AESCULAP US906Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05055049007423), received between Oct 1, 2020 and May 19, 2022 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Unexpected Color” (26 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14439369 ↗
• MalfunctionMay 11, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14365952 ↗
• MalfunctionApr 29, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253177 ↗
• MalfunctionApr 29, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253155 ↗
• MalfunctionApr 8, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT TRANSITIONED TO ITS POST STERILIZATION COLOR, HOWEVER, THE INDICATOR DOT TURNED BACK TO BLUE AFTER APPROXIMATELY THRITY (30) TO SIXTY (60) DAYS WHILE IN STORAGE IN THE STERILE PROCESSING DEPARTMENT (SPD). THE LOCK WAS NOT IN EXTREME TEMPERATURES WHILE IN STERILE STORAGE WITHIN THE DEPARTMENT. THE CONTAINERS ARE STORED ON NORMAL SHELVING AND ARE NOT EXPOSED TO INTENSE LIGHT. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053537 ↗
• MalfunctionMar 30, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE INDICATOR DOT FAILED TO FULLY TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956208 ↗
• MalfunctionMar 2, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656095 ↗
• MalfunctionMar 2, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656083 ↗
• MalfunctionMar 2, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656058 ↗
• MalfunctionFeb 10, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509092 ↗
• MalfunctionFeb 8, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13486823 ↗
• MalfunctionJan 12, 2022Device Ingredient or Reagent Problem; Unexpected Color; Device Ingredient or Reagent Problem; Unexpected Color

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN ORANGE STEAM INDICATOR. THE INDICATOR ON THE LOCK DID NOT TURN OR ONLY SLIGHTLY TURNED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236643 ↗
• MalfunctionJan 12, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236006 ↗
• MalfunctionDec 29, 2021Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13113138 ↗
• MalfunctionDec 10, 2021Device Ingredient or Reagent Problem; Unexpected Color; Device Ingredient or Reagent Problem; Unexpected Color

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN ORANGE INDICATOR. THE TAG WAS "FAULTY" AND FAILED THE STERILIZATION CYCLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975566 ↗
• MalfunctionDec 8, 2021Material Integrity Problem; Unexpected Color; Material Integrity Problem; Unexpected Color

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A STEAM STER LOCKS ORANGE. IT WAS NOTED THAT THE ORANGE LOCKS DOES NOT CHANGE COLOR WHEN GOING THROUGH STERILIZATION. BLUE DOES NOT CHANGE TO BROWN. ADDITIONAL INFORMATION WAS NOT PROVIDED. ASSOCIATED MEDWATCH-REPORTS: 2916714-2021-00230 ((B)(4) - US906).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962096 ↗
• MalfunctionDec 8, 2021Material Integrity Problem; Unexpected Color; Material Integrity Problem; Unexpected Color

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A STEAM STER LOCKS ORANGE. IT WAS NOTED THAT THE ORANGE LOCKS DOES NOT CHANGE COLOR WHEN GOING THROUGH STERILIZATION. BLUE DOES NOT CHANGE TO BROWN. ADDITIONAL INFORMATION WAS NOT PROVIDED. ASSOCIATED MEDWATCH-REPORTS: 2916714-2021-00231 ((B)(4) - US906).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962049 ↗
• MalfunctionNov 16, 2021Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821687 ↗
• MalfunctionNov 16, 2021Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT FAILED TO CONSISTENTLY TRANSITION TO ITS POST STERILIZATION COLOR. REPORTEDLY, ONE SIDE OF THE LOCK WOULD CHANGE COLOR, BUT THE BLUE MARK ON THE OTHER SIDE WOULD NOT COMPLETELY TRANSITION. COLOR WOULD NOT EVEN PARTIALLY CHANGE FROM BLUE TO BLACK. THE SET WAS PULLED, THE LOCK WAS CHANGED, AND THE INSTRUMENTS WERE RE-STERILIZED. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821537 ↗
• MalfunctionNov 4, 2021Defective Component; Unexpected Color; Defective Component; Unexpected Color

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN ORANGE INDICATOR DOT. THE TAMPER-EVIDENT LOCK WITH INDICATOR DOT DID NOT CHANGE COLOR AFTER PROCESSING. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751448 ↗
• MalfunctionOct 27, 2021Defective Component; Unexpected Color; Defective Component; Unexpected Color

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN ORANGE INDICATOR DOT. THE TAMPER-EVIDENT LOCK WITH INDICATOR DOT DID NOT CHANGE COLOR AFTER PROCESSING AND WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703992 ↗
• MalfunctionSep 22, 2021Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT FAILED TO CONSISTENTLY TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12515163 ↗
• MalfunctionAug 25, 2021Unexpected Color; Unexpected Color

  IT WAS REPORTED TO AESCULAP INC. THAT A STEAM STER LOCKS ORANGE (PART # US906) WAS USED TO SECURE A STERILIZATION CONTAINER. ACCORDING TO THE COMPLAINANT, THE INDICATOR DOT FAILED TO TRANSITION TO ITS POST STERILIZATION COLOR. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366726 ↗
• MalfunctionAug 25, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH ORANGE INDICATOR DOT. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BLUE DOT ON THE ORANGE LOCK CHANGED FROM BLUE TO BROWN AS EXPECTED DURING STERILIZATION. SOMETIME LATER THE INDICATOR DOT CHANGED TO WHITE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365509 ↗
• MalfunctionAug 5, 2021Defective Component; Unexpected Color; Defective Component; Unexpected Color

  IT WAS REPORTED THAT THERE WAS AN ISSUE AN ORANGE INDICATOR DOT. THE TAMPER-EVIDENT LOCK WITH INDICATOR DOT DID NOT CHANGE COLOR AFTER PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280692 ↗