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 Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gelseal Straight Diameter 8mm Length 15cm Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Gelseal Straight Diameter 8mm Length 30cm Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement… Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Indiana, Kansas, Louisiana, Minnesota, Montana, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Utah and Wisconsin
- Medical device recall DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System),… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label,… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereFlorida and New York
- Medical device recall HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are… Complaints with the HVAD Abnormal Power Source Switching. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 8, 2015ClassClass IIStatusOngoingWhereAlabama, 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 StoneLight 30 Laser System (NS3000) During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Illinois, Massachusetts, Michigan and Ohio
- Medical device recall LifeHealth, IRMA TRUPOINT The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Cholesterol CHOD-PAP Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cholesterol Gen.2 Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Creatinine Plus Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Creatinine Plus ver. 2 Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HDL-Cholesterol gen.3 Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HDL-Cholesterol plus gen.3. Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR… Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LDL-Cholesterol gen.2 Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LDL-Cholesterol plus gen.2 Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Triglycerides GPO Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Triglycerides/Glycerol Blanked Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and… Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ICT Serum Calibrator ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SOMATOM Emotion 16 A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Emotion 6 A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000 Chest drains have a missing o-ring Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100 Chest drains have a missing o-ring Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100 Chest drains have a missing o-ring Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N Chest drains have a missing o-ring Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sechrist Low Profile Wheeled Stretcher Sechrist Industries is recalling the Sechrist Low Profile Wheeled Stretcher because it may experience an unexpected incline angle during the height adjustment… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Accurus 2500 Standalone Vitreous Probe Insufficient seal on the outside packaging, potentially affecting the sterility of the product. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter One lot of the Extractor” Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall EasyLink Data Management System System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Velocity” Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to… The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, Massachusetts, Ohio, Texas and West Virginia named
- Medical device recall Gentle Threads Interference Screw 10x25mm Round Head Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Gentle Threads Interference Screw 9x35mm Full Thread Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Pennsylvania and Washington named
- Medical device recall Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US QC results were out of range resulting in false resistant strains. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185 Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall INSTRUMENT ARM DRAPE, IS4000, 20 PACK Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 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.”
Your shortlist0 of 4
Add one more to compare.