Medline DYNJP6108Recalls & reported problems
Medline Industries, Inc. · DRAPE,C-SECTION,FEN,CLR SCREEN,WIRE,7/CS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277668843), received between Jun 17, 2026 and Jun 17, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Adhesive Too Strong” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Feb 13, 2025Open, Classified
Potential breach in pouch packaging which could lead to loss of sterility.
Z-1363-2025 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adhesive Too Strong1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Material Split, Cut or Torn; Adhesive Too Strong
IT WAS REPORTED THAT THE CLEAR SCREEN IS COMING APART AT THE DRAPE, EXPOSING PATIENT AND BREAKING STERILITY. INCISE ADHESION IS HARDER TO REMOVE FROM PATIENT SKIN.
Patient problems: Insufficient Information
MAUDE report 25540706 ↗
Other Drape, surgical, exempt devices
- Medline DYNJP3102AMedline Industries, Inc. · Drape, surgical, exempt3 recalls2 reports
- Medline DYNJP2498Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls1 report
- Medline DYNJP8005UGMedline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP3103Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP8304AMedline Industries, Inc. · Drape, surgical, exempt3 recalls0 reports
- Medline DYNJP9103Medline Industries, Inc. · Drape, surgical, exempt2 recalls7 reports
- Medline DYNJP8201Medline Industries, Inc. · Drape, surgical, exempt2 recalls6 reports
- Medline DYNJP6006Medline Industries, Inc. · Drape, surgical, exempt2 recalls4 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 · each recall links to the FDA recall notice
- 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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