Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk Lint present on sterile Operating Room Towels. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusOngoingWhereArkansas, Indiana and Nevada
- Medical device recall Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk Lint present on sterile Operating Room Towels. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusOngoingWhereArkansas, Indiana and Nevada
- Medical device recall 16 mm Distraction Pin, Titanium, Qty: 1 per pack Product’s non-conformity involves the integrity of the seal in the sterile packaging. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack Product’s non-conformity involves the integrity of the seal in the sterile packaging. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10 mm Distraction Pin, Aggressive Qty: 1 per pack Product’s non-conformity involves the integrity of the seal in the sterile packaging. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 14 mm Distraction Pin, Exagg Qty: 1 per pack Product’s non-conformity involves the integrity of the seal in the sterile packaging. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 12 mm Distraction Pin, Blunt Qty: 1 per pack Product’s non-conformity involves the integrity of the seal in the sterile packaging. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall WECK Visistat 35R Disposable Skin Stapler Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusCompletedWhereCalifornia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, North Carolina, New Jersey, New York, Ohio, Oregon, Rhode Island, Texas, Utah and Virginia
- Medical device recall Brennen Skin Graft Mesher Sterilization validation failure. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341:… the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportColoradothe one state its words name PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereColorado
- Medical device recall OVATIO Models: VR 6250, DR 6550, CRT 6750 Sorin is notifying physicians that certain defibrillators’ battery depletion may be undetectable. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770… Sorin is notifying physicians that certain defibrillators’ battery depletion may be undetectable. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250,… Sorin is notifying physicians that certain defibrillators’ battery depletion may be undetectable. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty. Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereCalifornia, Hawaii, Indiana, Minnesota, New Jersey, Pennsylvania, Virginia, Washington and Wisconsin
- Medical device recall Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap A Discrepancy was found on Hitachi AST (HA7 61) package insert. Class IIIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE This lot of left plates were laser etched and packaged as right plates. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory… Potential Patient Demographic Error with Blank Patient ID Field Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm Some eyelets broke from SwiveLock Anchor on insertion. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching Some eyelets broke from SwiveLock Anchor on insertion. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportOklahomathe one state its words name PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereOklahoma
- Medical device recall NDI P7 Position Sensor, Stereotaxic Instrument Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Louisiana, Mississippi, New Jersey, Washington and Wisconsin
- Medical device recall Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311… Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY Product sterility compromised due to breach in sterile barrier package Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CooperSurgical lnflatoball Latex Rubber Pessary The current secondary packaging, a box, incorrectly states that the product is latex free. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 17, 2017ClassClass 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, Montana, 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 Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397 Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean” Linear Broach Handle. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereTexas
- Medical device recall MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening… Indications for use are not cleared or approved for market in the U.S. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereAlabama and New Jersey
- Medical device recall Medi-Therm Hyper/Hypothermia System, MTA7900 The water may reheat too quickly if the unit is in “Automatic” mode, switched to “Manual” mode to view water temperature, and then switched back to “Automatic”… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bone Dowell Harvest Tubes mislabeled as 8mm tube but it is actually 9 mm in size. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Savaria SL-1000 Stairlift The electrical controller, combined with motor, causes feedback, damaging a component on the control board, starting a fire. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701,… Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Healon 5 Pro Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Healon Pro, Part No. 10270012 Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Healon V, Part No. 10290045 Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX… pegs shearing post-operatively Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Microfil Composite Instruments are Microfil Composite Instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant Missing Dome Pack accessory. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Illinois, Indiana, Michigan, North Carolina, New York, Ohio and Oklahoma
- Medical device recall Stryker PROFESS Registration Kit Product shipped proximate to or past the expiration date listed on the product label. Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Georgia, Illinois, Indiana, Massachusetts, Maryland, North Carolina, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall Newport Medical HT70 and HT70- Plus Ventilators Medtronic is issuing a voluntary field corrective action for all its Newport” HT70 and Newport” HT70 Plus ventilators because they may shutdown spontaneously… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE Complaints regarding broken blister. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereArizona, Minnesota and Tennessee
- Medical device recall The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the… This field action is being initiated following the firm’s discovery of a procedural error in the approval of literature resulting in the undo release of… Class IIIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIIStatusTerminatedWhereNationwide
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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