Drape, Surgical, Exempt
FDA adverse event reports and recall history for drape, surgical, exempt (product code PUI), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 471
- Deaths
- 0
- Injuries
- 62
- Malfunctions
- 408
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R; 2) MAJOR, Medline Kit Number/SKUDYNJ904851I; 3) ABDOMINAL TRANSPLANT, Medline Kit Number/SKUDYNJ908124B.
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE medical convenience kits labeled as (list truncated)
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N; 2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D; 3) OB/GYN, Medline Kit Number/SKU DYNJ911652.
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M; 3) TAH PACK, Medline Kit Number/SKU DYNJ60646A; 4) TUBAL LIGATION RFD, Medline Kit Number/SKU DYNJ906291F.
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- 2026-10-22Open, ClassifiedUnder Investigation by firm
MEDLINE medical convenience kits labeled as: (list truncated)
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
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Monitor drape, surgical, exempt automatically
DeviceWatch monitors available FDA adverse events and recalls. Growth includes event alerts for Death and Injury reports; Compliance Pro adds safety signals for investigation. FDA publication delays and incomplete collection or analysis coverage limit detection; no signal does not establish the absence of a safety concern. AI summaries and signals are provisional and require human review.