Medline Industries, Inc. CDS983362CRecalls & reported problems
Medline Industries, Inc. · T AND A CDS · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name 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
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489267341), received between Apr 7, 2024 and Apr 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
2 FDA recall records name this device's identifier, 2 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.
Reports received per month
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-2491-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Nov 15, 2023Class IOpen, Classified
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Z-1101-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2024Crack; Crack
IT WAS REPORTED THAT AN EAR ULCER SYRINGE COMPONENT WAS FOUND TO BE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056786 ↗
Other Ear, nose, and throat surgical tray devices
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- Medline Industries, Inc. DYNJ66509AMedline Industries, Inc. · Ear, nose, and throat surgical tray3 recalls1 report
- Medline Industries, Inc. CDS984899GMedline Industries, Inc. · Ear, nose, and throat surgical tray3 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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