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 Access 2 Immunoassay System, Remanufactured Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Maryland, Michigan, Missouri, New Mexico, New York, Ohio, Texas, Utah and Virginia
- Medical device recall BioSync Anatomic Cotton Wedge, 16 x 4.5 mm. Potential for polystyrene particulate presence. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, North Carolina, New York, Pennsylvania, South Carolina, Virginia, Washington and Wisconsin
- Medical device recall BioSync Anatomic Cotton Wedge, 16 x 5.5 mm. Potential for polystyrene particulate presence. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, North Carolina, New York, Pennsylvania, South Carolina, Virginia, Washington and Wisconsin
- Medical device recall BioSync Anatomic Cotton Wedge, 16 x 6.5 mm. Potential for polystyrene particulate presence. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, North Carolina, New York, Pennsylvania, South Carolina, Virginia, Washington and Wisconsin
- Medical device recall BioSync Anatomic Cotton Wedge, 20 x 4.5 mm. Potential for polystyrene particulate presence. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, North Carolina, New York, Pennsylvania, South Carolina, Virginia, Washington and Wisconsin
- Medical device recall BioSync Anatomic Cotton Wedge, 20 x 5.5 mm. Potential for polystyrene particulate presence. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, North Carolina, New York, Pennsylvania, South Carolina, Virginia, Washington and Wisconsin
- Medical device recall BioSync Anatomic Cotton Wedge, 20 x 6.5 mm. Potential for polystyrene particulate presence. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, North Carolina, New York, Pennsylvania, South Carolina, Virginia, Washington and Wisconsin
- Medical device recall STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses. The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses). Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is… As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereColorado, Florida, Illinois, Michigan, New Jersey, New York, South Carolina, Texas and Virginia
- Medical device recall Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F… PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN… PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC… PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970 PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Excelsior Disposable Syringe Heparin Lock Flush, USP syringe Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO” are powered ambulance cots… Complaints of smoke coming from the foot end of the cot. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that… Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Kansas, Kentucky, Maryland, Michigan, Nebraska, Nevada, New York, Ohio, Oklahoma, Texas and Washington
- Medical device recall Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number… When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Universal Battery Charger II (UBC II) The device is reported to enter safe mode and is no longer able to charge batteries. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report27 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized… Product had torn/loose seal around the mouthpiece. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EVARREST Fibrin Sealant Patch Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters “0-bad” were printed in the expiration date field on the foil pouch labels of the… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are… The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined… The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are… The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are… The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Natus neoBLUE Phototherapy system, Catalogue The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide, and American Samoa, Guam and Puerto Rico named
- Medical device recall Small Patient ECC Pack Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0 In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Missouri, Ohio, Pennsylvania, Tennessee and Texas named
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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