Vapor 3000 anesthetic vaporizers recalled over an out of specification component
Draeger is recalling 188 Vapor 3000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The Draeger Vapor 3000, an unheated calibrated anesthetic vaporizer, model M36500, is being recalled.
A certain component of affected devices was not delivered within specification and contained impurities.
The record lists 188 units carrying UDI-DI 04048675301363, with serial numbers listed in the enforcement record including ASUK-1181, ASUK-1186, ASUK-1187, ASUK-1196 and ASUK-1197. Distribution was worldwide, including nationwide in the United States across Alaska, California, Florida, Iowa, Kansas, Maryland, Maine, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, South Dakota and Tennessee. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine affected stock immediately and follow Draeger's instructions.
The recalled product
- Product
- Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
- Manufacturer
- Draeger, Inc.
- Hazard
- out-of-specification
- impurities
- anesthesia
- class-i
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)
- Model No. M36500
- UDI-DI: 04048675301363
- Serial No. ASUK-1181
- ASUK-1186
- ASUK-1187
- ASUK-1196
- ASUK-1197
- ASUK-1198
- ASUK-1199
- ASUK-1200
- ASUK-1201
- ASUK-1202
- ASUK-1203
- ASUK-1204
- ASUK-1205
- ASUK-1206
- ASUK-1207
- ASUK-1208
- ASUK-1209
- ASUK-1210
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- SevereMEDLINE Medical Procedure Kits Containing Bupivacaine Recalled Due to Drug Ineffectiveness
FDA (Devices) · 2026-07-29
- HighFARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall
FDA (Devices) · 2026-07-29
- HighBoston Scientific Recalls FARASTAR Ablation Generators Due to Catheter Incompatibility
FDA (Devices) · 2026-07-29
- HighPenumbra System RED 68 Reperfusion Catheter Recall Due to Fracture Risk
FDA (Devices) · 2026-07-29