FDA Medical Device Recalls (openFDA)
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 number
- Z-1104-04
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No. 48-154.
- Status
- Terminated
- Initiated
- 2004-06-16
- Posted
- 2004-07-20
- Terminated
- 2005-02-11
- Reason
- Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.
- Root cause
- Other
- Action
- Recall letters dated June 16, 2004 were sent to consignees requesting product return.
- Quantity
- 1840
- Distribution
- Nationwide and Netherlands.
- Lot, serial or model codes
- Lots 6015906, 6028660, 6048137 and 6048138.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DRE
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28