Boston Scientific Corp Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154.
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Lots 6015906, 6028660, 6048137 and 6048138.
Products Sold
Lots 6015906, 6028660, 6048137 and 6048138.
Boston Scientific Corp is recalling Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M00 due to Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.
Recommended Action
Per FDA guidance
Recall letters dated June 16, 2004 were sent to consignees requesting product return.
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