FDA Medical Device Recalls (openFDA)
Surgical Specialties Puerto Rico, Inc.: Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled, full handle, 2.85mm
- Recall number
- Z-0945-04
- Recalling firm
- Surgical Specialties Puerto Rico, Inc.
- Product
- Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled, full handle, 2.85mm
- Status
- Terminated
- Initiated
- 2004-03-03
- Posted
- 2004-07-20
- Terminated
- 2004-09-10
- Reason
- Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
- Root cause
- Other
- Action
- Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.
- Quantity
- not on file
- Distribution
- Distribution was nationwide and internationally
- Lot, serial or model codes
- Model No. Lot # Exp. date 52-2835 M454660 2/2009 52-2835 M317210 7/2008
- 510(k) numbers
- ["K822112"]
- PMA numbers
- not on file
- Product code
- HNN
- Firm FEI
- 3008845715
- Firm city
- Rincon
- Firm state
- not on file
- Firm country
- PR
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