Endo Universal 65Recalls & reported problems across all models

We found 2 models of Endo Universal 65 by Covidien LP in the FDA's device registry (GUDID). Together they are named in 268 adverse event reports in the FDA's MAUDE database, received between Jul 30, 2017 and Sep 29, 2026 — classified as 10 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (161 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Endo Universal 65 problems

Endo Universal 65 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Endo Universal 65 173054

  Laparoscope, general & plastic surgery
  138 reports
• Endo Universal 65 173052

  Laparoscope, general & plastic surgery
  130 reports

Recent Endo Universal 65 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Misfire

  According to the reporter during a gastric bypass procedure, the powered Handle experienced a firing issue. The device was replaced to resolve the issue. No patient injury were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936682 ↗
• MalfunctionSep 21, 2026Misfire

  Patient problems: Insufficient Information

  MAUDE report 50848832 ↗
• MalfunctionSep 21, 2026Misfire; Failure to Fire; Firing Problem

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845085 ↗
• MalfunctionSep 21, 2026Misfire; Failure to Fire

  It was reported that during a gastric bypass, the device stops firing. Another same device with different lot number was used to resolve the issue.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840058 ↗
• MalfunctionSep 21, 2026Material Split, Cut or Torn; Firing Problem

  According to the reporter, intra-operatively, the stapler fired but became increasingly difficult to fire. The firing action grew heavier. The handle became harder and harder to squeeze. Additionally, the plastic was coming loose from the tip. Another device from another lot number was used to complete the case. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836276 ↗
• MalfunctionSep 17, 2026Failure to Fire; Insufficient Device Problem Information; Firing Problem

  According to the reporter, during a gastric bypass procedure, at the start of the procedure, the firing was not smooth then stopped. The device was replaced with the same model from a different lot number to complete the procedure. No patient injury was reported.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802560 ↗
• MalfunctionSep 16, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794730 ↗
• MalfunctionJun 19, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, STAPLING WAS NOT POSSIBLE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566627 ↗
• MalfunctionMay 4, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDLE NO LONGER CLOSED AFTER THE FIRST STAPLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073521 ↗
• MalfunctionMay 4, 2026Misfire; No Apparent Adverse Event; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE HANDLE NO LONGER CLOSES AFTER THE APPLICATION OF THE FIRST STAPLE. ANOTHER DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073518 ↗
• MalfunctionApr 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE BILATERAL INGUINAL HERNIA REPAIR, THE STAPLES DID NOT CLOSE AND THEREFORE DID NOT HOLD. FALLEN STAPLES FROM THE PATIENT CAVITY WERE RECOVERED ONE BY ONE WITH PLIERS, AND THE DURATION OF THE OPERATION WAS EXTENDED BY APPROXIMATELY 15 MINUTES. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018742 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REVIEW OF SECONDARY DATA SOURCES OF A STUDY ABOUT THE COMPLICATION OF INTERNAL HERNIATION ON INDEX IN 681 PATIENTS, WHICH ALL CAUSED READMISSIONS IN 118 PATIENTS AND ABDOMINAL HERNIA READMISSIONS IN TWO PATIENTS.

  Patient problems: Hernia

  MAUDE report 24956681 ↗
• MalfunctionMar 19, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE HERNIA STAPLER, THE STAPLES DID NOT CLOSE AND REMAINED OPEN WHICH LED TO EXTENDED SURGICAL TIME OF AROUND 30 MINUTES. THE DEVICE WAS REPLACED WITH ANOTHER STAPLER, AND THE AFFECTED AREA WAS RESECTED AND RE-STAPLED.

  Patient problems: Tissue Breakdown

  MAUDE report 24636484 ↗
• MalfunctionFeb 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS, AT THE LAST STEP WHEN CLOSING THE MESENTERY, SUDDENLY A PLASTIC PIECE WAS BROKE OFF AT THE TIP, OUTSIDE THE PATIENT, WHEN THE USER LOADED THE INSTRUMENT WITH MORE CLIPS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401421 ↗
• MalfunctionFeb 17, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE STAPLING THE MESH, THE STAPLER STOPPED FUNCTIONING AFTER SEVERAL USES AND COULD NO LONGER BE FIRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373617 ↗

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