Ohio Medical Vacuum RegulatorRecalls & reported problems across all models
Ohio Medical, LLC · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Ohio Medical Vacuum Regulator by Ohio Medical, LLC in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Feb 18, 2025 and Sep 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (1 report).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Ohio Medical Vacuum Regulator recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 Ohio Medical Vacuum Regulator problems
Device problems
- Suction Failure1
- Suction Problem1
- Unexpected Therapeutic Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Ohio Medical Vacuum Regulator models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ohio Medical Vacuum Regulator PISARegulator, Vacuum1 recall2 reports
- Ohio Medical Vacuum Regulator PISARegulator, Vacuum1 report
Recent Ohio Medical Vacuum Regulator adverse event reports
The 3 most recent reports across all models, 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 ↗MalfunctionSep 24, 2026Suction Failure
Medsun report (b)(4) was received and complaint case (b)(4) was initiated.Medsun description was as follows: Vacuum Regulator, had selector switch to set to intermittent suction section setting. Observed regulator not releasing suction.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881877 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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