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 Cobalt MV 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
- Medical device recall Cobalt MV with Gentamicin, Cobalt 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
- Medical device recall Cobalt HV with Gentamicin, Cobalt 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
- Medical device recall Delta Cup Beater Positioner - Aligner An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to… Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 15, 2017ClassClass IIStatusCompletedWhereNo state named
- Medical device recall AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO. Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16” which were subsequently recalled by CR Bard for a potential sterile barrier… Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereSouth Carolina
- Medical device recall Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx The recommended storage temperature on the label is incorrect. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Electrohydraulic lithotripter probe, 1.9 FR 375 cm The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereMassachusetts, Nebraska and Tennessee
- Medical device recall VITEK2 GP-ID Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R)… Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Georgia, Louisiana, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas and Utah named
- Medical device recall FlexFlow Venous Cannula A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RESONATE EL ICD VR The devices have an incorrect firmware configuration. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereMinnesota and Ohio
- Medical device recall RESONATE EL ICD DR The devices have an incorrect firmware configuration. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereMinnesota and Ohio
- Medical device recall VIGILANT X4 CRT-D The devices have an incorrect firmware configuration. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereMinnesota and Ohio
- Medical device recall MOMENTUM X4 CRT-D The devices have an incorrect firmware configuration. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereMinnesota and Ohio
- Medical device recall RESONATE X4 CRT-D The devices have an incorrect firmware configuration. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereMinnesota and Ohio
- Medical device recall Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate… Intermittent communication between the host system and the Flex Cardio Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report30 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for… After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were… Class IIFDA’s classNov 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c)… Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusCompletedWhereCalifornia, Illinois, North Carolina and Vermont
- Medical device recall NucliSENS Lysis Buffer Extended Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS)… Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereColorado, Maryland and Ohio
- Medical device recall RX-2 COUDE Epidural Needle, 16g x 3.5in Potential for partially incomplete seal of product, impacting sterility. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Iowa, Indiana, Kentucky, Louisiana, Michigan, New York, Ohio, Oregon, Tennessee, Texas and Washington
- Medical device recall COUDE Blunt Nerve Block Needle, 10 units, 0.71mm Potential for partially incomplete seal of product, impacting sterility. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Iowa, Indiana, Kentucky, Louisiana, Michigan, New York, Ohio, Oregon, Tennessee, Texas and Washington
- Medical device recall TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile Potential for partially incomplete seal of product, impacting sterility. Class IIFDA’s classNov 15, 2017in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 15, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Iowa, Indiana, Kentucky, Louisiana, Michigan, New York, Ohio, Oregon, Tennessee, Texas and Washington
- Medical device recall THERMI250 Radiofrequency System In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement Report25 statesnamed in where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Alcon Custom Pak Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereMissouri, New York and Wisconsin
- Medical device recall THERMOCOOL SMARTTOUCH SF Uni-Directional Biosense Webster, Inc. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall THERMOCOOL SMARTTOUCH SF Bi-Directional Biosense Webster, Inc. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S) Biosense Webster, Inc. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) Biosense Webster, Inc. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall THERMOCOOL SF NAV Catheters Biosense Webster, Inc. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CADD(TM) Medication Cassette Reservoir with clamp and female Luer Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For… Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate. Class IIFDA’s classNov 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on… Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall EMPOWR PS KNEE(TM) e+ It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EMPOWR PS KNEE(TM) e+ It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm The item is being recalled due to an inadequate pouch seal. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Kansas, Louisiana, Maryland, Maine, Missouri, Puerto Rico and Texas named
- Medical device recall BARD MAX-CORE Disposable Core Biopsy Instrument During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to… Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting… There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower… Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 1, 2017ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medical device recall Power Processor 1K Stockyard Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading… Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Torque wrench used on the bolts for the Symbia T2 The torque wrench used to tighten system bolts during installation was found to be out of tolerance Class IIFDA’s classNov 1, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Louisiana, New York, Pennsylvania and Tennessee
- Medical device recall GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure. Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal… The US FDA has requested the optional energy treatment settings, “medium” and “low” (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm… Class IIFDA’s classNov 1, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, North Carolina, New Jersey, New York and Texas
- Medical device recall Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V Incorrect source step size may occur in the software plans Class IIFDA’s classNov 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal… During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems… During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass 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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