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 da Vinci Si Vision System Cart Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Hawaii, Montana, New York, Texas, Utah and Washington
- Medical device recall da Vinci Dual Camera Controller Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Hawaii, Montana, New York, Texas, Utah and Washington
- Medical device recall da Vinci Instrument Control Box Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Hawaii, Montana, New York, Texas, Utah and Washington
- Medical device recall GEO-MED ORTHO TOTAL JOINT TRACECART(R) DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Fresenius Service Replacement 0-Ring Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Maryland, North Carolina, New Jersey, New York, Pennsylvania, Puerto Rico, South Carolina, Texas and Virginia named
- Medical device recall Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography Firm became aware of an unintended behavior when using the Mammomat Inspiration. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and North Dakota, Ohio and South Carolina named
- Medical device recall REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy… Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in… Class IIFDA’s classJul 17, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereIndiana, North Carolina, Ohio and Pennsylvania
- Medical device recall Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and… The outer jacket is receding away from the black sensor prematurely. Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Innova 3100 and Innova 4100 systems GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report14 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Idaho, Illinois, Maine, North Carolina, Nevada, New York, Oklahoma, Tennessee, Utah and Wisconsin
- Medical device recall 20-Pole LASSO Nav Catheter Eco Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Minnesota and Utah
- Medical device recall StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. 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 GENESYS Cross FT Suture Anchor with Two #2 Incorrect blue/white suture was used. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Louisiana, Michigan, North Carolina and New York
- Medical device recall Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40 This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Montana, New Hampshire, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia and Washington named
- Medical device recall Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30 This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Montana, New Hampshire, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia and Washington named
- Medical device recall MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05 MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number… Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereArizona, Georgia, North Dakota, South Carolina, Tennessee and Texas
- Medical device recall -Instratek Carpal Tunnel Release Blades 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 - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm 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 ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm 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 GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36”, double-Armed w/CP 2 Needles 2 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
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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