FDA Medical Device Recalls (openFDA)
Ohio Medical Corporation: 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.
- Recall number
- Z-0482-2022
- Recalling firm
- Ohio Medical Corporation
- 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.
- Status
- Open, Classified
- Initiated
- 2021-11-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- Increase in premature device failures
- Root cause
- Employee error
- Action
- The firm notified their consignees by letter beginning 11/16/2021 via USPS. The letter identified the defect and requested the return of the affected devices for testing unless it is not feasible to do so. Consignees were provided an alternative option for on site testing if the device could not be returned.
- Quantity
- 649 portable suction pumps and replacement pumps
- Distribution
- US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
- Lot, serial or model codes
- Shipped between March 2019 and February 2021.
- 510(k) numbers
- ["K933902"]
- PMA numbers
- not on file
- Product code
- BTA
- Firm FEI
- 1419185
- Firm city
- Gurnee
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28