FDA Device recall Z-2036-2025

BiPAP A30 Ventilators

FDA Device
Class I
ongoing
Published 2025-07-09

On 2025-07-09 the FDA classified a Class I recall of BiPAP A30 Ventilators by Philips Respironics, citing this device does not indicate for use in patients with respiratory failure.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2036-2025
Classification	Class I
Status	ongoing
Initiated	2025-05-09
Published	2025-07-09
Last updated	2026-09-13 11:57 UTC
Company	Philips Respironics
Distribution	US

Product

BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.

Reason

This device does not indicate for use in patients with respiratory failure.

Identifiers

code_info	BiPAP A30 Part No. 1111143, 1111144, CN1111143, 1111145, 1111147, 1111149, 1111148, 1111150, 1116155, BR1111143, 111114… BiPAP A30 Part No. 1111143, 1111144, CN1111143, 1111145, 1111147, 1111149, 1111148, 1111150, 1116155, BR1111143, 1111144M, 1111144L, 1111144V, R1076491, 1111154, R1111143, 1101109, 1109594, 1076540, 1076581, 1076583, 1076582, 1111145, 1076581, ; UDI: 00606959021532, 00606959039308, 00606959039315, 00606959039339, 00606959039346, 00606959039353, 00606959039360, 00606959039384, 00606959039391, 00606959042728, 00606959048744, 00606959048751, 00606959048768, 00606959067530, 00606959067660, 00606959412675, 00606959412699; Serial No. N09765363D900, N097653668EAD, N097653679F24, N10271255612B, N1027125653B0, N102712632E75, N102712654B43, N1027126679D8, N1027126890A6, N10271275529B, N10271282A5EC, N10271287F241, N102712880AB6, N102712891B3F, N10271294D902, N10271297EB99, N10271298136E, N1027129902E7, N102713122828, N1027131996FB, N1027132576FF, N102713374C35, N10271476B6D9, N10271511CC6A, N10271513EF78, N1027151851AB, N1030722442C7, N1030728875DB, N10307291F1C2, N10307295B7E6, N103072986C03, N

code_info

BiPAP A30 Part No. 1111143, 1111144, CN1111143, 1111145, 1111147, 1111149, 1111148, 1111150, 1116155, BR1111143, 111114…

BiPAP A30 Part No. 1111143, 1111144, CN1111143, 1111145, 1111147, 1111149, 1111148, 1111150, 1116155, BR1111143, 1111144M, 1111144L, 1111144V, R1076491, 1111154, R1111143, 1101109, 1109594, 1076540, 1076581, 1076583, 1076582, 1111145, 1076581, ; UDI: 00606959021532, 00606959039308, 00606959039315, 00606959039339, 00606959039346, 00606959039353, 00606959039360, 00606959039384, 00606959039391, 00606959042728, 00606959048744, 00606959048751, 00606959048768, 00606959067530, 00606959067660, 00606959412675, 00606959412699; Serial No. N09765363D900, N097653668EAD, N097653679F24, N10271255612B, N1027125653B0, N102712632E75, N102712654B43, N1027126679D8, N1027126890A6, N10271275529B, N10271282A5EC, N10271287F241, N102712880AB6, N102712891B3F, N10271294D902, N10271297EB99, N10271298136E, N1027129902E7, N102713122828, N1027131996FB, N1027132576FF, N102713374C35, N10271476B6D9, N10271511CC6A, N10271513EF78, N1027151851AB, N1030722442C7, N1030728875DB, N10307291F1C2, N10307295B7E6, N103072986C03, N

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2036-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.