MEROCEL® 400402Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20681490105150), received between Oct 1, 2024 and Aug 11, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that After the hemostatic sponge was packed, ventilation through both nasal cavities was poor, causing soreness and a feeling of distension in both upper eyelids. It was removed 48 hours after the operation. The sponge was removed and replaced in a timely manner, with no serious injury. The patient is in good condition and everything is normal.

  Patient problems: Nasal Obstruction; Swelling/ Edema

  MAUDE report 50205054 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MEROCEL PRODUCT WAS STERILE AND PACKAGING WAS NOT DAMAGED. THE PATIENT UNDERWENT JAW CYST SURGERY AND MEROCEL SPONGE WAS USED BY PLACING INSIDE THE SURGICAL CAVITY ON THE JAW. THE SPONGE WAS PLACED IN THE PATIENT'S BODY FOR ABOUT 26 HOURS. USER INFORMED THE PATIENT THAT IT WAS USED TO STOP BLEEDING. THE SPONGE WAS REMOVED BY A DOCTOR. THREE WEEKS AFTER THE SURGERY, THE PATIENT FACE WAS SEVERELY SWOLLEN AND INFECTION WAS SUSPECTED.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 20343973 ↗