FDAClass II · Medical device · Recall Z-3257-2026 · Recalled September 30, 2026
Brand Name recall — Baxter Healthcare Corporation
Agency report date: September 30, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: Brand Name recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
More Baxter Healthcare recalls
- Dextrose Injection recall — Baxter Healthcare CorporationFDA · September 16, 2026
- 0 recall — Baxter Healthcare CorporationFDA · September 9, 2026
- Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recall — Baxter Healthcare CorporationFDA · August 19, 2026
- Cefazolin in Dextrose recall — Baxter Healthcare CorporationFDA · August 19, 2026
- Hillrom VOLARA System P recall — Baxter Healthcare CorporationFDA · July 8, 2026
Other medical device recalls from around the same time
- Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED recall — Medline Industries, LPFDA · October 7, 2026
- Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall — Medline Industries, LPFDA · October 7, 2026
- Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall — Boston Scientific CorporationFDA · September 30, 2026
- Halyard IV START KIT NON-STERILE recall — AVID Medical, Inc.FDA · September 30, 2026
- INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recall — CooperSurgical, Inc.FDA · September 30, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.