ACS CDEX31DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00191072046109), received between Jan 24, 2019 and Mar 27, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2020Device Contamination with Chemical or Other Material

  STERILITY ISSUE, HAIR IN STERILE PACK: CMC EXTREMITY PACK OPENED ON BACK TABLE. REMOVED SELF-CONTAINED STERILE SPLASH BASIN PACK TO RING STAND. UPON OPENING THE STERILE WRAP ENCLOSING THE SPLASH BASIN, SAW A HAIR AGAINST THE SIDEWALL OF THE INNER BASIN. SPLASH AND CONTENTS NOT USED; ADDITIONAL STERILE SUPPLIES OBTAINED.

  Patient problems: No Patient Involvement

  MAUDE report 9888212 ↗
• MalfunctionMar 3, 2020Contamination /Decontamination Problem

  EXTREMITY PACK CDEX31D OPENED AND DISCOVERED THE ASEPTO CONTAINED WITHIN THE PACK HAD A BROWNISH SUBSTANCE ON THE BULB. PACK AND CONTENTS DISCARDED AND NEW PACK OBTAINED. NO PATIENT EXPOSURE; PRIOR TO PATIENT ENTERING OPERATING ROOM. ASEPTO AND PACKING LIST SAVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9779436 ↗
• MalfunctionDec 17, 2019Contamination /Decontamination Problem

  QUESTIONABLE STERILITY ISSUE W/ STERILE SUPPLY PACK. HAIR WAS DISCOVERED WITHIN THE INITIAL FAN FOLDS OF THE PACK. HAIR APPROXIMATELY 1 CM IN LENGTH. DISCOVERED WHEN OPENING FOR SURGICAL PROCEDURE. PACK DISCARDED & ANOTHER OBTAINED. NO BREAK IN ASEPTIC TECHNIQUE, NO PATIENT EXPOSURE, NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9480758 ↗
• MalfunctionNov 15, 2019Device Contamination with Chemical or Other Material

  HAIR DISCOVERED IN THE PACK. THE HAIR WAS BLACK AND APPROXIMATELY 12" LONG; HAIR WAS IN IRRIGATION TUB WITH A PORTION OF THE HAIR HANGING OUT AND OVER THE EDGE OF THE IRRIGATION TUB. PT WAS NOT IN THE ROOM. THE HAIR AND IRRIGATION TUB WERE NOT SAVED. PACK AND CONTENTS DISCARDED AND NEW SETUP INITIATED WITH NEW PACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9327659 ↗
• MalfunctionSep 18, 2019Contamination of Device Ingredient or Reagent

  DURING CASE SET UP THE ASEPTO IN THE EXTREMITY PACK HAD AN UNKNOWN SUBSTANCE ON IT. THE PACK AND ALL INSTRUMENTS WERE REMOVED. NEW SET UP STARTED. PATIENT WAS NOT IN THE ROOM. PACK SAVED.

  Patient problems: No Patient Involvement

  MAUDE report 9081665 ↗
• MalfunctionMay 3, 2019Delivered as Unsterile Product

  STERILITY ISSUE: DURING CASE SET UP THE STERILE EXTREMITY PACK WAS OPENED. THE CLEAR COVER WAS TORN OPEN AT WHICH POINT A HAIR WAS SEEN ON THE INSIDE OF THE CLEAR PACKAGE ON THE OUTSIDE OF THE BLUE TABLE COVER. PACK REMOVED FROM USE AND NEW PACK USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8577286 ↗
• MalfunctionMay 1, 2019Device Contamination with Chemical or Other Material

  WHILE OPENING PACK FOR THE CASE THE SCRUB PERSON OPENED ONE SIDE OF THE WRAP AND FOUND A HAIR ON THE INSIDE OF THE DRAPE. THE PACK WAS REMOVED FROM USE AND A NEW PACK WAS OBTAINED. THIS OCCURRED PRIOR TO THE PATIENT ENTERING THE ROOM.

  Patient problems: No Patient Involvement

  MAUDE report 8568613 ↗
• MalfunctionMar 11, 2019Delivered as Unsterile Product

  A HAIR WAS FOUND IN THE CMC EXTREMITY PACK PRIOR TO THE PATIENT ENTERING THE ROOM. STATED THAT THE HAIR WAS FOUND ON INSIDE FOLD AREA OF THE PACK. THE PACK WAS REMOVED FROM THE ROOM. A NEW ONE WAS OBTAINED.

  Patient problems: No Patient Involvement

  MAUDE report 8407232 ↗
• MalfunctionJan 24, 2019Device Contamination with Chemical or Other Material

  HAIR, POSSIBLY EYELASH OR EYEBROW, WAS DISCOVERED IN THE BLUE BASIN IN THE PACK DURING SETUP. CONTAMINATED PACK WAS REMOVED AND DISCARDED. NEW PACK OBTAINED TO RESET STERILE FIELD. NO PATIENT EXPOSURE TO CONTAMINANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273225 ↗