 Please be aware that this is not a new recall. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall High Pressure Stopcock The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For… The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 94” (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with… Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Ohio, Pennsylvania and Virginia named
- Medical device recall I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RF Cannula, 100 mm,Curved 5 MM, 20 G Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RF Cannula, 100 mm,Curved 10 MM, 20 G Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or… The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 1, 2012in FDA’s Enforcement Report16 statesnamed in where it went PublishedAug 1, 2012ClassClass IStatusTerminatedWhereArizona, California, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Texas and Wisconsin
- Medical device recall OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650… Please be aware that this is not a new recall. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 1, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2012ClassClass IStatusTerminatedWhereNo state named
- Medical device recall OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and… Please be aware that this is not a new recall. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 1, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2012ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Leica M525 F50 Surgical Microscope Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Texas, Utah and West Virginia 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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