Home › Device types › BZO
Set, Tubing And Support, Ventilator (W Harness)
FDA product code BZO · Class 1 · Anesthesiology
950
Registered devices
1,682
Adverse events
23
Recalls
88
510(k) clearances
Devices with this code
RUSCH — TELEFLEX INCORPORATEDBreathing circuit set, coaxial — Hamilton Medical AGBreath syst 15mm HME & MR 3M Disp — Maquet Critical Care ABAnesthesia Set Coax 230 — Drägerwerk AG & Co. KGaAFLUSSO BY PASS ADAPTER — McArthur Medical Sales IncHose kit adult, Aquapor — Drägerwerk AG & Co. KGaAKC 018-N - 10mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATEDHUDSON RCI — TELEFLEX INCORPORATEDClassic RT — Plastiflex Group NVID Circuit Watertrap (N) 180 — Drägerwerk AG & Co. KGaAAdapters/Connectors — WESTMED, INC.Classic RT — Plastiflex Group NVHUDSON RCI — TELEFLEX INCORPORATEDCuraplex — BOUND TREE MEDICAL, LLCAnesthesia Set Coax 180 (BagCone OD22) — Drägerwerk AG & Co. KGaAINOmax — Mallinckrodt Manufacturing LLCKC 006-BC - 22mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATEDKC 048-P - 15mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATEDFisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE LIMITEDClassic RT — Plastiflex Group NVINOmax — Mallinckrodt Manufacturing LLCAdapters/Connectors — WESTMED, INC.Vent Set Flex — Drägerwerk AG & Co. KGaACreate Biotech — CREATE BIOTECH CO., LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Medline Industries, LP | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discolorat |
| 2026-05-29 | Hamilton Medical AG | Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will |
| 2025-09-17 | Percussionaire Corporation | IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL |
| 2025-06-26 | Hamilton Medical AG | Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory a |
| 2025-03-12 | Draeger, Inc. | The potential for cracks forming in the breathing circuit hose. |
| 2024-08-21 | Percussionaire Corporation | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy. |
| 2024-08-21 | Percussionaire Corporation | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy. |
| 2023-08-08 | Mallinckrodt Manufacturing LLC | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. |
| 2023-04-17 | Draeger Medical, Inc. | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. |
| 2023-04-17 | Draeger Medical, Inc. | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.