OPSITE FLEXIGRID USA 10X12CM CARTON OF 10 66024629, 66024630Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05000223415419), received between Jan 4, 2021 and Jan 21, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING A WOUND TREATMENT, IT WAS NOTICED THAT THE OUTER PACKAGING OF ONE (1) DRESSING FROM ONE (1) OPSITE FLEXIGRID 10X12CM CTN 50 WAS NOT PROPERLY SEALED AND HAD A TEAR, COMPROMISING THE STERILITY. THE TREATMENT WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137770 ↗
• MalfunctionJan 16, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE A INDWELLING PUNCTURE TREATMENT, IT WAS NOTICED THAT THE SEAL OF ONE (1) DRESSING OF ONE (1) OPSITE FLEXIGRID 10X12CM CTN 50 WAS NOT TIGHT AND THE STERILE STATE OF THE PRODUCT HAD BEEN COMPROMISED. THE TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24103877 ↗
• MalfunctionAug 22, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION FOR TREATMENT, THE INDIVIDUAL POUCH OF ONE (1) OPSITE FLEXIGRID 10X12CM CTN 50 WAS NOT SEALED. THE TREATMENT WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025039 ↗
• MalfunctionJun 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT,A OPSITE FLEXIGRID WAS TOO ADHESIVE TO BE REMOVED FROM THE BACK LINER. THE TREATMENT WAS RESUMED WITH A BACK UP DRESSING. PATIENT WAS NOT IMPACTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096698 ↗
• MalfunctionJun 17, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT AN OPSITE FLEXIGRID 10X12CM COULD NOT BE PEELED OFF. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021654 ↗
• MalfunctionFeb 4, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE OPSITE FLEXIGRID DOES NOT HAVE THE EXPIRE DATE PRINTED. INCIDENT WAS IDENTIFIED BY THE DISTRIBUTOR. NO PROCEDURE/PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282042 ↗
• MalfunctionJan 8, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT CUSTOMER AFTER GETTING A TATTOO USED OPSITE 6X7 TO TRY AND COVER HER PIECE AND THE ENDS KEPT CURLING UP, CUSTOMER USED HOSPITAL TAPE TO HOLD THEM DOWN, HOWEVER THAT CAUSED THE FILM TO COME OFF FURTHER THEN CUSTOMER USED OPSITE 10X12 TO ENSURE IT WAS FULLY COVERED AND THE SECOND SEALED THAT HOWEVER CUSTOMER STILL HAS A LARGE PIECE THAT HAS NOT STUCK DOWN. NO HARM OR INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139698 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALTHOUGH THE PATIENT'S SKIN WAS ASSESSED TO BE ABLE TO WITHSTAND MARKING WITH FILM, A SUPERFICIAL SKIN DEFECT OCCURS BECAUSE THE ADHESIVE OF THE FILM PULLED A FLAP OFF THE TOP LAYER OF SKIN. A CHANGE IN PROCEDURE WAS IMPLEMENTED WITH A MORE SUITABLE SILICONE FILM FROM S+N WITH A SMALL DELAY IN TREATMENT, THEREFORE CUSTOMER IS FINE.

  Patient problems: Skin Tears

  MAUDE report 11113777 ↗