Food, drugs, devices › Ohio Medical Corporation
Device recall: Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac
Ohio Medical Corporation (Gurnee, IL) initiated this device recall on 16 Nov 2021; FDA lists 1 product record under event 88984, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Ohio Medical Corporation has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ohio Medical Corporation, Gurnee, IL.
Reason for recall
"Increase in premature device failures"
Distribution
"US Nationwide, including PR. There was government and foreign distribution. There was no military distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0482-2022 | Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000. | 649 portable suction pumps and replacement pumps | Class II | Ongoing | 19 Jan 2022 |
Context
Other enforcement events for Ohio Medical Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 May 2025 | GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S | Device | Class II | 1 |
| 14 Aug 2018 | Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohi | Device | Class II | 1 |
| 12 Mar 2018 | Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be u | Device | Class II | 1 |
All 4 events for Ohio Medical Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Increase in premature device failures"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide, including PR. There was government and foreign distribution. There was no military distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.