Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall TRACH PACK. Sterile Procedural Tray. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LOCAL PACK. Sterile Procedural Tray. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Tray, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall UNIVERSAL CORE DR RUNNELS PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FEMORAL ARTERY PACK-LF Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: IM NAIL Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: LS MS PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sterile Procedural Trays, labeled as the following: a Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Identity Shoulder System Resection Planer 35mm Resection Planer Two planers were found to be unusable during sawbones shoulder training. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Illinois, Michigan, New Jersey, New York, Oklahoma, Pennsylvania, Texas and Washington named
- Medical device recall HIGH V+ Spinal Cement System Incorrect expiry date. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Mississippi named
- Medical device recall Precision Delivery Set with Filter Delivery Sets may have tubing that could become detached that could result in patient infection. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall RipCord Syndesmosis Button Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its… Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Florida, Georgia, Hawaii, Illinois, Kansas, Louisiana, Missouri, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide, and South Carolina named
- Medical device recall SPiN Thoracic Navigation System A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect… Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereFlorida, Georgia, Indiana, Maryland, Mississippi, New York, Ohio, Pennsylvania, Rhode Island, South Carolina and Virginia
- Medical device recall cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800… The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TrackX Insight Base Modular Instrument Tracker, 5L The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 15, 2023ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Louisiana, North Carolina, Pennsylvania, Virginia, Washington and Wisconsin named
- Medical device recall The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE… An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedFeb 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia 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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