Dr. Fog Endoscopic Fog Prevention Kit recallZ-0828-03 · Aspen Surgical Products, Inc. · initiated Apr 30, 2003
Terminated All recalls posted in May 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aspen Surgical Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility compromised - incomplete sterile package seal.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-0828-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 30, 2003
- Posted by the FDA
- May 15, 2003
- Recalling firm
- Aspen Surgical Products, Inc.
- Quantity
- 299 boxes
- Product code
- GCJ
- FDA submissions
- K932449
- Distribution
- Nationwide, Japan and United Kingdom.
Product description
Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.
Code information (models, lots, serial numbers)
Lot 2005-02-17. Exp. February 2005.
Other devices under the same FDA submission
3 devices cleared under K932449 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dr. Fog® Treated Sponge DF-3120Aspen Surgical Products, Inc. · Anti fog solution and accessories, endoscopy11 reports
- Medline Anti-Fog, Sterile MD-1001EAspen Surgical Products, Inc. · Anti fog solution and accessories, endoscopy3 reports
- Dr. Fog® Solution With Sponge DF-3100Aspen Surgical Products, Inc. · Anti fog solution and accessories, endoscopy1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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