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 LAPAROTOMY PACK CUSTOMED 7/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 MAYO STAND COVER W/CSR WRAP 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 OPHTHALMIC PACK 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 HIP ORTHO. 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 OPHTHALMIC PACK 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 ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED 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 HIGADO Y PANCREA 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 SHOULDER PACK CUSTOMED 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 ANGIOGRAPHY 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 GAUZE SPONGES 2”x2” 4 PLY ST 2/PK 1500PK/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 GAUZE SPONGE 2”X2” 8PLY COTTON 1500PK/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 GAUZE 2” X 2” PRODUCTION ONLY 1500PK/CS CUSTOMED 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 ANGIOGRAPHY PACK CUSTOMED 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 KNEE ARTHROSCOPY 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 FEMORAL 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 LITHOTOMY 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 SHOULDER ARTHROSCOPY PACK 3/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 SURGICAL PACK 20/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 EAR PACK 3/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 NEURO 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-COLORECTAL SURGICAL PACK 2/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 CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/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 LUMBAR 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 EAR PACK 3/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 EXTREMITY ARM PACK 4/CS HOSP 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 (1) (2) 10/CS CUSTOMED 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 EENT PACK I (1) 10/CS CUSTOMED 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 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 MINOR 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 SHOULDER PACK (I) 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 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 O.B. PACK 5/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 GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED 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 GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED 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 GOWN COOL IMPEV 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 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 HIP AND KNEE REPLACEMENT 3/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 EXTREMITY 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 SHOULDER PACK 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 OPEN HEART PACK 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 FACE PACK MRT 8/CS CUSTOMED 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 TUMMY TUCK & BREAST PACK-RFMHI 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 SHOULDER ARTHROSCOPY PACK 2/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 REEMPLAZO DE RODILLA Y CADERA 2/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 SHOULDER 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 SUCTION CATHETER 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 URETHRAL CATHETER 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
- Medical device recall LAPAROTOMY SURGICAL PACK 3/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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