FDAClass IRecall started September 17, 2026

VOCSN (PRT-01100-000) Recall

VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was VOCSN recalled?

Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.

Which lot codes, UPCs or models are affected?

All Serial Numbers: UDI: 00855573007747

Agency record number
Z-0126-2027
Product
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Recalling firm
Ventec Life Systems, Inc.
Quantity
1,532 units
Distribution
Distribution US nationwide including Puerto Rico.
Recall started
September 17, 2026
Report date
October 28, 2026
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls