Medline DYNJP4124Recalls & reported problems
Medline Industries, Inc. · DRAPE, RADIAL FEMORAL · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196164943), received between Sep 3, 2026 and Sep 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Fluid/Blood Leak
It was reported that "They are now made out of a non absorbent material and blood goes everywhere.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757581 ↗MalfunctionSep 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595708 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page