Dr. Fog® Treated Sponge DF-3120Recalls & reported problems
Aspen Surgical Products, Inc. · Intended to be used as an anti-fog agent for endoscopic camera lenses · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840113206926), received between Oct 25, 2024 and May 29, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (11 reports).
2 other recalls cover devices cleared under the same FDA submission (K932449); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unsealed Device Packaging11
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZED FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25337888 ↗MalfunctionMay 7, 2026Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZED SEAL FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117031 ↗MalfunctionMar 31, 2026Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZED FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746675 ↗MalfunctionMar 3, 2026Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZED SEAL FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496539 ↗MalfunctionDec 12, 2025Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZED FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796410 ↗MalfunctionOct 28, 2025Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZED FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23403875 ↗MalfunctionAug 27, 2025Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZED FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22906049 ↗MalfunctionJul 1, 2025Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZATION FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375635 ↗MalfunctionMay 29, 2025Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZATION FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109848 ↗MalfunctionMar 27, 2025Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZED FAILURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710432 ↗MalfunctionOct 25, 2024Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "STERILIZATION BREACH, AS SEAL WAS OPEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20532774 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K932449. One submission often covers many models, so check the product and lot details in each record.
Other Anti fog solution and accessories, endoscopy devices
- Medline Anti-Fog, Sterile MD-1001EAspen Surgical Products, Inc. · Anti fog solution and accessories, endoscopy3 reports
- DeRoyal 28-0101BDeroyal Industries, Inc. · Anti fog solution and accessories, endoscopy2 reports
- ClearIt Anti-Fog Kit PS003Preservation Solutions Inc · Anti Fog Solution And Accessories, Endoscopy1 report
- Dr. Fog® Solution With Sponge DF-3100Aspen Surgical Products, Inc. · Anti fog solution and accessories, endoscopy1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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