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 Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF’s Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, Colorado, Michigan, Minnesota, North Carolina, Ohio and Texas
- Medical device recall Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - GelPort Laparoscopic System EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - Trocar VersaPort Plus V2 EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - Endo Catch 10mm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - Mayfield Disposable Skull Pin EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - Silicone Round Drain EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange -Suction Coagulator EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange -APPLIER, MULTICLIP ROTATING EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange -SYSTEM, TACKER SKIN 5MM EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange FIBERWIRE SUTURE SCISSOR EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange FEMORAL CANAL TIP EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange Insufflation Needle EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange 10MM VASCULAR EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange 12MM VASCULAR EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange PT WIRE 300 EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange X-SAW BLADE EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange Wire (sternotomy wire) EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange Round Fluted Bur Soft Touch EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange Round Diamond Bur Extra Coarse EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange Round Fluted Bur Aggressive EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange 3.5mm Threaded Cerclage Pin EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange 12x40 Airway Stent System EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange 10x40 Airway Stent System EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall Medical Device Exchange Aerosizer Stent Sizing Device EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida and Texas
- Medical device recall OxySure Model 615 disposable replacement cartridges, for portable oxygen generator. Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology 5 issues. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, West Virginia and Wyoming named
- Medical device recall Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System 5 issues. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, West Virginia and Wyoming named
- Medical device recall Computed Tomography X-ray Systems Brilliance iCT SP 5 issues. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, West Virginia and Wyoming named
- Medical device recall Computed Tomography X-ray Systems Ingenuity Core 5 issues. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, West Virginia 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.”
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