FDA Medical Device Recalls (openFDA)
Microvision Medical Holding B.V.: MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand
- Recall number
- Z-1435-06
- Recalling firm
- Microvision Medical Holding B.V.
- Product
- MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand
- Status
- Terminated
- Initiated
- 2006-07-21
- Posted
- 2006-08-23
- Terminated
- 2006-11-15
- Reason
- Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier
- Root cause
- Other
- Action
- The recalling firm issued a recall letter dated 7/21/06 to their customers informing them of the problem and the need to return the product.
- Quantity
- 540 caps
- Distribution
- World wide-The product was shipped to physicians in UT, IA, OR, MA, LA, CA. The product was also shipped to Germany, United Kingdom, and The Netherlands.
- Lot, serial or model codes
- Lot number 583546
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSO
- Firm FEI
- 3005121848
- Firm city
- Amsterdam
- Firm state
- not on file
- Firm country
- Netherlands
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