Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (...
FDA Device Recall #Z-0482-2022 — Class II — November 16, 2021
Recall Summary
| Recall Number | Z-0482-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 16, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ohio Medical Corporation |
| Location | Gurnee, IL |
| Product Type | Devices |
| Quantity | 649 portable suction pumps and replacement pumps |
Product Description
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.
Reason for Recall
Increase in premature device failures
Distribution Pattern
US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
Lot / Code Information
Shipped between March 2019 and February 2021.
Other Recalls from Ohio Medical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1980-2025 | Class II | GCE HEALTHCARE Zen-O lite, Portable Oxygen Conc... | May 8, 2025 |
| Z-2995-2018 | Class II | Portable Suction Pump, (a) Style 758010, Model ... | Aug 14, 2018 |
| Z-2410-2018 | Class II | Vacuum Regulator, Push-T-Set Intermittent Sucti... | Mar 12, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.