Z-0482-2022Class II

Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model...

Name: Z-0482-2022 Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model...
Creator: Ohio Medical Corporation
Published: 2021-11-16
License: https://open.fda.gov/license/

Ohio Medical LLC / initiated 2021-11-16 / Open, Classified / root cause: manufacturing process

FDA source

Ohio Medical Corporation began a recall of Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps... on 2021-11-16. FDA classified it as Class II and gives the reason as "Increase in premature device failures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0482-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-16
Posted: 2022-01-11
Recalling firm: Ohio Medical LLC
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.
Product code: BTA Pump, Portable, Aspiration (Manual Or Powered)
Reason for recall: Increase in premature device failures
Root cause tag: manufacturing process
FDA 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 in commerce: 649 portable suction pumps and replacement pumps
Distribution: US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
Product codes and lots: Shipped between March 2019 and February 2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0482-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0482-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-19	2022-01-11

Product code BTA

K933902Class IIMoblvac IIIAeros Instruments, Inc. / cleared 1994-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)