Medline DYND12200Recalls & reported problems
Medline Industries, Inc. · PLUG,CATHETER,DRAINAGE PROTECTOR,TUBE · Class 1
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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196030873), received between May 9, 2024 and May 7, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1610-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Leak/Splash
PER EMAIL, DOCTOR WAS TRYING TO USE THE CAP DURING A CASE REQUIRING CHEMO MEDICATION TO BE INSERTED INTO THE BLADDER. AFTER THE MEDICATION WAS PLACED IN THE PATIENT, THE DOCTOR EXPRESSED TO ME THAT HE HAD QUITE A LOT OF DIFFICULTY ATTEMPTING TO PUT THE CAP IN THE FOLEY CATHETER. HE SAID THAT CHEMO MEDICATION WAS LEAKING AROUND THE CAP ALSO.
Patient problems: Insufficient Information
MAUDE report 25116642 ↗InjuryMay 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
Other CONNECTOR, CATHETER devices
- Cook G02278Cook Incorporated · CONNECTOR, CATHETER1 recall7 reports
- Cook G02791Cook Incorporated · CONNECTOR, CATHETER1 recall2 reports
- Cook G02327Cook Incorporated · CONNECTOR, CATHETER1 recall1 report
- Cook G02898Cook Incorporated · CONNECTOR, CATHETER1 recall0 reports
- Cook G02464Cook Incorporated · CONNECTOR, CATHETER1 recall0 reports
- CARDINAL HEALTH SU130-4601Cardinal Health 200, LLC · CONNECTOR, CATHETER1 recall0 reports
- Medline DYND2219Medline Industries, Inc. · CONNECTOR, CATHETER1 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 · 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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