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 Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional… There is the potential for the Rotating IV Pole to fall. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4 Affected lots may have exceeded its microbial limits. 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 Sofia 2 Analyzer The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first… 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 Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the… An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Norm-Ject Tuberkulin Syringe Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Indiana, Massachusetts, Nebraska, New Jersey, Ohio, Tennessee, Texas and Wisconsin named
- Medical device recall Echosight Jansen-Anderson Intratubal Transfer Set Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Indiana, Massachusetts, Nebraska, New Jersey, Ohio, Tennessee, Texas and Wisconsin named
- Medical device recall Marrs Laparoscopic GIFT Catheters Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Indiana, Massachusetts, Nebraska, New Jersey, Ohio, Tennessee, Texas and Wisconsin named
- Medical device recall 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia” Access… Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Indiana, Massachusetts, Nebraska, New Jersey, Ohio, Tennessee, Texas and Wisconsin named
- Medical device recall Tapered Screw-Vent MTX, Dental Implant, sterile Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tapered Screw-Vent MTX, Dental Implant, sterile Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit… Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Indiana, Maryland, Michigan, Minnesota, New Jersey, New York, Oregon, Puerto Rico and Washington
- Medical device recall Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit… Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Indiana, Maryland, Michigan, Minnesota, New Jersey, New York, Oregon, Puerto Rico and Washington
- Medical device recall Teleflex MEDICAL WECK Visistat 35 Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportKansasthe one state its words name PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereKansas
- Medical device recall ARROW ENDURANCE” Extended Dwell Peripheral Catheter System Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereColorado, Florida, Illinois, North Carolina, Pennsylvania, South Carolina and Texas
- Medical device recall Nucleic Acid test intended for screening for MRSA/SA The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. 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 AIM Tibial Nails intramedullary fixation rod - STERILE The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportIndianathe one state its words name PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereIndiana
- Medical device recall AIM Tibial Nails intramedullary fixation rod - NON-STERILE The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportIndianathe one state its words name PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereIndiana
- Medical device recall DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation… Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereArizona, Illinois, North Carolina, New Hampshire and Pennsylvania
- Medical device recall DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent. Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereArizona, Illinois, North Carolina, New Hampshire and Pennsylvania
- Medical device recall COACH¿ Self-Adhering Sports Wrap (size: 2in) Johnson & Johnson Consumer Inc. 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 COACH¿ Self-Adhering Sports Wrap (size: 3in) Johnson & Johnson Consumer Inc. 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 Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in) Johnson & Johnson Consumer Inc. 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 Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in) Johnson & Johnson Consumer Inc. 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 Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in) Johnson & Johnson Consumer Inc. 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 Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in) Johnson & Johnson Consumer Inc. 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 6F Taiga Guiding Catheter Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including… Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedApr 4, 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, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031 There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534 There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1 There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588 There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation… Stryker Instruments and Stryker Leibinger GmbH & Co. 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, 50-60 Hz Version is intended for use during diagnostic… The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked. 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, 50-60 Hz Version is intended for use during diagnostic… The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked. 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 (1) Sigma HP Cemented Trochlea Size 1 Narrow Left The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedApr 4, 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, 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 QUANTA-Lyser 240 IFA, Part #GS0242 The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument. 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 QUANTA-Lyser 240 EIA, Part #GS0241 The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument. 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 Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP,… Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port… 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¿ THE PERSONALIZED KNEE SYSTEM “PSN TIB STM 5 DEG SZ D R” indicated for patients with severe knee pain… A complaint was received for Item 42-5320-067-02, lot 63236047. 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 ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG 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 END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP… 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 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG… 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 LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable… 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 TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 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 180X11X140 STER TROC NAIL 125 DEG X 11MM 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
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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