The Recall Desk
HighFDA (Devices)·Z-0814-2025·Announced 2025-01-15

Anesthesia Vaporizers May Deliver Less Anesthetic Than Dial Setting Due to Manufacturing Defect

Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported injuries or deaths. The hazard—under-delivery of anesthetic—poses a real risk to patient safety but no harm has been reported, meeting the rubric criterion for risk-of-harm products without reported injuries.

Plain-English summary

Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers, manufactured by GE Medical Systems, LLC, are subject to recall. Due to a manufacturing issue, these vaporizers may deliver a lower concentration of anesthetic agent than the setting indicated on the vaporizer dial.

Approximately 1,573 units are affected by this recall, distributed in the United States and globally. When a vaporizer delivers less anesthetic than the dial setting, the actual anesthetic concentration delivered to the patient differs from what the operator intended.

The recalled product

Product
Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M122
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Anesthesia Equipment
Hazard
Affected units
1,573

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)

  • REF 1107-9601-000
  • GTIN 0084068211253
  • REF 1107-9602-000
  • GTIN 00840682112659
  • REF 1107-9603-000
  • GTIN 00840682112574
  • REF 1107-9604-000
  • GTIN 00840682112925
  • REF 1107-9610-000
  • GTIN 00840682112864
  • REF 1107-9612-000
  • GTIN 00840682113236
  • REF 1107-9616-000
  • GTIN 00840682113069
  • REF 1107-9617-000
  • GTIN 00840682112666
  • REF 2066835-001
  • GTIN 00840682112857
  • REF 2069767-001
  • GTIN 00840682112505

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by GE Medical Systems, LLC 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 5 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems, LLC

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Same hazard · anesthetic under delivery

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