Z-0721-2026Class II

Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso...

Name: Z-0721-2026 Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2025-10-20
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2025-10-20 / Open, Classified / root cause: design

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number... on 2025-10-20. FDA classified it as Class II and gives the reason as "Potential for anesthesia leakage". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0721-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-20
Posted: 2025-11-26
Recalling firm: Datascope Corp.
Product: Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. 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.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Potential for anesthesia leakage.
Root cause tag: design
FDA root cause: Device Design
Action: Mindray notified consignees on about 10/20/2025 via letter. Consignees were informed that they could continue using the units as normal, but if an anesthetic odor or leak is detected, contact Mindray Technical Support. Interventions may include switching to another V90 vaporizer or using intravenous anesthesia as clinically appropriate. For vaporizer replacement procedures, refer to A9 Operator s Manual (Part No. H-046-017199-00, Section 3.4 Vaporizer ), available on the Mindray website. Mindray s Technical Support team can assist and may be reached at (877) 913-9663 (Option 2) Monday through Friday, 8:30 a.m. 5:30 p.m. ET. Consignees were instructed to complete and return the Acknowledgement and Receipt form provided, ensure that all applicable clinical staff are aware of the issue and maintain a copy of the recall notification with affected units or IFUs. Additionally, they were instructed to notify any organization to which the affected V90 electronic vaporizers identified have been distributed. The Mindray Care Team will contact consignees to arrange the replacement of all affected SEVO and ISO V90 electronic vaporizers located at their facility. The V90 electronic vaporizers will be shipped directly to each facility, and a Mindray Care Team representative will schedule the installation and collect the affected V90 electronic vaporizers.
Quantity in commerce: 54 units
Distribution: Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.
Product codes and lots: 1. Part Number 115-066758-00; DI 06936415975753; Serial Numbers: AH6B44000714, AH6B44000719, AH6B44000722, AH6B44000724, AH6B44000733, AH6B44000734, AH6B44000782, AH6B45000836, AH6B45000837, AH6B45000840, AH6B45000844, AH6B45000858, AH6B44000717, AH6B44000786, AH6B44000785, AH6B44000788, AH6B45000859, AH6B44000671, AH6B44000673, AH6B44000705, AH6B44000706, AH6B44000707, AH6B44000708, AH6B44000709, AH6B44000710, AH6B44000711, AH6B44000712, AH6B44000713, AH6B44000715, AH6B44000716, AH6B44000718, AH6B44000723, AH6B44000725, AH6B44000726, AH6B44000727, AH6B44000728, AH6B44000729, AH6B44000730, AH6B44000731, AH6B44000783, AH6B44000787, AH6B44000790, AH6B45000839, AH6B45000854, AH6B44000732, AH6B45000856, AH6B44000789, AH6B45000842, AH6B45000841, AH6B45000845, AH6B45000850, AH6B45000852, AH6B45000853. 2. Part Number E115-066758-00; 06936415975753; Serial Number: AH6B44000672.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0721-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0720-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26
Z-0721-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26

Product code BSZ

K201957Class IIA8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2021-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)