FDA Medical Device Recalls (openFDA)
Aspen Surgical Products, Inc.: Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery.
- Recall number
- Z-1337-2011
- Recalling firm
- Aspen Surgical Products, Inc.
- Product
- Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery.
- Status
- Terminated
- Initiated
- 2010-12-23
- Posted
- 2011-02-16
- Terminated
- 2011-10-07
- Reason
- Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
- Root cause
- Component design/selection
- Action
- Aspen Surgical sent URGENT MEDICAL DEVICE RECALL NOTICES dated 12/23/2010 by Certified Mail. The letters instructed the users to examine their inventory and place the recalled products in quarantine. Consignees were instructed to return the product and complete the response form. Distributors were asked to notify their customers or requesting that Aspen notify the customers. The firm does not intend to continue manufacturing or distributing the product.
- Quantity
- 77850 all products
- Distribution
- Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
- Lot, serial or model codes
- 2010-12-09, 2013-02-23, 2013-08-12, 2013-09-24.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HMR
- Firm FEI
- 3002750084
- Firm city
- Caledonia
- Firm state
- MI
- 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