Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall BD-Retic-Count Reticulocyte Reagent System The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. Class IIIFDA’s classApr 20, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 20, 2016ClassClass IIIStatusTerminatedWhereCalifornia, Connecticut, District of Columbia, Florida, Indiana, Massachusetts, Minnesota, New York, Utah and Virginia
- Medical device recall X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized… The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Idaho, Louisiana, Maryland, Nebraska, New Mexico, Ohio, Oregon, Pennsylvania, Tennessee, Virginia and Washington
- Medical device recall Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10… The label on the outer packaging does not match the product inside and intended use of the device. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNorth Dakota and Ohio
- Medical device recall RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlabama, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Michigan, Missouri, Mississippi, North Carolina, New York and Texas
- Medical device recall VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical… Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring… Complaints were received of restricted/inaccurate flow rate. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles… Bard Peripheral Vascular, Inc. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Iowa, Kansas, Massachusetts, Michigan, Missouri, Montana, Nevada, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical procedures and patient… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and patient care… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical procedures and patient care… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001574 LEGGINS 30X42 W/7” CUFF Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900169 UNIVERSAL SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWherePuerto Rico
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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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