Data Foundry

Medical device recalls 2025

Sevoflurane — Class II medical device recall Z-0720-2026

Ongoing recall by Mindray DS USA, Inc. dba Mindray North America, reported 2025-12-03, distributed nationwide. Potential for anesthesia leakage.

Recall numberZ-0720-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States
Recall initiated2025-10-20
Classified2025-11-26
Reported by FDA2025-12-03
DistributedNationwide (US)
Countries outside the USCA
Quantity148 units
Reason classespackaging
UPC / GTIN / UDI-DI06936415975777
Serial numbersAH6A28000535, AH6A44000645, AH6A44000647, AH6A44000648, AH6A44000649, AH6A44000650, AH6A44000651, AH6A44000652, AH6A44000655, AH6A44000656, AH6A44000657, AH6A44000658, AH6A44000659, AH6A44000660, AH6A44000661, AH6A44000662, AH6A44000664, AH6A44000674, AH6A44000676, AH6A44000677, AH6A44000678, AH6A44000679, AH6A44000680, AH6A44000681, AH6A44000682 and 123 more
Model numbers115-066756-00, E115-066756-00

Product

Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.

Reason for recall

Potential for anesthesia leakage.

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-0720-2026. 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.