Medline DYND18350Recalls & reported problems
Medline Industries, Inc. · TRAY,URETHRAL,CATHETER,RED-RUBBER,15FR · Class 2
Data updated Oct 18, 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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 18, 2026.
Recalls naming this device
- May 4, 2026Class IIOpen, Classified
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2482-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Catheter care tray devices
- Centurion Medical Products Corp CVI680CMedline Industries, Inc. · Catheter care tray2 recalls0 reports
- Medline Industries, Inc. DYNJ81597Medline Industries, Inc. · Catheter care tray2 recalls0 reports
- Bardia® Foley Catheter Insertion Tray 802010C. R. Bard, Inc. · Catheter care tray54 reports
- Medline DYND10160Medline Industries, Inc. · Catheter care tray1 recall4 reports
- Medline DYNC1816Medline Industries, Inc. · Catheter care tray1 recall2 reports
- SureStep Intermittent Catheter Tray INTAAIC. R. Bard, Inc. · Catheter care tray1 recall1 report
- Medline DYND10407Medline Industries, Inc. · Catheter care tray1 recall1 report
- MEDLINE URO4RR16CMedline Industries, Inc. · Catheter care tray1 recall0 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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