Lower riskMedical device recall · FDA · Published March 12, 2018
Ohio Medical Corp Recalls Vacuum Regulator for Incomplete Quality Testing
Ohio Medical Corporation recalls vacuum regulators for incomplete quality control testing. Affected units have specific model numbers and lot numbers. Consumers should contact the company for details.
“Ohio Medical Corp Recalls Vacuum Regulator for Incomplete Quality Testing.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71737-ohio-medical-corp-recalls-vacuum-regulator-for-incomplete-quality-testing. Based on FDA recall #Z-2410-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2410-2018%22&limit=1).
The Food and Drug Administration announced on March 12, 2018, that Ohio Medical Corporation voluntarily recalled Vacuum Regulator, Push-T-Set Intermittent Suction Units (PTS-ISU) because final quality control testing was not completed before distribution. The agency classified the recall as Class II.
How to tell if you have it
Brand: Ohio Medical Corporation
Product: Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU)
Distribution: US Nationwide in NC, IN, TN, LA, FL, MI, IL
The hazard
The recall was issued because final quality control testing was not completed before the devices were distributed. The vacuum regulator is intended to be used in a medical facility as a means to evacuate media from the body.
Context
GovInfoNow's records show Ohio Medical Corporation has had three other recalls since August 14, 2018. Other recent recalls of similar products include GCE HEALTHCARE Zen-O lite Oxygen Concentrator Recall (May 8, 2025), Instavac Portable Suction Pump Recall (November 16, 2021), and Ohio Medical CARE-E-VAC 3 Portable Suction Pump Recall (August 14, 2018). Other recent recalls of similar products include 3B Medical React Health PHOENIX 5L Oxygen Concentrator Recall (February 4, 2026), Medline Recalls Control Syringes and Manifold Kits Due to Regulatory Clearance Rescinded (February 25, 2026), and Stryker FluidSmart Urology Tube Set Recall (April 9, 2026).
How to tell if you have this one
Check for model numbers 8702-1251-908, 8701-1251-901, 8705-1251-907, 8701-1251-908, 8705-1251-901. Also look for lot number ISU177359 or device unit numbers listed in the recall notice.
Brand
Ohio Medical Corporation
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Ohio Medical Corporation for specific instructions on how to verify your unit and get replacement or repair options.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Illinois, Indiana, Louisiana, Michigan, North Carolina, Tennessee.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2410-2018 (March 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2410-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.