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 BASIC PACK 8/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 ORTHOPEDIC PACK BASIC 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 CYSTO TUR PACK BASIC 8/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 OBSTETRICAL SURGICAL PACK 4/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 HAIR RESTORATION PACK-THR 12/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 BREAST PACK-BOD 6/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 FACE LIFT 4/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 TUMMY TUCK PACK-FJG 6/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 FACE PACK FJG 8/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 LAPAROSCOPY PACK 2/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 GOWN IMPERVIOUS EXTRA LONG 24/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 BREAST PACK-TPSC 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 BASIC PACK W/OUT GOWN 11/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 ANGIODRAPE PACK DAMAS 6/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 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 MAJOR LAP 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 CESAREAN PACK 2/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 LAPAROSCOPY CHOLE 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 GAUZE SPONGE 4”X4” 16 PLY SOFT 1280/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 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 CYSTO TUR 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 MINOR LAPAROTOMY 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 LAPAROSCOPY 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 LAPAROSCOPY OB 6/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 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 GOWN POLYREINF XLGE TOWEL/W 24/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 SURG GOWN POLYREINF LGE CUSTOM 28/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 GAUZE SPONGE 4”X4” 16 PLY XRD 1280/CS (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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall LAPAROTOMY BASIC PACK 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 PERY-GYN SURGICAL PACK 6/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 LAP-CHOLECYSTECTOMY 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall UTILITY DRAPE END PRODUCT 50PK/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 LAPAROSCOPY GYN PK CS/4 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 ANGIOGRAPHY PACK 5/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-GYN 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 classSep 9, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 9, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall ARTHROSCOPY 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 O.R. TOWELS 25/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 FANFOLD DRAPE 44”X58 60/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 PERI GYN 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 O.B. PACK HOSPITAL 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 CESAREAN 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 ARTHROSCOPY SURGICAL PACK 4/C 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 ORTHO-IMPLANT SURGICAL PACK, 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 CARPAL TUNEL LARGE SURGICAL PACK, 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 INCISION AND DRAINAGE TRAY 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 SKIN STAPLE REMOVER KIT 80/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 GENERAL MINOR PK 5/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 FEMORAL ANGIOGRAPHY PACK 4/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.
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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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