FDA Medical Device Recalls (openFDA)
Medisurg Research & Management Corp: Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton.
- Recall number
- Z-1224-06
- Recalling firm
- Medisurg Research & Management Corp
- Product
- Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton.
- Status
- Terminated
- Initiated
- 2006-04-28
- Posted
- 2006-08-02
- Terminated
- 2006-09-08
- Reason
- No documentation to support shelf life/sterility
- Root cause
- Other
- Action
- On 4/28/06, the recalling firm faxed a notification to the customers informing them not to use the product during surgery and to return the product.
- Quantity
- 960 tips
- Distribution
- Nationwide, including CA, CT, FL, GA, MA, NC, NY, OH, OR, PA, TX, and WI.
- Lot, serial or model codes
- Lot numbers 01013786, 01017917, 01017918, 01017684 and 01017442
- 510(k) numbers
- ["K001498"]
- PMA numbers
- not on file
- Product code
- NCR
- Firm FEI
- 3003408230
- Firm city
- Norristown
- Firm state
- PA
- 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