FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold individually as UPN M0067301250 and in packaged of ten as UPN M0067301251.
- Recall number
- Z-1300-06
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold individually as UPN M0067301250 and in packaged of ten as UPN M0067301251.
- Status
- Terminated
- Initiated
- 2006-06-30
- Posted
- 2006-07-27
- Terminated
- 2008-07-31
- Reason
- Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.
- Root cause
- Package design/selection
- Action
- U.S. accounts were notified via recall letter dated 6/30/06 to cease use of the product and to return it to the firm. International accounts were also notified.
- Quantity
- 446,097 units
- Distribution
- Nationwide and worldwide, including Argentina, Bangladesh, Belgium, Canada, Chile, China, Colombia, Dominican Republic, Egypt, El Salvador, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Portugal, Romania, South Africa, Spain, Sri Lanka, Sweden, Tunisia, Turkey and Venezuela.
- Lot, serial or model codes
- All lots expiring on or before June 12, 2010.
- 510(k) numbers
- ["K880099"]
- PMA numbers
- not on file
- Product code
- KOG
- 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