Protek 1-519-3230CIRecalls & reported problems
Aspen Surgical Products, Inc. · Cone; Endocavity Probe Cover; 3.5cm x 20cm; Latex; rolled; 4 bands; sterile; 1/pouch; 40/box; (934412) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 60841912100882), received between May 13, 2026 and May 13, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Perforation” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Perforation1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Material Puncture/Hole; Material Perforation
COMPLAINANT ALLEGES "THE ITEM # IS 934412 AND OUR CLINICAL STAFF HAS BEEN FINDING HOLES IN THEM WHEN THEY PUT THE PROBE COVER OVER THE PROBE. YOU CAN'T SEE THE HOLES UNTIL THE COVER IS STRETCHED OUT, IF THAT MAKES SENSE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164579 ↗
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- Medline DYNJP2411Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP8002Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP3008UGMedline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP2416Medline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP4003Medline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline DYNJP2418Medline Industries, Inc. · Drape, surgical2 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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