Data Foundry

Medical device recalls 2025

Draeger Vapor 3000 — Class I medical device recall Z-0934-2026

Ongoing recall by Draeger, Inc., reported 2025-12-31, distributed nationwide. A certain component of affected devices was not delivered within specification and contained impurities.

Recall numberZ-0934-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmDraeger, Inc., Telford, PA, United States
Recall initiated2025-11-24
Classified2025-12-23
Reported by FDA2025-12-31
DistributedNationwide (US)
Countries outside the USAE, AR, AU, BE, BR, CN, CZ, DE, EC, EG, ES, FR, GB, GR, GT, HU, ID, IL, JP, KE, MX, NO, NP, PA, PE, PH, PL, RO, RS, SA, SG, TH, TR, VN
Quantity188 units
Reason classesspecification failure
UPC / GTIN / UDI-DI04048675301363
Serial numbersASUK-0241, ASUK-0242, ASUK-0243, ASUK-0244, ASUK-0245, ASUK-0246, ASUK-0247, ASUK-0248, ASUK-0249, ASUK-0250, ASUK-0451, ASUK-0452, ASUK-0453, ASUK-0454, ASUK-0455, ASUK-0456, ASUK-0457, ASUK-0458, ASUK-0459, ASUK-0460, ASUK-0461, ASUK-0462, ASUK-0463, ASUK-0464, ASUK-0465 and 162 more
Model numbersM36500

Product

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0934-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.