VIASYS Med Systems Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Brand
VIASYS Med Systems
Lot Codes / Batch Numbers
Part #10450, Catalog # SA-500/US, lot number 16963
Products Sold
Part #10450, Catalog # SA-500/US, lot number 16963
VIASYS Med Systems is recalling Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the Free due to The packaging may be compromised such that sterility of the hoods cannot be guaranteed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
Recommended Action
Per FDA guidance
VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/13/05. The accounts were informed of the potential for compromised packages seals and questionable sterility, and were instructed to check their inventory for the affected catalog numbers and lots numbers. The accounts were instructed to hold any affected product and contact VIASYS at 1-800-323-6305 to arrange for the return goods authorization. The dealers were requested to sub-recall the affected product from their customers.
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