Severity
Moderate
FDA Devices recall · Reported January 19, 2022
Increase in premature device failures
Ohio Medical Corporation recalled Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermitten… - a moderate-severity action.
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermitten… was recalled by Ohio Medical Corporation in January 19, 2022. Reason: Increase in premature device failures. Check the official notice for the remedy. Verify recall #Z-0482-2022 with the FDA Devices before acting.
The recall
Ohio Medical Corporation issued this moderate-severity FDA Devices recall-Increase in premature device failures.
Sourced from official FDA Devices enforcement records. Verify recall #Z-0482-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0482-2022) was formally reported on January 19, 2022, with the manufacturer initiating the action on November 16, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ohio Medical Corporation is listed as the recalling firm, operating out of Gurnee, IL. Federal records list the affected scope as 649 portable suction pumps and replacement pumps.
The documented reason for this recall is: Increase in premature device failures Distribution data in the federal record shows the product reached: US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
649 portable suction pumps and replacement pumps
Related Recalls
6
3 from same agency
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.
Increase in premature device failures
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0482-2022 |
| Date reported | January 19, 2022 |
| Date initiated | November 16, 2021 |
| Recalling firm | Ohio Medical Corporation |
| Firm location | Gurnee, IL |
| Affected scope | 649 portable suction pumps and replacement pumps |
| Distribution | US Nationwide, including PR. There was government and foreign distribution. There was no military distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 19, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.