FDA Medical Device Recalls (openFDA)
Boston Scientific Marlbourgh: Adapter for ACMI Hysteroscope Catalog Number: 55035
- Recall number
- Z-1020-05
- Recalling firm
- Boston Scientific Marlbourgh
- Product
- Adapter for ACMI Hysteroscope Catalog Number: 55035
- Status
- Terminated
- Initiated
- 2005-07-28
- Posted
- 2005-07-19
- Terminated
- 2006-06-14
- Reason
- The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.
- Root cause
- Other
- Action
- Boston Scientifc notified accounts by letter dated June 28, 2005 via Federal Express. Accounts are requested to check invnetory and return. Any adapters out of box have no lot identification and can be tested per instructions
- Quantity
- not on file
- Distribution
- CA, DE, FL, MA, MO, MS, OH, NE, NY, PA, UT, WI
- Lot, serial or model codes
- Lot Number: 20410191
- 510(k) numbers
- not on file
- PMA numbers
- ["P000040"]
- Product code
- MNB
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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