Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit Recalled by Fisher & Paykel Healthcare, Ltd. Due to FPH has become aware that one batch of...

Date: November 19, 2012
Company: Fisher & Paykel Healthcare, Ltd.
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 Fisher & Paykel Healthcare, Ltd. directly.

Affected Products

Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.

Quantity: 200 units total, 26 units US

Why Was This Recalled?

FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int

Where Was This Sold?

This product was distributed to 4 states: AR, GA, IL, IN

Affected (4 states)Not affected

About Fisher & Paykel Healthcare, Ltd.

Fisher & Paykel Healthcare, Ltd. has 7 total recalls tracked by RecallDetector.

Related Recalls

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