Barrier, Absorbable, Adhesion
FDA adverse event reports and recall history for barrier, absorbable, adhesion (product code MCN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,556
- Deaths
- 30
- Injuries
- 1,247
- Malfunctions
- 61
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-04-25Open, ClassifiedUnder Investigation by firm
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Product was distributed in the United States without proper regulatory approval.
- 2012-06-21TerminatedPackaging process control
seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Sterility of product may be compromised due to packaging defect
- 2012-06-21TerminatedPackaging process control
seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Sterility of product may be compromised due to packaging defect
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