Medline Anti-Fog, Sterile MD-1001ERecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840113214822), received between Aug 13, 2025 and Dec 23, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Optical Obstruction” (2 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
- Optical Obstruction2
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Optical Obstruction; Optical Obstruction
COMPLAINANT ALLEGES "PRODUCT APPEARS TO BE LESS EFFECTIVE, RESULTING IN BLURRED IMAGES DURING LAPAROSCOPIC PROCEDURES. THIS PROBLEM HAS OCCURRED TWICE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878621 ↗MalfunctionOct 28, 2025Optical Obstruction; Optical Obstruction
COMPLAINANT ALLEGES "WHEN USED ON THE SPONGE, THE ANTI-FOGGING AGENT FOAMS UP, WHICH ACTUALLY REDUCES VISIBILITY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402678 ↗MalfunctionAug 13, 2025Unsealed Device Packaging; Unsealed Device Packaging
COMPLAINANT ALLEGES "ISSUE IS THE PACKAGING IS NOT CORRECTLY PERFORATED AND THEN SEPARATED TO WHERE MULTIPLES ARE STILL TOGETHER AND NOT IN THEIR INDIVIDUAL PACKAGE FORM." AFTER REVIEW OF PICTURES, IT WAS DETERMINED THAT THE PERFORATION MAY INTERFERE WITH THE STERILITY SEAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22796273 ↗
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
- Dr. Fog® Treated Sponge DF-3120Aspen Surgical Products, Inc. · Anti fog solution and accessories, endoscopy11 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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