MEDLINE INDUSTRIES, INC. OR61Recalls & reported problems
Medline Industries, Inc. · YANKAUER,FLEXIBLE HANDLE,REGLR CAPACITY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884389100011), received between Jan 22, 2025 and Sep 15, 2026 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (1 report).
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
Most reported problems
Device problems
- Connection Problem1
- Fitting Problem1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Aspiration/Inhalation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777154 ↗MalfunctionSep 8, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676345 ↗DeathJan 22, 2025Connection Problem; Connection Problem
ACCORDING TO THE FACILITY ON (B)(6) 2024 THERE WAS A DELAY IN SUCTIONING THE PATIENT AS THE YANKAUER WOULDN'T "PROPERLY CONNECT TO THE SUCTION TUBING".
Patient problems: Aspiration/Inhalation
MAUDE report 21211647 ↗
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- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
- Aqua-Seal 8888571406Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Altitude 8888571370Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- CRD 65651-517Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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