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 5, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall MiniArc Pro Single incision Sling System The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Illinois, Kansas, Nebraska, New Jersey, New York, Ohio, Pennsylvania and Texas
- Medical device recall Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the ‘Verify Heartbeat Detection’ feature and exhibit potential for decreased… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Utah and West Virginia
- Medical device recall Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended… Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportVirginiathe one state its words name PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version… Instances of data sets not being accurately registered to the patient anatomy were observed. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereCalifornia, Kentucky, North Carolina, New Hampshire, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas and Washington
- Medical device recall Prism Medical C-300 Consumer Ceiling Lift Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prism Medical P-300 Portable Consumer Lift Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA Sterility of the product cannot be assured. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus Sterility of the product cannot be assured. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus Sterility of the product cannot be assured. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus Sterility of the product cannot be assured. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CIVCO Sales Demo Kit Sterility of the product cannot be assured. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD)… Loud operating sounds, which was unacceptable to the end users when the device was powered on. Class IIIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 25, 2015ClassClass IIIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase… There is a risk ECG electrodes of specific lots fail to transmit signals. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportFloridathe one state its words name PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101 Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147 Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075 Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting… Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall 1 Step 12 Panel Cup Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10-Panel Pipette Drug Screen Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 11 Panel Cup (OPI2000) w/Adult Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 11 Panel Dip Card (OPI 2000) Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 12-Panel Dip Drug Screen with adulterant Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ArcPoint Labs 10 Panel Dip Screen (OXY) Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration) Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DrugCheck Pipette 10 Drug Test Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DrugCheck Waived 12 Panel Cup w/Adult Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart 10 Test Cup (PCP & MDMA) Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart 11 Test Cup Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EDI BZO UNCUT SHEET-CARD Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iCup Drug Screen Cup Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Immutest 10 Pnl Drug Screen Cup w/ Adult Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Micro Screen 6 Panel Cup with Adult (AU) Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Premier Clia Waived 12 panel Tilt Cup Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 10 Drug Panel Cassette Test Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU) Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall THERMO FISHER 6 DRUG CASSETTE Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SilverStat, sterile 2” x 2 “ calcium alginate hemostasis pad with sliver nitrate During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k Class IIFDA’s classNov 25, 2015in FDA’s Enforcement Report18 statesnamed in where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Georgia, Iowa, Maryland, North Carolina, Nebraska, New Hampshire, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah and West Virginia
- Medical device recall Villa Sistemi Rotograph EVO 3D X-ray It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Owandy Radiology I -MAX Touch 3D X-ray It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 18, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 18, 2015ClassClass IStatusTerminatedWhereArizona, California, Delaware, Florida, Georgia, Illinois, Louisiana, Maryland, Michigan, Minnesota, Nebraska, New York, Pennsylvania, South Carolina, Texas, Washington and Wisconsin
- Medical device recall RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 18, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 18, 2015ClassClass IStatusTerminatedWhereArizona, California, Delaware, Florida, Georgia, Illinois, Louisiana, Maryland, Michigan, Minnesota, Nebraska, New York, Pennsylvania, South Carolina, Texas, Washington and Wisconsin
- Medical device recall Boston Scientific SQ-RX Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereMassachusetts and Puerto Rico
- Medical device recall Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a… Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where… Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT… Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades,… It was reported that packaging was not properly sealed. Class IIFDA’s classNov 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming 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.”
Your shortlist0 of 4
Add one more to compare.