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 BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA universal and Endo GIA… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1)KIT4184 APEN LOBECTOMY KIT X0 Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and Endo GIA universal XL… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and Endo GIA universal XL… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) BOX LAPZD ZESTAW DO SG Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA universal and Endo GIA universal XL… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two,… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA universal and Endo GIA universal XL… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1)BOX PST04089 SLEEVE AIWA CLINIC Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA universal and Endo GIA universal XL… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1)BOX SLEEVEGK3 Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA universal and Endo GIA universal XL… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place… Device may be missing a sled component. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PHILIPS Xper Flex Cardio Physiomonitoring System The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RICHARD WOLF TUBE SET FOR TEM Tube ends may be mixed up. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and… A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Kelyniam Custom Skull Implant (CSI) Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kelyniam Custom Skull Implant (CSI) Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kelyniam Custom Skull Implant (CSI) Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kelyniam Custom Skull Implant (CSI) Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate There is an error in the caddy artwork that misidentifies a specific plate and screw. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereFlorida, Pennsylvania and Virginia
- Medical device recall Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw There is an error in the caddy artwork that misidentifies a specific plate and screw. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereFlorida, Pennsylvania and Virginia
- Medical device recall Nipro Blood Tubing set with Priming Set and Transducer Protectors There is a possibility of the heparin line is occluded. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereGeorgia, New York, Tennessee and Texas
- Medical device recall Trident Endoscopic Ultrasonic Biopsy Needle (FNB) The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportMichiganthe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Trident Endoscopic Ultrasonic Aspiration Needle (FNA) The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportMichiganthe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Fischer Cone Biopsy Excisor, Medium Products have been packaged with an incorrect product size. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereCalifornia, Maryland, Michigan, New Hampshire, New Jersey, Ohio, South Carolina and Wisconsin
- Medical device recall Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended… A failure of the tube arm suspension is possible while the tube arm height is being adjusted. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Maryland, Mississippi, New Jersey and New York
- Medical device recall Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended… A failure of the tube arm suspension is possible while the tube arm height is being adjusted. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Maryland, Mississippi, New Jersey and New York
- Medical device recall Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended… A failure of the tube arm suspension is possible while the tube arm height is being adjusted. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Maryland, Mississippi, New Jersey and New York
- Medical device recall Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs) The products are labeled with an incorrect product number. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNew York
- Medical device recall 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length,… Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length,… Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length,… Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length,… Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length,… Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Volcano CORE M2 Vascular System, Part # 400-0100.17 The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Maryland, North Carolina, Oregon and Tennessee
- Medical device recall Southmedic Sterile Disposable Scalpel Scalpels lot contains non-sterile products labeled as sterile. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereIowa, Illinois, Nebraska, New York and Texas
- Medical device recall iChem VELOCITY Urine Chemistry Strips A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACUSON SC2000 Ultrasound System The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia and Washington
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.”
Your shortlist0 of 4
Add one more to compare.