Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Covidien Vistec” X-Ray Detectable Sponges, 7317 Vistec” X-Ray Detectable Sponges Sponge Medtronic is voluntarily recalling two production lots of its Covidien Vistec” x-ray detectable sponges de to possible contamination with human blood caused by… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary… Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereCalifornia, Delaware and Iowa
- Medical device recall PowerPICC Provena Catheters, as 3 Fr Possible leaks on the 3 Fr. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781,… There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the… Class IIIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip… Wrong device description of the label identifying the implant Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Maryland and New York
- Medical device recall Implant Direct, INTERACTIVE HEALING COLLAR InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Iowa, Idaho, New Jersey, South Carolina and Virginia
- Medical device recall Safety-Deluxe Lumbar Puncture Tray BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Safety-Deluxe Lumbar Puncture Tray BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Laceration Tray BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lumbar Puncture Tray BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Safety Deluxe Bone Marrow Biopsy/Aspiration Tray BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only The design verification for the previous packaging configuration G928 does not cover the 70cm wires. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only The design verification for the previous packaging configuration G928 does not cover the 70cm wires. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length The design verification for the previous packaging configuration G928 does not cover the 70cm wires. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length The design verification for the previous packaging configuration G928 does not cover the 70cm wires. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length The design verification for the previous packaging configuration G928 does not cover the 70cm wires. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report32 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro… The low and high controls for the product are returning results above the assigned values. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall TD60 Transmitter battery charger used with the BeneVision Central Station A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report27 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Indiana, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, South Dakota, Texas, Utah, Washington and Wyoming
- Medical device recall VNS(R) Therapy Programmer, GMDN: 44077 Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereColorado and North Dakota
- Medical device recall Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1 The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2 The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1 The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2 The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1 The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2 The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Metrotom 800 Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusOngoingWhereArizona, California, Florida, Georgia, Illinois, North Carolina, New Jersey, Puerto Rico and Wisconsin
- Medical device recall SST TWIST DRILL, STANDARD, 1.6mm Dia One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm) Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal… Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU). Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in… Potentially mislabeled. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report15 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Maine, Minnesota, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Virginia and Wisconsin
- Medical device recall Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in… Potentially mislabeled. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report15 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Maine, Minnesota, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Virginia and Wisconsin
- Medical device recall 7x10” Small Utility Positioner with Cover Products may not meet specifications due to possible presence of metal shavings. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report17 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall 9x15” Medium Utility Positioner with Cover Products may not meet specifications due to possible presence of metal shavings. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report17 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall Triage Drugs of Abuse Plus TCA 25 Test Kit The recalled lots have demonstrated unexpected false positive THC results. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
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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