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 Catalog Number: 9001780 OPHTHALMIC 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: 9001933 OPHTALMIC 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: 9001966 LIVER & PANCREAS SURGERY 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: 9002123 KNEE ARTHROSCOPY 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: 9002164 FEMORAL 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: 9002167 LITHOTOMY 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: 9002193 SHOULDER ARTHROSCOPY 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: 9002224 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: 9002256 NEUROSURGERY 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: 9002259A LAPAROSCOPY-COLORECTAL 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: 9002469 BASIC SURGICAL PACK IV 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: 9002510 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: 9002511 MINOR 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: 9002516 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: 9002609 ARTHOSCOPY 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: 9002614 HIP AND KNEE REPLACEMENT 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: 9002615 EXTREMITY 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: 9002618 OPEN HEART 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: 9002726 HIP AND KNEE REPLACEMENT 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: 9002766 SHOULDER 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: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff… 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: 900278 URETHRAL CATHETER TRAY 14FR 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: 900281A LAPAROTOMY 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: 9002829 BASIC SURG 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: 9002830 ORTHOPEDIC 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: 9002899 CYSTO TUR 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: 9002940 OBSTETRICAL 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: 9003190 SURG GOWN SMS AMMI IV FULL 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: 900345 BASIC 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: 900403 CESAREAN SECTION 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: 900410 CESAREAN SECTION 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: 900419 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: 900450 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: 900474 LAPAROSCOPY 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: 900484 LAPAROSCOPIC GYNECOLOGY 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: 900486 LAPAROSCOPY 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: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE Used by… 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: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by… 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: 900540 WOUND MANAGEMENT TRAY III 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: 900547 BASIC 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: 900548A 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: 900576A LAP-CHOLECYSTECTOMY 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: 900582 UTILITY DRAPE WITH TAPE, SMS 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: 900618A LAPAROSCOPY-GYN 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: 900629 STERILE OR CLOTH TOWEL BLUE 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: 900633 FAN FOLD SHEET 44 X 58 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: 900740A 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: 900741A ORTHO-IMPLANT 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
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.