Medline DYNJP4105Recalls & reported problems
Medline Industries, Inc. · DRAPE,PROCEDURE,SPECIAL,STERILE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10080196736362), received between Aug 31, 2026 and Sep 29, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (7 reports).
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
- Nonstandard Device7
- Adhesive Too Strong1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934372 ↗MalfunctionSep 3, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590758 ↗MalfunctionSep 3, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589955 ↗MalfunctionSep 3, 2026Adhesive Too Strong
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50587005 ↗MalfunctionSep 2, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564747 ↗MalfunctionSep 1, 2026Nonstandard Device
It was reported that "There is no adhesive on the drape other than the part that covers the actual opening of the drape. The drape should have an open hole with adhesive around the hole."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545175 ↗MalfunctionSep 1, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50540671 ↗MalfunctionAug 31, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50527123 ↗
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
- 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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