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 5, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size AA There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size BB There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size DD There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size EE There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size FF There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size GG There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size HH There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size JJ There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size KK There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size LL There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size MM There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size PP There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Constrained Condylar Offset Screw, Size RR There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico and Virginia
- Medical device recall ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical… Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended). Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereArkansas, Georgia, Michigan, Ohio and Texas
- Medical device recall ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and… Software corrections reactivating the cooperative endoscopy mode. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Georgia, Michigan, Ohio and Texas named
- Medical device recall Sensicare Green Surgical Glove, PI, LF, PF Possible open seal on top portion of the package. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement Report48 statesnamed in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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
- Medical device recall Transfer/Gait Belt, Plastic, Wipeable The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Transfer/Gait Belt, Plastic, Wipeable The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ARCHITECT c4000 The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Tubing, Peristaltic Head The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusCompletedWhereNo state named
- Medical device recall ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument… Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Massachusetts, Minnesota, North Carolina, New York, Ohio and Pennsylvania named
- Medical device recall Syngo.plaza, Picture Archiving and Communications System(PACS) Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereMinnesota
- Medical device recall Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a… Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS,… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedNov 29, 2017ClassClass IIStatusOngoingWhereTexas
- Medical device recall Tissu-Trans Filtron 1000 Potential breach of sterility of the packaging. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Reservoir Bag for WalkMed Infusion Pump There have been reported incidents of fluid leaks at the luer connection. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUIOS CL Flow Cytometer The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS) Class IIFDA’s classNov 22, 2017in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, North Carolina, New York, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas and Washington
- Medical device recall smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 22, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of… The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of… The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UFRA, size 1 printed on the patient label inside the box. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Louisiana, Maryland, North Carolina, Nevada, New York, Pennsylvania, South Dakota and Texas
- Medical device recall ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm Possible break in the connector of the Force Sensor. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Michigan, Ohio and Texas named
- Medical device recall smith&nephew TRIGEN INTERTAN 10S A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 22, 2017ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Illinois, Missouri and Tennessee
- Medical device recall STORZ High Flow Insufflation Tubing (with filter) The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm Observed instability of the device. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Michigan, New York, Ohio, Pennsylvania and Texas named
- Medical device recall ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm Potential failure of the optical distance sensor due to cable disconnection. Class IIFDA’s classNov 22, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereMichigan and Ohio
- Medical device recall Plum 360 Infusion System, List number 30010. (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the “Paused” state waiting for the distal pressure to decrease, the pump… Class IIFDA’s classNov 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ROSA Surgical Device 2.5.8 An undetected shift between the information displayed in the navigation software and the actual patient anatomy Class IIFDA’s classNov 22, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereMichigan, Ohio and Texas
- Medical device recall HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and… Class IIFDA’s classNov 22, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereCalifornia, Missouri, New York, Pennsylvania, Texas, Virginia and Wisconsin
- Medical device recall HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and… Class IIFDA’s classNov 22, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 22, 2017ClassClass IIStatusTerminatedWhereCalifornia, Missouri, New York, Pennsylvania, Texas, Virginia and Wisconsin
- Medical device recall North Star Imaging Inc. (NSI) It was discovered a low-level radiation leak that was found on the NSI X-7000 system. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusOngoingWhereKansas, Ohio and Pennsylvania
- Medical device recall Cobalt HV Bone Cement 40GM Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2017ClassClass IIStatusOngoingWhereNationwide
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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