FDAClass IIDecember 3, 2025

Sevoflurane recall

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.

Why was Sevoflurane recalled?

Potential for anesthesia leakage.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1. Part Number: 115-066756-00; DI: 06936415975777; Serial Numbers: AH6A45000871, AH6A45000880, AH6A45000881, AH6A46000929, AH6A46000931, AH6A46000944, AH6A47001200, AH6A44000657, AH6A44000658, AH6A44000661, AH6A44000664, AH6A44000677, AH6A44000678, AH6A44000680, AH6A44000768, AH6A44000778, AH6A46000925, AH6A46000927, AH6A46000928, AH6A46000935, AH6A46000937, AH6A46001114, AH6A47001159, AH6A47001164, AH6A47001174, AH6A47001201, AH6A45000872, AH6A46000932, AH6A46000939, AH6A46000940, AH6A47001196, AH6A47001202, AH6A47001207, AH6A47001215, AH6A46001102, AH6A46001111, AH6A46001116, AH6A47001160, AH6A47001161, AH6A47001163, AH6A47001165, AH6A47001166, AH6A47001167, AH6A47001178, AH6A46001097, AH6A46001117, AH6A44000645, AH6A44000647, AH6A44000648, AH6A44000651, AH6A44000655, AH6A44000656, AH6A44000659, AH6A44000660, AH6A44000662, AH6A44000684, AH6A44000686, AH6A44000687, AH6A44000688, AH6A44000690, AH6A44000691, AH6A44000695, AH6A44000696, AH6A44000698, AH6A44000700, AH6A44000702, AH6A44000703, AH6A44000770, AH6A44000776, AH6A46001090, AH6A46001109, AH6A46001118, AH6A47001171, AH6A47001176, AH6A44000771, AH6A44000772, AH6A45000815, AH6A45000819, AH6A45000821, AH6A45000822, AH6A45000824, AH6A45000825, AH6A45000829, AH6A45000832, AH6A45000834, AH6A45000835, AH6A45000868, AH6A45000869, AH6A45000870, AH6A45000873, AH6A45000874, AH6A45000875, AH6A45000876, AH6A45000877, AH6A45000878, AH6A45000882, AH6A45000883, AH6A45000884, AH6A46000926, AH6A46000930, AH6A46000936, AH6A46000943, AH6A44000779, AH6A44000674, AH6A44000692, AH6A44000777, AH6A45000879, AH6A47001170, AH6A44000765, AH6A44000769, AH6A47001175, AH6A28000535, AH6A46000918, AH6A46000923, AH6A46000924, AH6A46000934, AH6A46000938, AH6A46001091, AH6A46001093, AH6A46001099, AH6A46001100, AH6A46001101, AH6A46001103, AH6A46001104, AH6A46001107, AH6A46001108, AH6A46001110, AH6A46001113, AH6A47001177, AH6A44000679, AH6A44000683, AH6A44000689, AH6A44000697, AH6A44000649, AH6A44000650, AH6A44000652, AH6A44000676, AH6A44000681, AH6A44000682, AH6A44000699, AH6A44000704, AH6A44000766, AH6A44000773, AH6A44000775, AH6A44000780, AH6A47001216, AH6A44000693. 2. Part Number: E115-066756-00; DI: 06936415975777; Serial Number: AH6A45000885.

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.
Recalling firm
Mindray DS USA, Inc. dba Mindray North America
Quantity
148 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.
Recall date
December 3, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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