ECHLEON ECH60RRecalls & reported problems

Summary

The FDA's MAUDE database contains 313 adverse event reports that list this exact device (DI 10705036023296), received between Sep 14, 2020 and Sep 30, 2026 — classified as 74 injuries, 239 malfunctions.

The most frequently reported specific device problem is “Ambient Temperature Problem” (182 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 313 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Ambient Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951770 ↗
• MalfunctionSep 30, 2026Ambient Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948524 ↗
• MalfunctionSep 30, 2026Ambient Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948523 ↗
• MalfunctionSep 30, 2026Ambient Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948521 ↗
• MalfunctionSep 30, 2026Ambient Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948519 ↗
• MalfunctionAug 20, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50352181 ↗
• MalfunctionAug 3, 2026Ambient Temperature Problem

  It was reported by the distributor that during their incoming inspection, they found the temperature indicator on the inner packaging small box has turned red abnormally. There was no patient involvement reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122652 ↗
• MalfunctionJul 9, 2026Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT DURING ATTACHMENT IN LAPAROSCOPIC THORACIC SURGERY, THE STAPLE LINE REINFORCEMENT WAS BROKEN AND COULD NOT BE PROPERLY ADHERED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769210 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE PERFORMED WELL DURING THE PROCEDURE. THE PATIENT SUFFERED A LEAK. THE CUSTOMER HAS MADE IT CLEAR THAT THIS COULD BE A STATISTICAL ANOMALY AND THE LEAK IS OF COURSE MULTIFACTORIAL, BUT THEY CANNOT IGNORE THE FACT THAT THE ONLY DIFFERENCE IN THEIR SURGICAL APPROACH HAS BEEN THE ADDITION OF SLR.

  Patient problems: Failure to Anastomose

  MAUDE report 25578453 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE PERFORMED WELL DURING THE PROCEDURE. THE PATIENT SUFFERED A LEAK. THE CUSTOMER HAS MADE IT CLEAR THAT THIS COULD BE A STATISTICAL ANOMALY AND THE LEAK IS OF COURSE MULTIFACTORIAL, BUT THEY CANNOT IGNORE THE FACT THAT THE ONLY DIFFERENCE IN THEIR SURGICAL APPROACH HAS BEEN THE ADDITION OF SLR.

  Patient problems: Failure to Anastomose

  MAUDE report 25578432 ↗
• MalfunctionMay 7, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114268 ↗
• MalfunctionMay 7, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114266 ↗
• MalfunctionApr 27, 2026Ambient Temperature Problem

  IT WAS REPORTED THAT THE TEMPERATURE INDICATOR ON THE FRONT OF THE TWO BOXES WERE OBSERVED TO BE RED, WHEREAS THEY SHOULD HAVE BEEN CLEAR. THE TWO BOXES WERE DELIVERED AND HAD NOT BEEN OPENED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25005149 ↗
• MalfunctionApr 27, 2026Ambient Temperature Problem

  IT WAS REPORTED THAT THE TEMPERATURE INDICATOR ON THE FRONT OF THE TWO BOXES WERE OBSERVED TO BE RED, WHEREAS THEY SHOULD HAVE BEEN CLEAR. THE TWO BOXES WERE DELIVERED AND HAD NOT BEEN OPENED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25005147 ↗
• MalfunctionApr 3, 2026Ambient Temperature Problem

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT THE DISTRIBUTOR: (B)(4), THEY FOUND THE TEMPERATURE INDICATOR ON THE OUTER CARTON HAD TURNED RED, AND AMONG THE SIX INNER BOXES, ONE BOX HAD ALSO TURNED RED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780290 ↗
• MalfunctionJan 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IT WAS OBSERVED THAT THE STAPLE LINE REINFORCEMENT ON THE ANVIL SIDE WAS PEELED OFF. THE CARTRIDGE COLOR WAS BLUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960669 ↗
• MalfunctionDec 25, 2025Ambient Temperature Problem; Ambient Temperature Problem

  IT WAS REPORTED THAT THE RED INDICATOR ON THE BOXES HAD TURNED RED. THE BOXES WERE UNOPENED AND WAS STORED AT ROOM TEMPERATURE IN ETHICON STAPLE CARTS. IT WAS UNKNOWN WHY IT TURNED RED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892498 ↗
• MalfunctionDec 25, 2025Ambient Temperature Problem; Ambient Temperature Problem

  IT WAS REPORTED THAT THE RED INDICATOR ON THE BOXES HAD TURNED RED. THE BOXES WERE UNOPENED AND WAS STORED AT ROOM TEMPERATURE IN ETHICON STAPLE CARTS. IT WAS UNKNOWN WHY IT TURNED RED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892497 ↗
• MalfunctionDec 25, 2025Ambient Temperature Problem; Ambient Temperature Problem

  IT WAS REPORTED THAT THE RED INDICATOR ON THE BOXES HAD TURNED RED. THE BOXES WERE UNOPENED AND WAS STORED AT ROOM TEMPERATURE IN ETHICON STAPLE CARTS. IT WAS UNKNOWN WHY IT TURNED RED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892496 ↗
• MalfunctionDec 25, 2025Ambient Temperature Problem; Ambient Temperature Problem

  IT WAS REPORTED THAT THE RED INDICATOR ON THE BOXES HAD TURNED RED. THE BOXES WERE UNOPENED AND WAS STORED AT ROOM TEMPERATURE IN ETHICON STAPLE CARTS. IT WAS UNKNOWN WHY IT TURNED RED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892493 ↗
• MalfunctionDec 25, 2025Ambient Temperature Problem; Ambient Temperature Problem

  IT WAS REPORTED THAT THE RED INDICATOR ON THE BOXES HAD TURNED RED. THE BOXES WERE UNOPENED AND WAS STORED AT ROOM TEMPERATURE IN ETHICON STAPLE CARTS. IT WAS UNKNOWN WHY IT TURNED RED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892492 ↗
• MalfunctionDec 25, 2025Ambient Temperature Problem; Ambient Temperature Problem

  IT WAS REPORTED THAT THE RED INDICATOR ON THE BOXES HAD TURNED RED. THE BOXES WERE UNOPENED AND WAS STORED AT ROOM TEMPERATURE IN ETHICON STAPLE CARTS. IT WAS UNKNOWN WHY IT TURNED RED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892490 ↗
• MalfunctionDec 25, 2025Ambient Temperature Problem; Ambient Temperature Problem

  IT WAS REPORTED THAT THE RED INDICATOR ON THE BOXES HAD TURNED RED. THE BOXES WERE UNOPENED AND WAS STORED AT ROOM TEMPERATURE IN ETHICON STAPLE CARTS. IT WAS UNKNOWN WHY IT TURNED RED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892487 ↗
• MalfunctionDec 25, 2025Ambient Temperature Problem; Ambient Temperature Problem

  IT WAS REPORTED THAT THE RED INDICATOR ON THE BOXES HAD TURNED RED. THE BOXES WERE UNOPENED AND WAS STORED AT ROOM TEMPERATURE IN ETHICON STAPLE CARTS. IT WAS UNKNOWN WHY IT TURNED RED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892485 ↗
• MalfunctionDec 25, 2025Ambient Temperature Problem; Ambient Temperature Problem

  IT WAS REPORTED THAT THE RED INDICATOR ON THE BOXES HAD TURNED RED. THE BOXES WERE UNOPENED AND WAS STORED AT ROOM TEMPERATURE IN ETHICON STAPLE CARTS. IT WAS UNKNOWN WHY IT TURNED RED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892484 ↗