Sunrise Medical 535D-X CF Continuous Flow Cylinder Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
535D-X CF Continuous Flow Cylinder
Brand
Sunrise Medical
Lot Codes / Batch Numbers
Model 535D-M6-CF, serial numbers 06195A051 through 06276B225, Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196, Model 535D-C-CF, serial numbers 06230A008 through 06230A124, Model 535D-D-CF, serial numbers 06230A001 through 06262B126, and Model 535D-E-CF, serial numbers 06230A055 through 06313B122.
Products Sold
Model 535D-M6-CF, serial numbers 06195A051 through 06276B225; Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196; Model 535D-C-CF, serial numbers 06230A008 through 06230A124; Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and Model 535D-E-CF, serial numbers 06230A055 through 06313B122.
Sunrise Medical is recalling 535D-X CF Continuous Flow Cylinder due to Cylinder could lose oxygen at high pressure after the filling process. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cylinder could lose oxygen at high pressure after the filling process
Recommended Action
Per FDA guidance
The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026