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 LapSac Surgical Tissue Pouch Includes Information not stated in the intended use. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJul 1, 2015ClassClass 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 Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SERFAS 90 degree Energy Probe Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EVAC 70 XTRA with Integrated Cable Potential component failure causing device inoperability Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PROcise XP Wand with Integrated Cable Potential component failure resulting in inoperability Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fios First Entry Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in… Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Optical Access System Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in… Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cannula and Seal Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in… Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error. Class IIIFDA’s classJul 1, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 1, 2015ClassClass IIIStatusTerminatedWhereArizona, California, Idaho, Missouri and New Hampshire
- Medical device recall VersaTREK Instrument Series 240 Use of the recalled product may result in false positive reports. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Colorado, Florida, Georgia, Iowa, Idaho, Louisiana, Michigan, Missouri, Puerto Rico, Tennessee, Texas, Virginia and Washington named
- Medical device recall VersaTREK Instrument Series 528 Use of the recalled product may result in false positive reports. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Colorado, Florida, Georgia, Iowa, Idaho, Louisiana, Michigan, Missouri, Puerto Rico, Tennessee, Texas, Virginia and Washington named
- Medical device recall IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months)… Class IIFDA’s classJul 1, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereFlorida, New Mexico and New York
- Medical device recall Volcano PV .035 Catheter During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not… Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prestige Plus 185cm J-Tip During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not… Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee/ zeego systems There exists a possible position sensor fault in the swivel base axis not being detected by the system software. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neusoft NeuViz 64 Multi-slice CT Scanner System The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereIllinois, Massachusetts, Puerto Rico, South Carolina and Texas
- Medical device recall HeartWare Ventricular Assist System (HVAD) Complaints with the HVAD Internal Controller Alarm Battery failures. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedJun 24, 2015ClassClass IStatusOngoingWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Medtronic Passive Planar Blunt Probe Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereCalifornia, Louisiana, Missouri and Pennsylvania
- Medical device recall I-Portal¿ NOTC and VNG complaints of system malfunction and unintended, sudden movement at start up. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ELI 380 Electrocardiograph Mortara Instrument, Inc. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Michigan, Nebraska, South Carolina, Utah, Washington and Wisconsin
- Medical device recall Amerigel Hydrogel Gauze Dressing 2 x 2, A5002 Nonapproved labeling claims (Sterile) Class IIFDA’s classJun 24, 2015in FDA’s Enforcement Report45 statesnamed in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. The Left and Right orientation of the trial was incorrectly etched on one side. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereIllinois and New Jersey
- Medical device recall Pull Reduction Device For 4.3mm Percutaneous Drill Guide Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in… Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single… Potential breach in sterility Class IIFDA’s classJun 24, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereMaryland, Missouri, Mississippi, North Carolina and Texas
- Medical device recall BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kentucky, Michigan and New Jersey named
- Medical device recall BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kentucky, Michigan and New Jersey named
- Medical device recall BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kentucky, Michigan and New Jersey named
- Medical device recall BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kentucky, Michigan and New Jersey named
- Medical device recall BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kentucky, Michigan and New Jersey named
- Medical device recall Philips Ultrasound Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study… Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL Incorrect labeling of the expiration date Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera,… Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main… Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Massachusetts, Michigan, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Washington and Wyoming named
- Medical device recall Alaris PC unit An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially… Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CADD¿- Solis Ambulatory Infusion Pump Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD¿-Solis pumps. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall MILEX OMNIFLEX DIAPHRAGM SIZE 80 A diaphragm size 80 labeled box was incorrectly packaged with a size 85. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereAlaska, California, District of Columbia, Florida, Illinois, Maine, Montana, Nebraska, New Jersey, New Mexico, New York, Oklahoma, Oregon and Wisconsin
- Medical device recall Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Viper LT System Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD… Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportLouisianathe one state its words name PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereLouisiana
- Medical device recall CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08 Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface… Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Viking M, L, and XL Mobile Lifts Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Delaware, Idaho, Illinois, Indiana, Massachusetts, Montana and Tennessee
- Medical device recall GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW) Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMaryland, Montana, North Carolina, New Jersey, New York and Utah
- Medical device recall HeartWare Ventricular Assist System (HVAD) HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJun 17, 2015ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia named
- Medical device recall M/L Taper with Kinectiv¿ Technology Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv¿ femoral stems and modular necks due higher than allowed… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJun 17, 2015ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia… In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 17, 2015in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 17, 2015ClassClass IStatusTerminatedWhereAlabama, Arizona, District of Columbia, Florida, Michigan, Missouri, New Jersey, New York, Oregon, Pennsylvania, Texas and West Virginia
- Medical device recall EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004 Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002 Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope… Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass 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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