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 ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST… Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X… Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE… Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE… Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL… Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and… Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Signia” Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia” Power Handle, when used with Endo… Product reportedly shutting down during use. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona Partial Knee spacer block instruments Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML One lot of humeral stem implants do not include the humeral bushing components. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD Broken or missing screws and retaining clips. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gas Module 3 monitoring spirometer The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification. Class IIIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedApr 4, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552;… Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641;… Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall 11g Verteport Cement Cannula Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex… Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Revolution CMS w/ Femoral Breakaway Nozzle & Med Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic… Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420,… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420,… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420,… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420,… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420,… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical… When the archiving configuration is changed, data received/created after the upgrade may be flagged as “Not to be archived”. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone… The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMRIS ORT100 Table The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IMRIS ORT200, Removable Operating Room Table The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IMRIS T2X Table The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IMRIS ORT300, Removable Operating Room Table The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall EasyCAL HbA1c Calibrator Patient results determined using this calibrator lot might deviate up to 20%. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, Puerto Rico and Texas
- Medical device recall c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use) Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter The kit was packaged with the incorrect guidewire. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas and California
- Medical device recall The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an… This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Minnesota, Oregon, Tennessee, Texas, Virginia and Washington named
- Medical device recall ProSpore Biological Indicator The concentration of bromocresol purple in the recalled lots does not conform to specification. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SporAmpule Biological Indicator The concentration of bromocresol purple in the recalled lots does not conform to specification. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37,… Software issue with Center Beam in Field functionality. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Iridex TruFocus LIO Premiere” Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect… It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GENICON EZEE Retrieval, sterile Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereFlorida, Illinois, Michigan, Tennessee and Utah
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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