Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
Brand
Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom
Lot Codes / Batch Numbers
Lot Number: 634418
Products Sold
Lot Number: 634418
Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom is recalling Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890 due to Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label
Recommended Action
Per FDA guidance
Smiths Medical notified 8 accounts by letter dated June 3, 2005. Distributors are requested to contact accounts end-users (hospitals) . Users are requested to return inventory.
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 noticeDistribution
As reported by FDA
CA, NJ, PA, WV
Page updated: Jan 10, 2026