Halyard 89016Recalls & reported problems

O&M Halyard, Inc. · SURG LOW-EX DRAPE · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651890167), received between Apr 12, 2024 and Apr 12, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (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

Material Puncture/Hole1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
No Consequences Or Impact To Patient1

Recent adverse event reports

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

InjuryApr 12, 2024Material Puncture/Hole; Material Puncture/Hole
STAFF OPENED THE DRAPES ASEPTICALLY USING THE INNER WRAPPER. WHEN THEY CHECKED THE INNER WRAPPER (CSR WRAP) FOR HOLES THEY FOUND PIN HOLES IN THE WRAPPER. THIS CONTAMINATED THE WHOLE BACK TABLE AND CAUSED A DELAY IN SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Consequences Or Impact To Patient
MAUDE report 19099013 ↗

Device details

UDI-DI	`10680651890167`
Brand	Halyard
Model	89016
Company	O&M Halyard, Inc.
Product code	PUI · Drape, Surgical, Exempt
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 22, 2021

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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