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 Auriga XL 4007 Laser System, Universal Certain Auriga consoles have incorrectly assembled trigger wire components. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile Sterile pouches are missing labels on them. Class IIIFDA’s classMar 14, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 14, 2018ClassClass IIIStatusTerminatedWherePuerto Rico
- Medical device recall BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a… Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile Possible lack of product sterility due to potential gaps/channeling in the seal of the package. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 14, 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 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile Possible lack of product sterility due to potential gaps/channeling in the seal of the package. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 14, 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 2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile Possible lack of product sterility due to potential gaps/channeling in the seal of the package. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 14, 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 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile Possible lack of product sterility due to potential gaps/channeling in the seal of the package. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 14, 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 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile Possible lack of product sterility due to potential gaps/channeling in the seal of the package. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 14, 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 2.5 mm Titanium Calibrated Reaming Rod, 850 mm Possible lack of product sterility due to potential gaps/channeling in the seal of the package. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 14, 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 Light Clip for Oracle Retractor, sterile Possible lack of product sterility due to potential gaps/channeling in the seal of the package. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 14, 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 Endo GIA” Radial Reload with Tri-Staple” Technology The Endo GIA radial reloads with Tri-Staple Technology… The device cartridge disengaged during use due to manufacturing error. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall cobas 6000 Modular Series system A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 14, 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, 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 cobas 8000 Modular Analyzer Series A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMar 14, 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, 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 VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Minnesota, Missouri, Ohio, Pennsylvania, Texas, Vermont and Washington named
- Medical device recall Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Minnesota, Missouri, Ohio, Pennsylvania, Texas, Vermont and Washington named
- Medical device recall Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and… The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement Report32 statesnamed in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder… The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement Report32 statesnamed in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Signature Ceramic Femoral Head This recall has been identified due to the batch being mislabeled, with the packaged component’s size not corresponding to the label. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000,… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000,… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry… There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000,… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease. Internal program testing shows that product may not reach the indicated expiration date. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 14, 2018ClassClass IIStatusOngoingWhereDistrict of Columbia and Florida
- Medical device recall QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts,… A customer complained that one of the pouches in a box of 10 had “QuikClot Roll” pouch instead of “QuikClot TraumaPad” pouch. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200… Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges,… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement Report49 statesnamed in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall O-arm¿ O2 interventional fluoroscopic x-ray system During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall O-arm 1000 mobile image-intensified fluoroscopic x-ray system Software update (“SW Update 3.2.1”) is being implemented to address the following issues: Inability to power the system after shutdown, System stays in… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proteus 235, graphite block 8 IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names:… Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall 241-McKesson Premium Skin Staple Remover Kit Product not meeting the iodine assay level requirements to support 36 month expiration dating. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereColorado, Florida, Georgia, Kentucky, Michigan, Missouri, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact… The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. Class IIIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare… The mounts on the monitor may have an insufficient (missing or incomplete) weld. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coated VICRYL RAPIDETM (Polyglactin 910) Suture On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System A faulty footswitch may result in unintended ultrasonic fragmentation activation. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation… Leakage of FMS gravity tub sets (281113) at the bulb and tube connection Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A20975A “Working insert, with ramp, one way” (Lots 13ZW to 172W Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOOG Curlin Infusion Administration Set Particulate found on the Curlin spike. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOOG Curlin Infusion Administration Set Particulate found on the Curlin spike. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOOG Curlin Infusion Administration Set Particulate found on the Curlin spike. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOOG Curlin Infusion Administration Set Particulate found on the Curlin spike. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOOG Curlin Infusion Administration Set Particulate found on the Curlin spike. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOOG Curlin Infusion Administration Set Particulate found on the Curlin spike. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical… The foot control used on the OAKWORKS¿ Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 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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