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 RAPIDPoint 405 Blood Gas Analyzer Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall RAPIDPoint 500 Blood Gas Analyzer Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall RAPIDLab 1245 System Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall RAPIDLab 1265 System Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass… Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap… Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap… Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Maine, New Jersey, Texas and Washington named
- Medical device recall Synthes Inserter for Titanium Elastic Nails The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer… A false negative result affecting the diagnosis may occur. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile)… The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Hand-held Barcode Scanner In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a… Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Carton: Richard-Allan Scientific CYTO-STAIN The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. Class IIIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 18, 2015ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall MAX-TL 9.0 x 7.0 mm Implant Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial,… An increase in complaints of loosening and radiolucent lines. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0 Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, South Carolina and Texas named
- Medical device recall Philips Medical System Allura Xper X-Ray Angiographic In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200 Reports of formation of char adherent to the proximal part of the distal tip electrodes FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 11, 2015ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Xoran MiniCAT X-ray imaging device Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RotoRest Delta Advanced Therapy System The recalled devices labeling and instructions for use contain unapproved medical claims. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rotoprone Therapy System The recalled devices labeling and instructions for use contain unapproved medical claims. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TriaDyne Proventa Critical Care Therapy System The recalled devices labeling and instructions for use contain unapproved medical claims. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip,… PMMA coating does not meet specifications. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile Defect: A hole or crack was found which may cause air to leak. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Louisiana, Massachusetts, Minnesota, Mississippi, New Mexico, New York, Oklahoma and Texas
- Medical device recall KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr Defect: A hole or crack was found which may cause air to leak. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Louisiana, Massachusetts, Minnesota, Mississippi, New Mexico, New York, Oklahoma and Texas
- Medical device recall KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr Defect: A hole or crack was found which may cause air to leak. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Louisiana, Massachusetts, Minnesota, Mississippi, New Mexico, New York, Oklahoma and Texas
- Medical device recall Ikaria, INOmax DSIR (Delivery System) Potential delivery failure alarm condition. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Idaho, Louisiana, Maryland, Michigan, Mississippi, New Hampshire, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Texas, Utah, Virginia and West Virginia named
- Medical device recall Servo-I ventilator system CO2 analyzer A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module’s internal… Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000) There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in… Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance… The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports… Class IIIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 11, 2015ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall ADVIA Centaur Systems Progesterone Kit ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L) Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall ADVIA Centaur Systems Progesterone Kit ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L) Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall ADVIA Centaur Systems Progesterone Kit ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L) Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Oxoid Legionella BCYE Growth Supplement SR0110A Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereMichigan, North Dakota, South Carolina, Tennessee and Texas
- Medical device recall ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zip 8i Surgical Skin Closure Device The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zip 8M Wound Closure Device The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zip 16 Surgical Skin Closure Device The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monaco radiation therapy treatment planning system Incorrect CT to ED when using the Monaco Image Statistics Tool. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Incorrect size printed on the Milex Pessary Kit packaging label Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The I-Cart is used to store, transport, and power video equipment used in medical procedures. The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart… Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LFT v40 Femoral Head Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral… Class IIFDA’s classMar 11, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereGeorgia, Massachusetts, North Carolina, New York and Pennsylvania
- Medical device recall LASSO NAV Duo Loop eco Catheters Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 A device malfunction may cause the biopsy needle to fail to reach the intended target. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Focal Sim radiation therapy treatment planning system Incorrect CT to ED when using the Monaco Image Statistics Tool. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall AMIA v1.0 APD System Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Massachusetts, North Carolina, New York, Pennsylvania and Washington named
- Medical device recall SMARTSET GHV Gentamicin Bone Cement One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, Montana, North Carolina, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and West Virginia 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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