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 8, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall EkoSonic Endovascular System The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereArizona, California, Massachusetts, Michigan, Ohio and Virginia
- Medical device recall Flexor Check-Flo Introducer, Catheter introducer Incorrect packaging. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, New Jersey, New York, Ohio, Oklahoma and Texas
- Medical device recall PRN 50-M+, GE The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone… During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HipLOC CHS Plate/Lag Screw Introducer A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereArizona, Georgia, Illinois, Kentucky, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Pennsylvania and Utah
- Medical device recall Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips The clip in the applier may be missing a boss. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereCalifornia, Michigan, North Carolina, Pennsylvania, Texas and Virginia
- Medical device recall Fresenius Naturalyte Liquid Acid Concentrate On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereKansas, Louisiana, Mississippi, Oklahoma and Texas
- Medical device recall Mammomat Inspiration with Tomosynthesis functionality A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EndoVive 3s Low Profile Balloon Kits A feeding (reflux) valve leakage issue. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts 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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