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 Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way,… The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could… Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, 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 and Wisconsin named
- Medical device recall 8.5mm Reamer Head for Flexible Intramedullary Nailing System The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot… Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Triathlon PS X3 Tibial Insert Stryker Orthopaedics received a report that 5537-G-319 No 3. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for… Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18 A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perfectum Tuberculin Glass Syringe, Non sterile Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Micro-Mate Tuberculin Glass Syringe, Non-sterile Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an… The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Wall Chart for STERRAD 100NX System, P/N 10104 Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states “APTIMAX Instrument Trays can be… Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004 AngioJet products were distributed with an incorrect use-by (expiry) date. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereArizona, Missouri and Ohio
- Medical device recall AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001 AngioJet products were distributed with an incorrect use-by (expiry) date. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereArizona, Missouri and Ohio
- Medical device recall AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001 AngioJet products were distributed with an incorrect use-by (expiry) date. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereArizona, Missouri and Ohio
- Medical device recall AngioJet AVX Thrombectomy Set: UPN 105039-001 AngioJet products were distributed with an incorrect use-by (expiry) date. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereArizona, Missouri and Ohio
- Medical device recall Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and… The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the wall bracket has cracked or broken. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California and Florida named
- Medical device recall Celsite Implantable Access Port System The manufacturer, B. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereCalifornia and New York
- Medical device recall Olympus Scientific Solutions Americas Analytical X-ray System Higher than published scatter around the probe head when testing some samples. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EnVeo R Loading System Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Beacon Tip Torcon NB Advantage Catheter Reports of catheter tip splits and or separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2015ClassClass IStatusTerminatedWhereNationwide, and Georgia, Puerto Rico and US Virgin Islands named
- Medical device recall Beacon Tip Royal Flush Plus High-Flow Catheter Reports of catheter tip splits and or separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2015ClassClass IStatusTerminatedWhereNationwide, and Georgia, Puerto Rico and US Virgin Islands named
- Medical device recall Slip-Cath Beacon Tip Catheter Reports of catheter tip splits and or separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2015ClassClass IStatusTerminatedWhereNationwide, and Georgia, Puerto Rico and US Virgin Islands named
- Medical device recall Medtronic Passive Biopsy Needle Kit The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Passive Biopsy Needle Kit The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall S4C Occiput Torque Wrench F/Set Screw A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion… Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not ‘locking’. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Indiana, Massachusetts, New York, Oklahoma, Oregon and Texas
- Medical device recall Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a… Multiple software and hardware issues with device that can affect its function. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall S2 Fluid Pack on the Cobas b 221 system The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereConnecticut, Kentucky, Louisiana, Michigan, North Dakota, New Jersey, Ohio, Oklahoma, Puerto Rico, South Carolina and Texas
- Medical device recall Biograph mCT S(40)-4R Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Biograph mCT S(64)-4R Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Biograph mCT X-4R Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall SYS IVK, Bio mCT-S(40) 3R->4R Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Biograph mCT Flow Edge-4R Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Biograph 6-4R TruePoint w/ TrueV Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Biograph 64-4R TruePoint w/ TrueV Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Biograph 64-3R TruePoint w/ TrueV Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall GE Healthcare, Signa Infinity MR System A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient… Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Artis zee systems The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q systems The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and… The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the on-screen… Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Battery Power Line II Oscillator Saw head separated from the drive unit or began to come loose. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereArkansas, Louisiana, Ohio and Washington
- Medical device recall Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter Class IIFDA’s classAug 12, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereArizona, California, Indiana, Louisiana, North Carolina, Tennessee, Texas and Virginia
- Medical device recall Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2… A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Louisiana, Massachusetts, Maine, Michigan, Missouri, North Carolina, North Dakota, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Hamilton-G5 Ventilators with software versions V2.40/2.41 Customer reports that the ventilator display can freeze. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InjectionPlasty 1.0 Bone Void Filler Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 5, 2015ClassClass IIStatusTerminatedWherePuerto Rico
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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