Halyard 76885Recalls & reported problems

O&M Halyard, Inc. · T.U.R. Drape 114 in. x 69 in. x 67 in. 289 cm x 175 cm x 170 cm · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30680651768859), received between Dec 20, 2024 and Dec 20, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Contamination1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 20, 2024Contamination; Contamination
THERE WERE LARGE HOLES THAT PRESENTED IN THE SEAM OF THE DRAPE DURING SURGERY. THIS CAUSED A BREECH IN STERILITY DURING OPERATION. ADDITIONAL INFORMATION WAS REQUESTED ON NOVEMBER 26, 2024, NOVEMBER 28, 2024, AND DECEMBER 2, 2024, AND HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20987578 ↗

Device details

UDI-DI	`30680651768859`
Brand	Halyard
Model	76885
Company	O&M Halyard, Inc.
Product code	PUI · Drape, surgical, exempt
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 26, 2024

Device type (GMDN): Patient surgical drape, single-use

A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

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All Drape, surgical, exempt devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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