Tri-Staple 2.0 SIG45AXTRecalls & reported problems
Covidien LP · Black Intelligent Reload · Class 2 · Implant
Quick summary
This Covidien Tri-Staple 2.0 surgical stapler has 341 adverse event reports on file, with no deaths and 24 injuries. Many reports describe the stapler failing to fire, handles or parts cracking or breaking, and staples not forming properly. No recalls name this device. Reports in the last 12 months fell to 19 from 44 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 342
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 10884521543607), received between Aug 11, 2017 and Sep 29, 2026 — classified as 24 injuries, 318 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (152 reports).
14 other recalls cover devices cleared under the same FDA submission (K160176); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Fire152
- Misfire67
- Failure to Form Staple48
- Break40
- Entrapment of Device29
- Difficult to Open or Close28
- Insufficient Device Problem Information26
- Device Displays Incorrect Message18
Patient problems
- No Clinical Signs, Symptoms or Conditions182
- No Consequences Or Impact To Patient69
- Insufficient Information31
- Tissue Breakdown31
- Unspecified Tissue Injury20
- No Known Impact Or Consequence To Patient15
- No Code Available6
- No Information4
Recent adverse event reports
The 25 most recent of 342 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Cut
It was reported that during the video-assisted thoracoscopic surgery, two reloads stapled but did not cut at all. The procedure time was extended by 10 minutes. The device was replaced, and a new reload was purchased to resolve the issue.
Patient problems: Tissue Breakdown
MAUDE report 50934872 ↗MalfunctionSep 21, 2026Break; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844746 ↗MalfunctionAug 25, 2026Failure to Fire
According to the reporter, during a thoracoscopic lung malignant tumor surgery (partial resection), the green button did not function and could not be pressed, preventing stapling from being performed. A new handle and reload were used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435334 ↗MalfunctionApr 24, 2026Misfire; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN THORACOTOMY LUNG RESECTION, DURING THE TRANSECTION OF THE LUNG, FOUR HANDLES BROKE. THE HANDLES ALL CRACKED DURING FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DEVICE PARTIALLY FIRED.
Patient problems: Insufficient Information
MAUDE report 24985291 ↗MalfunctionApr 1, 2026Break; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN USING THE POWERED STAPLER ON THE THICK PARENCHYMA, THE CHARGER WAS AT MAXIMUM ANGLE. IT WAS IMPOSSIBLE TO RETURN TO THE UPRIGHT POSITION AND IMPOSSIBLE TO REMOVE THE CHARGER. THE STANDARD ADAPTER AND THE CHARGER WERE COMPLETELY JAMMED. IT WAS NOTED THAT THE ARTICULATION JOINT WAS BROKEN. THE ADAPTER AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756119 ↗MalfunctionMar 30, 2026Failure to Fire; Expulsion
ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PARTIAL RESECTION OF THE RIGHT UPPER LOBE, AT THE TIME OF THE THIRD FIRING OF THE PARTIAL RESECTION, THE FIRING COULD NOT BE DONE AT ALL. IT WAS NOTED THAT THE USER WAS ABLE TO PRESS THE GREEN BUTTON AND THE JAW WAS COMPLETELY CLOSED. THE STAPLE CAME OUT AROUND THE PROXIMAL SIDE OF THE CARTRIDGE JAW. A NEW RELOAD AND THE SAME HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24721237 ↗MalfunctionMar 12, 2026Failure to Form Staple
ACCORDING TO THE REPORTER, DURING LEFT LUNG S6 SEGMENTECTOMY, PULMONARY PARENCHYMA RESECTION, THERE WERE SOME AREAS WHERE THE STAPLES HAD NOT BEEN FORMED (THIS U-SHAPED STAPLE IS VISIBLE, BUT NOT YET FORMED). SPECIFICALLY, OF THE 45MM LENGTH OF SUTURE, THE FRONT THIRD (TOWARDS THE BASE OF THE JAW) AND THE TIP THIRD WERE NOT STAPLED PROPERLY, WITH ONLY THE MIDDLE PART STAPLED. THE BRONCHIAL STUMP HAD BEEN CLAMPED IN THE MIDDLE, LEAVING ONLY THE MIDDLE THICK, WHILE THE FRONT AND BACK WERE JUST THIN LUNG PARENCHYMA THE STAPLE COULD NOT BE FIRED COMPLETELY.
Patient problems: Tissue Breakdown
MAUDE report 24584401 ↗MalfunctionMar 3, 2026Break; Misfire; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 6 CM TUMOR, THREE HANDLES AND ONE RELOAD WERE DIFFICULT TO FIRE, RESULTING IN AN EXTENDED SURGICAL TIME. THE SURGEON USED MULTIPLE CARTRIDGES BECAUSE THE DEVICE COULD NOT BE FULLY ACTIVATED. WHEN THE CARTRIDGE WAS CLOSED ON THE LUNG, THE ANVIL BOUNCED BACK. IT WAS NOTED THAT THE HANDLE WAS CRACKING. THE DEVICE WAS REPLACED TWICE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE RELOADS WERE PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. STAPLE PUSHERS WERE VISIBLE AT VARIOUS POINTS BETWEEN THE 2 AND 3CM CUT LINES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501014 ↗MalfunctionMar 3, 2026Break; Misfire; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 6 CM TUMOR, THREE HANDLES AND ONE RELOAD WERE DIFFICULT TO FIRE, RESULTING IN AN EXTENDED SURGICAL TIME. THE SURGEON USED MULTIPLE CARTRIDGES BECAUSE THE DEVICE COULD NOT BE FULLY ACTIVATED. WHEN THE CARTRIDGE WAS CLOSED ON THE LUNG, THE ANVIL BOUNCED BACK. IT WAS NOTED THAT THE HANDLE WAS CRACKING. THE DEVICE WAS REPLACED TWICE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE RELOADS WERE PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. STAPLE PUSHERS WERE VISIBLE AT VARIOUS POINTS BETWEEN THE 2 AND 3 CM CUT LINES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500856 ↗MalfunctionFeb 26, 2026Misfire; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 6 CM TUMOR, THREE HANDLES AND ONE RELOAD WERE DIFFICULT TO FIRE, RESULTING IN AN EXTENDED SURGICAL TIME. THE SURGEON USED MULTIPLE CARTRIDGES BECAUSE THE DEVICE COULD NOT BE FULLY ACTIVATED. WHEN THE CARTRIDGE WAS CLOSED ON THE LUNG, THE ANVIL BOUNCED BACK. IT WAS NOTED THAT THE HANDLE WAS CRACKING. THE DEVICE WAS REPLACED TWICE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE RELOADS WERE PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. STAPLE PUSHERS WERE VISIBLE AT VARIOUS POINTS BETWEEN THE 2 AND 3CM CUT LINES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454416 ↗MalfunctionFeb 23, 2026Difficult to Open or Close
ACCORDING TO THE REPORTER, IN A PNEUMONECTOMY, WHILE IN THE BRONCHUS, THE JAW DID NOT CLOSE COMPLETELY, SO THE GREEN LAMP WOULD NOT LIGHT UP. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24416301 ↗MalfunctionFeb 20, 2026Difficult to Open or Close
ACCORDING TO THE REPORTER, PREOPERATIVELY, DURING SET UP, THE RELOAD WAS CONNECTED TO THE MANUAL STAPLER, AN ATTEMPT TO CHECK THE OPENING AND CLOSING WAS DONE BUT THERE WAS NO RESPONSE, SO A NEW CARTRIDGE WAS TAKEN OUT, AND ATTEMPTED TO CHECK THE OPENING AND CLOSING, BUT A SNAPPING SOUND WAS HEARD, AND IT COULD NOT BE OPENED OR CLOSED. THE DEVICE WAS CHANGED TO A POWER STAPLER, AND WHEN THE NEW CARTRIDGE WAS USED, THE FIRING WAS PERFORMED WITHOUT ANY PROBLEMS. IT WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408337 ↗MalfunctionFeb 20, 2026Difficult to Open or Close
ACCORDING TO THE REPORTER, PREOPERATIVELY, DURING SET UP, THE RELOAD WAS CONNECTED TO THE MANUAL STAPLER, AN ATTEMPT TO CHECK THE OPENING AND CLOSING WAS DONE BUT THERE WAS NO RESPONSE, SO A NEW CARTRIDGE WAS TAKEN OUT, AND ATTEMPTED TO CHECK THE OPENING AND CLOSING, BUT A SNAPPING SOUND WAS HEARD, AND IT COULD NOT BE OPENED OR CLOSED. THE DEVICE WAS CHANGED TO A POWER STAPLER, AND WHEN THE NEW CARTRIDGE WAS USED, THE FIRING WAS PERFORMED WITHOUT ANY PROBLEMS. IT WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408328 ↗MalfunctionJan 29, 2026Misfire; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING THE LOBECTOMY, WHILE FIRING VASCULAR LOADS, STAPLING PROCEEDED WITHOUT ANY ISSUES AND WAS CONSIDERED SAFE. HOWEVER, WHEN THE SURGEON SWITCHED TO A BLACK RELOAD FOR THE BRONCHUS, THE RELOAD INITIATED THE FIRING SEQUENCE BUT STOPPED ALMOST IMMEDIATELY, RELEASING OPEN STAPLES BUT DID NOT STAPLE THE TISSUE, AND THE KNIFE DID NOT ADVANCE. AFTERWARDS, THE SURGEON OPENED A MANUAL STAPLER AND FIRED ANOTHER BLACK RELOAD FROM THE SAME BATCH WITHOUT ANY ISSUES. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD HAS PUSHERS DEPLOYED UP TO 3CM CUT LINE. THE RELOAD HAD PARTIALLY DEPLOYED STAPLES DISTAL TO THE EXPOSED PUSHERS.
Patient problems: Insufficient Information
MAUDE report 24215559 ↗MalfunctionJan 28, 2026Misfire
ACCORDING TO THE REPORTER, IN A VIDEO-ASSISTED THORACIC SURGERY (VATS) PROCEDURE, WHILE IN THE LUNG, THE POWERED STAPLER PARTIALLY FIRED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206287 ↗MalfunctionJan 9, 2026Misfire; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE INSTRUMENT MADE STRANGE NOISE. THE DISTAL STAPLE LINE WAS INCOMPLETE. THE STAPLER CUT BUT DID NOT DEPLOY THE STAPLES AND SOME OF THE DEPLOYED STAPLES DID NOT FORM PROPERLY. THE STAPLE LINE BLED. THERE WAS BLOOD LOSS OF 500CC OR MORE. THE STAPLE LINE WAS RESECTED AND RE-STAPLED TO FIX THE ISSUE. THE ISSUE RESULTED TO THE PROCEDURE CHANGING TO A LUNG LOBECTOMY INSTEAD OF SEGMENT RESECTION. THE SURGICAL TIME WAS EXTENDED FOR 20 MINUTES. MEDTRONIC¿S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT STAPLE PUSHERS WERE VISIBLE AT THE 2CM CUT LINE.
Patient problems: Insufficient Information
MAUDE report 24024233 ↗MalfunctionJan 2, 2026Difficult to Remove; Misfire; Firing Problem
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 6 CM TUMOR, THREE HANDLES AND ONE RELOAD WERE DIFFICULT TO FIRE, RESULTING IN AN EXTENDED SURGICAL TIME. THE SURGEON USED MULTIPLE CARTRIDGES BECAUSE THE DEVICE COULD NOT BE FULLY ACTIVATED. WHEN THE CARTRIDGE WAS CLOSED ON THE LUNG, THE ANVIL BOUNCED BACK. IT WAS NOTED THAT THE HANDLE WAS CRACKING. THE DEVICE WAS REPLACED TWICE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943647 ↗MalfunctionDec 18, 2025Misfire; Misfire
ACCORDING TO THE REPORTER, DURING THE LOBECTOMY, WHILE FIRING VASCULAR LOADS, STAPLING PROCEEDED WITHOUT ANY ISSUES AND WAS CONSIDERED SAFE. HOWEVER, WHEN THE SURGEON SWITCHED TO A BLACK RELOAD FOR THE BRONCHUS, THE RELOAD INITIATED THE FIRING SEQUENCE BUT STOPPED ALMOST IMMEDIATELY, RELEASING OPEN STAPLES BUT DID NOT STAPLE THE TISSUE, AND THE KNIFE DID NOT ADVANCE. AFTERWARDS, THE SURGEON OPENED A MANUAL STAPLER AND FIRED ANOTHER BLACK RELOAD FROM THE SAME BATCH WITHOUT ANY ISSUES.
Patient problems: Insufficient Information
MAUDE report 23846389 ↗MalfunctionDec 11, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A RIGHT VATS (VIDEO-ASSISTED THORACIC SURGERY) WEDGE RESECTION OF THE LOWER AND MIDDLE LOBES, THE FIRST RELOAD EXPERIENCED INCOMPLETE DEPLOYMENT OF STAPLES DURING THE FINAL FIRING ACROSS LUNG TISSUE CONTAINING A PULMONARY ARTERY BRANCH, RESULTING IN ONLY A FEW VISIBLE COMPLETED STAPLES AT THE APEX, WITH THE REMAINING STAPLES EITHER NOT FOUND OR BUNCHED AT THE DISTAL END AND NOT COMPLETELY FORMED. THIS LED TO BLEEDING FROM A PULMONARY ARTERY BRANCH, REQUIRING THE IMMEDIATE CLOSURE OF JAWS TO APPLY PRESSURE TO THE TISSUE AND VESSEL, CALLING BLOOD INTO THE ROOM, OPENING ALL THORACOTOMY TRAYS IN PREPARATION FOR POSSIBLE CONVERSION TO OPEN SURGERY, AND BRINGING IN A SECOND STAPLER SETUP. THE PROCEDURE WAS EXTENDED BY 30 MINUTES. THE TEAM WAS ABLE TO CLAMP OFF THE SECTION AND FIRE ANOTHER RELOAD TO COMPLETE THE WEDGE RESECTION WITHOUT ADDITIONAL ISSUE. THE SECOND RELOAD WHEN FIRED ACROSS THE PARENCHYMA, EXPERIENCED A BREAK AT THE ARTICULATION JOINT, WITH THE BROKEN PART DISENGAGING BUT NOT FALLING INTO THE PATIENT CAVITY, AND THE BLOWOUT PLATE WAS EXPOSED AND RIBBONED OUT AT THE WRIST JOINT DURING RETRACTION OF THE KNIFE BLADE WHILE IN A FULLY ARTICULATED POSI
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 23782460 ↗MalfunctionDec 4, 2025Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE FIRING COULD NOT BE DONE AT ALL. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715776 ↗MalfunctionOct 16, 2025Misfire; Failure to Fire; Misfire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A SURGICAL PROCEDURE INVOLVING RECTAL RESECTION, THE FIRING COULD NOT BE DONE AT ALL. THE ISSUE WAS RESOLVED BY REPLACING THE HANDLE AND RELOAD. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT RELOAD WAS PRE-FIRED AND THE INTERLOCK WAS ENGAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310674 ↗MalfunctionOct 15, 2025Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING THE UNIPORTAL VIDEO ASSISTED THORACOSCOPIC SURGERY, WHEN APPLIED ON THE BRONCHUS, THE FIRING WAS P ERFORMED IN SLOW MODE, AND THE FIRING PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS BUT UNFORMED/INCOMPLETE STAPLE WAS OBSERVED IN THE PART OF THE STAPLE LINE (PART OF THE THIRD ROW ON THE JAW SIDE). THE UNFORMED/INCOMPLETE STAPLE WAS LEFT AS IT WAS AND THE PROCEDURE WAS COMPLETED WITHOUT INTERVENTION.
Patient problems: Tissue Breakdown
MAUDE report 23303217 ↗MalfunctionSep 19, 2025Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LOBECTOMY, WHEN THE CARTRIDGE WAS LOADED INTO THE MANUAL STAPLER, THE JAWS WERE INSERTED INTO THE PULMONARY PARENCHYMA, THE HANDLE WAS SQUEEZED, AND THE JAWS WERE CLOSED. THE GREEN BUTTON WAS PRESSED, AND THE HANDLE WAS TRIED TO SQUEEZE, BUT IT WAS OBSERVED THAT THE HANDLE WAS STIFF/HARD, AND IT COULD NOT BE SQUEEZED. A NEW HANDLE AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23092727 ↗MalfunctionSep 9, 2025Failure to Fire; Expulsion; Failure to Fire; Expulsion
ACCORDING TO THE REPORTER, DURING A PARTIAL LUNG RESECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE HANDLE COULD NOT BE SQUEEZED. HENCE, THE FIRING COULD NOT BE DONE AT ALL. IT WAS NOTED THAT THE STAPLE APPEARED NEAR THE BASE OF THE JAW OF THE CARTRIDGE. A NEW HANDLE AND CARTRIDGE WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003772 ↗MalfunctionAug 28, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE THORACIC PROCEDURE; THE INSTRUMENT DID NOT FIRE FOR THE TWO RELOADS. THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON BUT WAS NOT ABLE TO SQUEEZE THE HANDLE. ANOTHER CARTRIDGE WAS OPENED, AND THE SAME HANDLE WAS USED TO CONTINUE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22917181 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K160176. One submission often covers many models, so check the product and lot details in each record.
- Z-1228-2023 · Jan 25, 2023 · Open, ClassifiedTri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- Z-1833-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Z-1834-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
- Z-1826-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- Z-1830-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- Z-1831-2019 · May 17, 2019 · Open, ClassifiedEGIA45 CT AR MD THK REL, EGIA45CTAMT
- Z-1832-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
- Z-1836-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
- Z-1825-2019 · May 17, 2019 · Open, ClassifiedEGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- Z-1835-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
- Z-1827-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- Z-1829-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
- Z-1828-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
- Z-1237-2018 · Dec 13, 2017 · TerminatedSignia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Sta
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.