Ohio Medical Vacuum Regulator PISA (UDI 08688250002085)Recalls & reported problems
Ohio Medical, LLC · Vacuum Regulator, Push to Set, Intermittent, 200mmHg Analog · Class 2
All models of Ohio Medical Vacuum Regulator (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 08688250002085), received between Feb 18, 2025 and Sep 25, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (1 report).
1 FDA recall record name this device's identifier.
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
- Mar 12, 2018Class IITerminated
Final quality control testing was not completed before the devices were distributed..
Z-2410-2018 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Suction Problem1
- Unexpected Therapeutic Results1
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 25, 2026Suction Problem
Complaint case (b)(4) was initiated due to MedSun report being received (b)(4) stating the following:Describe the event or problem: Suction head was found to be on the high setting. Suction was not working on low setting, attempted to fix. Suction head either to be set at none or high/full. Switched with 5 other suction heads with similar issues. What was the original intended procedure? Suction delivery at low setting. What problem did the use have? Device failed (e.g. broke, couldn't get it or work or stopped working).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901700 ↗MalfunctionFeb 18, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
USER FACILITY REPORT (B)(4) WAS RECEIVED AND CASE WAS INITIATED ON (B)(6) 2024 STATING "VACUUM REGULATOR NOT ADJUSTING APPROPRIATELY. GOES TO FULL VACUUM WHEN IT APPEARS TO BE SET TO LOW."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21393218 ↗
Other Regulator, Vacuum devices
- Medline RTACIBOMMedline Industries, Inc. · REGULATOR, VACUUM7 reports
- Medline RTACIDCMMedline Industries, Inc. · REGULATOR, VACUUM6 reports
- Medline RTACIAAAMedline Industries, Inc. · REGULATOR, VACUUM5 reports
- Medline RTACIBCMMedline Industries, Inc. · REGULATOR, VACUUM2 reports
- Medline RTACIVCMMedline Industries, Inc. · REGULATOR, VACUUM2 reports
- Medline RTACIBOMYMedline Industries, Inc. · REGULATOR, VACUUM2 reports
- Amvex Vacuum Regulator PIDOhio Medical, LLC · Regulator, Vacuum1 report
- Medline RTACIBPBMedline Industries, Inc. · REGULATOR, VACUUM1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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