The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0077-2025·Announced 2024-10-30

Datex-Ohmeda Aespire View Anesthesia Machines Recalled for Connection Error Risk

Datex-Ohmeda is recalling 10,338 Aespire View anesthesia machines due to a potential issue where a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet port.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port."

Plain-English summary

Datex-Ohmeda, Inc. is recalling 10,338 units of the Aespire View anesthesia gas machine. These devices are intended to provide general inhalation anesthesia and ventilatory support to patients and are used by medical professionals trained in the administration of general anesthesia.

The recall is issued due to a potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. The source text does not specify reported injuries, illnesses, or fatalities associated with this defect.

The affected units were distributed worldwide, including the United States and numerous international countries. The recall number is Z-0077-2025. Medical professionals should verify their equipment against the provided model numbers and GTIN to determine if their units are affected.

The recalled product

Product
Aespire View. 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 Machine
Hazard
Affected units
10,338

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 (20)

  • GTIN: 00840682102285. Model Numbers: 1009-9212-000-117639
  • 1009-9212-000-136105
  • 1009-9212-000-518222
  • 1009-9212-000-521025
  • 1009-9212-000-552778
  • 1009-9212-000-090755
  • 1009-9212-000-059245
  • 1009-9212-000-110073
  • 1009-9212-000-203581
  • 1009-9212-000-423283
  • 1009-9212-000-419502
  • 1009-9212-000-427555
  • 1009-9212-000-460867
  • 1009-9212-000-478499
  • 1009-9212-000-109510
  • 1009-9212-000-521303
  • 1009-9212-000-097620
  • 1009-9212-000-102602
  • 1009-9212-000-520908
  • 1009-9212-000-098765

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.

See all →

Same hazard · misconnection

See all →

Similar recalls