FDA Medical Device Recalls (openFDA)
Aspen Surgical Products, Inc.: Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.
- Recall number
- Z-0828-03
- Recalling firm
- Aspen Surgical Products, Inc.
- Product
- Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.
- Status
- Terminated
- Initiated
- 2003-04-30
- Posted
- 2003-05-15
- Terminated
- 2003-11-13
- Reason
- Sterility compromised - incomplete sterile package seal.
- Root cause
- Packaging process control
- Action
- The firm called each customer on 4/30/03 and requested that the product be returned. Distributors were asked to notify their customers of the recall.
- Quantity
- 299 boxes
- Distribution
- Nationwide, Japan and United Kingdom.
- Lot, serial or model codes
- Lot 2005-02-17. Exp. February 2005.
- 510(k) numbers
- K932449
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3002750084
- Firm city
- Byron Center
- 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