Vaporizer, Anesthesia, Non-Heated
FDA adverse event reports and recall history for vaporizer, anesthesia, non-heated (product code CAD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 4,506
- Deaths
- 2
- Injuries
- 71
- Malfunctions
- 4,394
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-23Open, ClassifiedUnder Investigation by firm
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
- 2025-12-23Open, ClassifiedUnder Investigation by firm
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
- 2025-01-07Open, ClassifiedProcess control
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, M1221495, and M1233992
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- 2025-01-07Open, ClassifiedProcess control
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- 2025-01-07Open, ClassifiedProcess control
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- 2025-01-07Open, ClassifiedProcess control
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- 2025-01-07Open, ClassifiedProcess control
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- 2013-07-02TerminatedNonconforming Material/Component
Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.
- 2006-11-21TerminatedOther
Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane.
There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.
- 2006-07-04TerminatedOther
Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.
Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics.
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