Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile) Recalled by Halyard Health, Inc Due to Drapes within the affected lots may include a...

Date: November 9, 2016
Company: Halyard Health, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Halyard Health, Inc directly.

Affected Products

Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear Screen (Sterile), Product Code 44968 00; C-Section Drape with Pouch and Fenestration (Non-Sterile), Product Code 44977 NS; C-Section Drape with Pouch and Fenestration (Sterile), Product Code 44978 00 Product Usage: A surgical drape is a device made of natural or synthetic materials intended to be use as a protective patient covering, such as to isolate a site or surgical incision from microbial and other contamination.

Quantity: 132 cases

Why Was This Recalled?

Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Halyard Health, Inc

Halyard Health, Inc has 48 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report