The Recall Desk
HighFDA (Devices)·Z-0815-2025·Announced 2025-01-15

Tec 820 ISO Anesthesia Vaporizers can deliver less anesthetic than dial setting

GE Medical Systems is recalling 644 Tec 820 ISO Anesthesia Vaporizers due to a manufacturing issue that causes them to deliver less anesthetic than the dial setting indicates. Distributed nationwide 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: This is a FDA Class II recall for a confirmed manufacturing defect in a critical surgical device. The defect can cause under-delivery of anesthetic agent, creating risk of inadequate anesthesia during procedures. No injuries or adverse events are reported in the recall notice.

Plain-English summary

GE Medical Systems, LLC is recalling the Tec 820 ISO Anesthesia Vaporizer (Reference Number 1177-9820-ISO) due to a manufacturing issue. The recall affects 644 units distributed throughout the United States and globally.

The identified manufacturing issue can cause affected vaporizers to deliver less anesthetic agent than the vaporizer dial setting indicates. This could result in patients receiving inadequate anesthesia during surgical procedures.

Affected units are identified by specific serial numbers listed in the recall notice. This is a Class II recall issued by the FDA with recall number Z-0815-2025.

The recalled product

Product
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Anesthesia Equipment
Hazard
  • under-dosing

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: 00840682124744

Distribution

Distributed nationwide across the United States.

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