FDA Device recall Z-0885-2025

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

FDA Device
Class I
ongoing
Published 2025-01-22

On 2025-01-22 the FDA classified a Class I recall of Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A by Baxter Healthcare, citing there is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0885-2025
Classification	Class I
Status	ongoing
Initiated	2024-12-20
Published	2025-01-22
Last updated	2026-09-13 11:57 UTC
Company	Baxter Healthcare
Distribution	US

Product

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

Reason

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

Identifiers

code_info	UDI/DI 00887761981638, Serial Numbers: L1903102-017, L1911019-025, L2001042-007, L2001042-016, L2003015-264, L2005055-… UDI/DI 00887761981638, Serial Numbers: L1903102-017, L1911019-025, L2001042-007, L2001042-016, L2003015-264, L2005055-916, L2006020-163, L2006020-265, L2006020-455, L2006020-499, L2006020-548, L2007003-009, 120190000085, 120190000090, 120190000707, 120190000713, 120190000714, 120190000730, 120210000714, 120210000719, 120210000740, 120210000744, 120210000756, 120210000759, 120210000760, 120210000884, 120210001610, 120270001439, 120270001446, 120270001452, 120270001453, 120270001455, 120270001469, 120270001478, 120280000212, 120280000218, 120280000241, 120280000248, 120280000341, 120280000347, 120280000349, 120280000354, 120280000356, 120280000360, 120280000364, 120280000368, 120280000369, 120280000376, 120280000380, 120280000850, 120280000851, 120280000864, 120280000873, 120280000880, 120280000975, 120280000977, 120280000978, 120280000979, 120280000989, 120290000531, 120290000536, 120290000550, 120290000607, 120290000615, 120290000629, 120290000630, 120290000650, 120290001090, 12029000

code_info

UDI/DI 00887761981638, Serial Numbers: L1903102-017, L1911019-025, L2001042-007, L2001042-016, L2003015-264, L2005055-…

UDI/DI 00887761981638, Serial Numbers: L1903102-017, L1911019-025, L2001042-007, L2001042-016, L2003015-264, L2005055-916, L2006020-163, L2006020-265, L2006020-455, L2006020-499, L2006020-548, L2007003-009, 120190000085, 120190000090, 120190000707, 120190000713, 120190000714, 120190000730, 120210000714, 120210000719, 120210000740, 120210000744, 120210000756, 120210000759, 120210000760, 120210000884, 120210001610, 120270001439, 120270001446, 120270001452, 120270001453, 120270001455, 120270001469, 120270001478, 120280000212, 120280000218, 120280000241, 120280000248, 120280000341, 120280000347, 120280000349, 120280000354, 120280000356, 120280000360, 120280000364, 120280000368, 120280000369, 120280000376, 120280000380, 120280000850, 120280000851, 120280000864, 120280000873, 120280000880, 120280000975, 120280000977, 120280000978, 120280000979, 120280000989, 120290000531, 120290000536, 120290000550, 120290000607, 120290000615, 120290000629, 120290000630, 120290000650, 120290001090, 12029000

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-0885-2025%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.