Recall Z-0934-2026— Draeger, Inc.

Name: FDA recall Z-0934-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-24

Class I · Ongoing

Class I FDA medical device recall by Draeger, Inc., initiated 2025-11-24. It names one FDA 510(k) clearance: K971923. Product: Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.. Reason: A certain component of affected devices was not delivered within specification and contained impurities..

Recalling firm: Draeger, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-11-24
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K971923 — DRAGER-VAPOR 2000Draeger Medical, Inc.·cleared 1997-09-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

Reason for recall

A certain component of affected devices was not delivered within specification and contained impurities.

Data sourced from openFDA. This site is unofficial and independent of the FDA.