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.

Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia Recalled by King Systems Corp. Due to King Systems received a customer complaint indicating that...

Date: August 23, 2012
Company: King Systems Corp.
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 King Systems Corp. directly.

Affected Products

Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Quantity: 1 case; 40 units

Why Was This Recalled?

King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About King Systems Corp.

King Systems Corp. has 15 total recalls tracked by RecallDetector.

Related Recalls

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