Vaporizer Sevoflurane, QUIK FIL 6682285Recalls & reported problems
Maquet Critical Care AB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
8 other recalls cover devices cleared under the same FDA submission (K133958); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jan 15, 2025Class IOpen, Classified
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
Z-1074-2025 · Root cause: Device Design · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K133958. One submission often covers many models, so check the product and lot details in each record.
- Z-0991-2024 · Dec 11, 2023 · Open, ClassifiedFlow-e Anesthesia System, model 6887900
- Z-0988-2024 · Dec 11, 2023 · Open, ClassifiedFlow-i C30 Anesthesia System, model 6677300
- Z-0990-2024 · Dec 11, 2023 · Open, ClassifiedFlow-c Anesthesia System, model 6887700
- Z-0989-2024 · Dec 11, 2023 · Open, ClassifiedFlow-i C40 Anesthesia System, model 6677400
- Z-0987-2024 · Dec 11, 2023 · Open, ClassifiedFlow-i C20 Anesthesia System, model 6677200
- Z-0804-2016 · Dec 10, 2015 · TerminatedFlow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients
- Z-1706-2015 · Apr 2, 2015 · TerminatedFLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
- Z-2083-2015 · Mar 2, 2015 · TerminatedThe FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while con
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- Carestation 620 A1Datex-Ohmeda Inc · Gas-machine, anesthesia2 recalls2,015 reports
- Avance CS2Datex-Ohmeda Inc · Gas-machine, anesthesia6 recalls1,540 reports
- Flow-c Anesthesia System 6887700Maquet Critical Care AB · Gas-Machine, Anesthesia6 recalls72 reports
- FLOW-i C20 6677200Maquet Critical Care AB · Gas-Machine, Anesthesia4 recalls99 reports
- Flow-e Anesthesia System 6887900Maquet Critical Care AB · Gas-Machine, Anesthesia5 recalls19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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