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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall PROLENE SUTURE 30”(75CM) 6-0 BLUE, D8647 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 24”(60CM) 6-0 BLUE, D8688 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 24”(60CM) 7-0 BLUE, D8881 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 36”(90CM) 4-0 BLUE, D9067 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 4”(10CM) 8-0 BLUE, D9662 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE BLUE 48” 4-0 D/A SH-1, D9746 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE 36”(90CM) 3-0 BLU, D9844 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PROLENE SUTURE BLUE 18” 7-0 D/A BV-1, DC631 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PRONOVA SUTURE BLUE 122CM M1.5, D10189 The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered… A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Fx SOLUTIONS CENTERED HEAD CoCr 50x19 Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fx SOLUTIONS OFFSET HEAD CoCr 50x20 Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proteus 235, Universal Nozzle with snout 300x400 Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722,… The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report23 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kentucky, Maryland, Minnesota, Mississippi, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia and Wisconsin
- Medical device recall Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the… The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Presource PBDS, Kit, Common Diabetes A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Presource PBDS, Kit, Common A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Presource PBDS, Kit, No Spiro A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Presource PBDS, Kit, No Spiro Diabetes A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH) Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Louisiana, Massachusetts, Maryland, Montana, North Carolina, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe,… The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe,… The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike The suction valve may not close properly which could cause continuous suction. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wyoming
- Medical device recall Ingenuity Digital PET/CT System The block used to connect the patient pallet to the couch may be assembled incorrectly. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Georgia, Louisiana, Maryland, Michigan, New York, Ohio, Tennessee, Texas, Vermont and Wisconsin named
- Medical device recall RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9… If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Visualase Cooled Laser Applicator System (VCLAS) labeled as: a Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Kansas, Kentucky, Louisiana, Maryland, Maine, Missouri, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Utah and Washington named
- Medical device recall Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
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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