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 PERI GYN PACK CS/6 Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall ARTHROSCOPY PK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and patient care procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall TRACHEOTOMY CARE KIT CUSTOMED 50/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall FOLEY CATHETER KIT II 16FR Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall FOLEY CATHETER KIT II 18 FR 20/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall NEURO PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall WOUND MANAG.TRAY 24/CS Used by medical staff to perform surgical procedures and patient care procedures such… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall LAPAROSC. OB GYN PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall WOUND MANAGEMENT TRAY II 30/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall LAMINECTOMY PACK 3/C Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PREMIUM CESAREAN PACK CUSTOMED 5/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PREMIUM LAPAROTOMY PK CUSTOMED 6/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PREMIUM O.B. PACK CUSTOMED 5/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall NEURO SPINE PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PEDIATRIC LAP PACK 8/CS Used by medical staff to perform surgical procedures and patient care procedures such… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall WOUND MANAGEMENT CUSTOMED 20/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall UROLOGY CUSTOMED PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical procedures and patient care procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall E.N.T. PK 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall ANGIOGRAPHY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall D & C LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall FOLEY CATH KIT 16FR Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall DRESSING CHANGE CUSTOMED 50/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall LEGGINGS W/7” CUFF 30” x 42” 30/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall RETINA PACK 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall LAPAROS.CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient care procedures such… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall OPEN HEART TRAY CUSTOMED 1/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall PERI GYN PACK 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and patient care procedures… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as… Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall MINOR LACERATION TRAY CUSTOMED 50/CS 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
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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