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 American Surgical Delicot 9 mm x 50 mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Delicot 13 mm x 60 mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Delicot-J 13 mm x 60 mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Delicot 20 mm x 60 mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Delicot 30 mm x 70 mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Delicot-J 30 mm x 70 mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Delicot X 6 mm x 50 mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Delicot X 9 mm x 50 mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Uniqcot 1/4” x 1/4” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Uniqcot 1/2” x 1/2” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Uniqcot 1/2” x 1.5” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Uniqcot 1/2” x 3” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Uniqcot 1/2” x 2” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Cylindrical Sponges-Strung 1/2” x 1.5” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Telfa 3/8” x 3” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Telfa 1/2” x 1/2” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Telfa 1/2” x 1.5” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Telfa 1/2” x 3” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Telfa 3/4” x 3” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Telfa 1” x 1” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Telfa 1” x 3” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Policot 1/4” x 1/4” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Policot 1/2” x 1/2” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Policot 1/2” x 1.5” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Policot 1/2” x 2” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mass Eye & Ear Finger Cot Nasal 2’s Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PerFuse Decompression Instrument PN: 800-0541 The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Minnesota and Ohio
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Various trauma and sports medicine instruments and implants Insufficient seal strength on sterile barrier packaging. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve Potential for a product defect where the cannula may be obstructed. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, Michigan, Missouri, North Carolina, New York and Texas named
- Medical device recall cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient’s… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 25, 2016ClassClass IStatusTerminatedWhereNationwide, and Kansas, Missouri, North Carolina, Ohio and Virginia named
- Medical device recall ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The… Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereKentucky and Texas
- Medical device recall ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The… Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereKentucky and Texas
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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