Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and… Punctured blister packages were detected during the packaging process at the manufacturing site. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNew Mexico, Pennsylvania and Texas
- Medical device recall Elcam Medical MANI 3G Plate BLS RAD B.BRAUN Punctured blister packages were detected during the packaging process at the manufacturing site. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNew Mexico, Pennsylvania and Texas
- Medical device recall Maryland Dissector In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medium -Large Clip Applier In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cadiere Forceps In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Needle Driver In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fundus Grasper In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Crocodile Grasper In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maryland Bipolar Forceps In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curved Needle Driver In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fenestrated Bipolar Forceps In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were… Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Indiana, Missouri, North Carolina, New York, Ohio and Wisconsin named
- Medical device recall MicroVue Bb Plus EIA is Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereAlabama, Colorado, Connecticut, Florida, Kentucky, Minnesota, North Carolina, Nevada, Ohio, Pennsylvania and Washington
- Medical device recall FIRMap 60mm Catheter The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. Class IIIFDA’s classSep 9, 2015in FDA’s Enforcement Report19 statesnamed in where it went PublishedSep 9, 2015ClassClass IIIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This… When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COULTER LH Series Diluent Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall COULTER ISOTON 4 Diluent Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall Contour Next Control Solution for Contour Next Blood Glucose Test System If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vision RingLoc Shell 50 mm Size 23 The device was assembled without screw hole plugs. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bright Embrace, a Single Bili Light for newborn phototherapy Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions Class IIFDA’s classSep 9, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Kentucky, Massachusetts, Maryland, New Mexico, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml A reduction in the reconstituted stability has been identified. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Illinois, Kentucky, Michigan, Minnesota, New Jersey and Pennsylvania named
- Medical device recall VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports The last hole on certain VEPTR Inferior Cradles may be partially formed. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow International, Inc saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Minnesota, New Jersey, New Mexico, Ohio and Wisconsin
- Medical device recall Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNew York, Ohio and Texas
- Medical device recall KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) A tracheobronchial suction… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) A… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201358) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece MDI Adapter, 14F (Product Code… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) A… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A tracheobronchial suction… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A tracheobronchial suction… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210) A… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227) The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) A tracheobronchial suction… The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or… Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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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