FDAFDA recall Z-2525-2026 · Jul 1, 2026
Ventec Life Systems, Inc.: VOCSN+Pro package recall
Recall found
Product
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Reason for recall
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
- Quantity
- 1
- Distribution
- US Nationwide distribution in the state of UT.
- Recalling firm
- Ventec Life Systems, Inc., Bothell, WA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-08
Source: openFDA enforcement record Z-2525-2026 · search recall number Z-2525-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.