Vacuum Regulator — Class II medical device recall Z-2410-2018
Terminated recall by Ohio Medical Corporation, reported 2018-07-18, distributed nationwide. Final quality control testing was not completed before the devices were distributed..
| Recall number | Z-2410-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ohio Medical Corporation, Gurnee, IL, United States |
| Recall initiated | 2018-03-12 |
| Classified | 2018-07-10 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 11 units |
| UPC / GTIN / UDI-DI | 08688250002085 |
| Lot numbers | ISU177359 |
| Model numbers | 8701-1251-901, 8701-1251-908, 8702-1251-908, 8705-1251-901, 8705-1251-907 |
Product
Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.
Reason for recall
Final quality control testing was not completed before the devices were distributed..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2410-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.