Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Angiography Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Arthroscopy Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care procedures such as wound… Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Fanfold Drape Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Pery Gyn Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound… Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Cesarean Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Arthroscopy Surgical Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Carpal Tunnel Surgical Large Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Neuro Pack, Catalog # 900-752 Used by medical staff to perform patient care procedures such as wound healing,… Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall General Minor Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Femoral Angiography Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Laparotomy Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Cesarean Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Urology Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Arthroscopy Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall , Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture… Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Plastic Surgery Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall C-Section Surgical Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Cataract Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Strabismus And Plastic Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Arthoscopy Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Laparotomy Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Peri Gyn Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall C-Section Pack Significant compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall ADULT Radiotransparent Electrode, REF/Catalog Number 2001H Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ADULT Radiotransparent Electrode, REF/Catalog Number 2516H Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips… Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GDC-10 360 SOFT 3mm x 6cm SR Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNew Hampshire, Ohio, Texas and Virginia
- Medical device recall GDC-10 360 10mm x 30cm SR Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNew Hampshire, Ohio, Texas and Virginia
- Medical device recall GDC-18 360 20mm x 33cm Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNew Hampshire, Ohio, Texas and Virginia
- Medical device recall Target 360 Standard 12mm x 30cm Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNew Hampshire, Ohio, Texas and Virginia
- Medical device recall Gateway OTW 2.75mm x 9mm Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNew Hampshire, Ohio, Texas and Virginia
- Medical device recall The Artis zee / zeego Angiography System is designed as a set of components that may be combined into… There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by… Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film… Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cooper Surgical CANNULA-CURETTE 12MM The product has been identified to contain an incorrect curette type. Class IIIFDA’s classDec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IIIStatusTerminatedWhereMissouri, Nevada and New York
- Medical device recall Polyflux Revaclear Dialyzer Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that… Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Polyflux Revaclear Max Dialyzer Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that… Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector… Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GuardIVa Antimicrobial Hemostatic IV Dressing Bard Access Systems is recalling GuardIVa (Ref. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereArkansas, Louisiana, Oklahoma and Texas
- Medical device recall McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched… The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when… Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Georgia 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.