The Recall Desk
SevereFDA (Devices)·Z-0075-2025·Announced 2024-10-30

Aespire 100 anesthesia machine breathing circuit misconnection FDA recall

Datex-Ohmeda Aespire 100 anesthesia machines are recalled due to potential misconnection of breathing circuit limbs to the Auxiliary Common Gas Outlet port, which could impair anesthesia or ventilation delivery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, establishing a minimum severity of Severe. FDA Class I classification indicates the device could cause serious adverse health consequences. Misconnection of the breathing circuit could result in improper anesthesia or ventilation delivery, potentially causing serious patient harm. No injuries or deaths are reported in the source material.

Plain-English summary

The Aespire 100 anesthesia gas machine, manufactured by Datex-Ohmeda, Inc., is a medical device used to deliver general inhalation anesthesia and ventilatory support during surgical procedures. The FDA has issued a Class I recall for this device.

The recall addresses a potential safety issue where a patient breathing circuit limb could be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the correct connection point. Such a misconnection could result in improper delivery of anesthesia or ventilation to the patient.

The Aespire 100 has been distributed worldwide, including throughout the United States and internationally to numerous countries. Healthcare facilities and operating rooms using this anesthesia machine may be affected.

Medical professionals should be aware of the correct connection points for breathing circuit limbs and verify all connections before patient use. For additional information or questions regarding this recall, healthcare facilities should contact Datex-Ohmeda, Inc., or the FDA.

The recalled product

Product
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Manufacturer
Datex-Ohmeda, Inc.
Category
Medical Device — Anesthesia Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GTIN: 00840682102261

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Datex-Ohmeda, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Related recalls

Same manufacturer · Datex-Ohmeda, Inc.

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Same hazard · misconnection

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