FDA Medical devices recall ·
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO recall
- Recall number
- Z-0815-2025
- Date
- (initiated November 18, 2024)
- Company / brand
- GE Medical Systems, LLC
3000 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 644 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Why was it recalled?
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN: 00840682124744; Serial Numbers: SQAD01037 SQAD01038 SQAD01041 SQAC01464 SQAC01467 SQAC00988 SQAC00987 SQAD01184 SQAD01219 SQAD01221 SQAD01222 SQAC01106 SQAD00048 SQAD00057 SQAD00059 SQAD00116 SQAD00124 SQAD00127 SQAD00129 SQAD00134 SQAD00136 SQAD00137 SQAD00139 SQAD00144 SQAD00576 SQAD00577 SQAD00581 SQAC00844 SQAC00851 SQAC00852 SQAC00854 SQAC00855 SQAC00856 SQAC00857 SQAC00858 SQAC00930 SQAC00842 SQAC00895 SQAC00517 SQAC01192 SQAD00860 SQAC01203 SQAC00989 SQAC00990 SQAC01186 SQAD00142 SQAD00486 SQAD00498 SQAD00831 SQAD00853 SQAD00855 SQAD00856 SQAD00857 SQAD00862 SQAD00863 SQAD00871 SQAD00873 SQAD00881 SQAD00883 SQAD00887 SQAD01109 SQAD01117 SQAD01168 SQAD00704 SQAD00736 SQAD00720 SQAD00747 SQAD00754 SQAD00761 SQAD00784 SQAD01031 SQAD01033 SQAD00523 SQAD00527 SQAD00583 SQAC01468 SQAD00140 SQAD00143 SQAD00808 SQAC01367 SQAC01389 SQAC01397 SQAC01190 SQAD00870 SQAD00859 SQAC01424 SQAC00881 SQAC01457 SQAC01476 SQAC01494 SQAC01445 SQAC01373 SQAC01435 SQAC01447 SQAC01361 SQAD00202 SQAC00941 SQAD00438 SQAD00439 SQAD00441 SQAC00811 SQAC01451 SQAD00024 SQAC00953 SQAD00200 SQAD00201 SQAD00199 SQAD00412 SQAD00413 SQAD00414 SQAD00416 SQAD00417 SQAD00419 SQAD00420 SQAD00421 SQAD00422 SQAD00423 SQAD00424 SQAD00425 SQAD00427 SQAD00428 SQAD00429 SQAD00430 SQAD00431 SQAD00433 SQAD00434 SQAD00435 SQAD00198 SQAC01507 SQAD00017 SQAD00031 SQAD00189 SQAD00220 SQAC01503 SQAC01508 SQAC01453 SQAC01461 SQAD00203 SQAC01220 SQAC01224 SQAC01215 SQAC01232 SQAC01233 SQAC01237 SQAC01458 SQAC01281 SQ
Distribution
US Nationwide. Global Distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0815-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.