The Recall Desk
ModerateFDA (Devices)·Z-0482-2022·Announced 2022-01-19

Instavac Portable Suction Pumps Recalled for Premature Device Failures

Ohio Medical Corporation is recalling Instavac Portable Suction Pumps (models 757000, 756000, and replacement pump part #AI5511) due to an increase in premature device failures. Affected units were distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported hospitalizations or injuries. The hazard involves premature device failures, a functional defect warranting precautionary action.

Plain-English summary

Ohio Medical Corporation is recalling Instavac Portable Suction Pumps due to an increase in premature device failures. The recall includes model #757000 (Constant mode, Instavac C), model #756000 (Intermittent mode, Instavac I), and replacement pump part #AI5511. Approximately 649 portable suction pumps and replacement pumps are affected.

The affected pumps were shipped between March 2019 and February 2021. The reason for the recall is an increase in premature device failures of these devices.

The recalled pumps were distributed nationwide in the United States, including Puerto Rico. They were also distributed to government and foreign locations, but not to military locations. Consumers who have these pumps should contact Ohio Medical Corporation for further instructions regarding this Class II recall.

The recalled product

Product
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.
Manufacturer
Ohio Medical Corporation
Hazard
  • premature-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Shipped between March 2019 and February 2021.

Distribution

Distributed nationwide across the United States.