Class I recallOngoing

Welch Allyn, Inc recall — FDA event 95842

FDA · FDA event 95842 · Posted Jan 16, 2025

Published Jan 16, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/20/2024 via USPS first class mail. The notice explained the problem with the device, hazard involved, and requested the following actions be taken: 1. Always have an alternate means of ventilation or oxygen therapy available. 2. Patients may continue using the Life2000 ventilator if it is functioning correctly. If the ventilator becomes inoperable, place the patient on an alternate means of ventilation, if necessary, and contact Baxter Advanced Respiratory, Clinical Support team at 800-397-9071. 3. In the interim if patients experience this failure and have an additional charger available, connect it to the ventilator and verify that the ventilator is charging. 4. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. 6. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to the Director of Respiratory Therapy, Patient Safety, and any other departments within your institution who use the affected product. 7. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal. Durable Medical Equipment providers are required to notify patients of this Urgent Medical Device Correction by forwarding the attached home patient letter.
For general questions regarding this Urgent Medical Device Correction, please contact the Baxter Advanced Respiratory team at 800

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Welch Allyn, Inc by Baxter Healthcare Corporation.

Products affected by FDA event 95842
Model	Description	Lot / serial range	Manufactured	Status
Z-0886-2025	Z-0886-2025	UDI/DI 00887761981638, Serial Numbers: 122010001081	Not provided in the normalized record	Ongoing
Z-0887-2025	Z-0887-2025	UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081	Not provided in the normalized record	Ongoing
Z-0885-2025	Z-0885-2025	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	Not provided in the normalized record	Ongoing
Z-0884-2025	Z-0884-2025	UDI/DI 00887761978201, Serial Numbers: 124080000663, 124020000164, 124020000165, 124020000166, 124020000167, 124020000168, 124020000169, 124020000170, 124020000171, 124020000172, 124020000173, 124020000174, 124020000175, 124020000176, 124080000659, 124080000661, 124080000662, 124080000666, 124080000667, 124080000668, 124080000669, 123420000499, 123490000931, 124010000910, 124020000163, 124080000670, 124080000672, 124080000673, 124080000675, 124080000677, 124080000678, 124080000679, 124080000715, 124080000716, 124080000718, 124080000733, 124080000735, 124080000772, 124080000784, 124080000854, 124080000855, 124080000856, 124080000857, 124080000863, 124080000865, 124080000919, 124080000920, 124080000921, 124080000922, 124080000923, 124080000924, 124080000925, 124080000926, 124080001290, 124080001367, 124080001388, 124080001409, 124080001594, 124080001596, 124080001601, 124080001602, 124080001603, 124080001604, 124080001605, 124080001606, 124080001608, 124080001609, 124080001610, 12408000	Not provided in the normalized record	Ongoing

Distribution: US, Nationwide Distribution
Units affected: See official FDA record
Category: Ventilators

Timeline

Dec 20, 2024
Recall initiated
Date recorded by the FDA.
Jan 16, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 95842
Published: Jan 16, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

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Loading MedWatcher information…

Welch Allyn, Inc recall — FDA event 95842

FDA · FDA event 95842 · Posted Jan 16, 2025

Published Jan 16, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

Products affected by FDA event 95842
Model	Description	Lot / serial range	Manufactured	Status
Z-0886-2025	Z-0886-2025	UDI/DI 00887761981638, Serial Numbers: 122010001081	Not provided in the normalized record	Ongoing
Z-0887-2025	Z-0887-2025	UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081	Not provided in the normalized record	Ongoing
Z-0885-2025	Z-0885-2025	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	Not provided in the normalized record	Ongoing
Z-0884-2025	Z-0884-2025	UDI/DI 00887761978201, Serial Numbers: 124080000663, 124020000164, 124020000165, 124020000166, 124020000167, 124020000168, 124020000169, 124020000170, 124020000171, 124020000172, 124020000173, 124020000174, 124020000175, 124020000176, 124080000659, 124080000661, 124080000662, 124080000666, 124080000667, 124080000668, 124080000669, 123420000499, 123490000931, 124010000910, 124020000163, 124080000670, 124080000672, 124080000673, 124080000675, 124080000677, 124080000678, 124080000679, 124080000715, 124080000716, 124080000718, 124080000733, 124080000735, 124080000772, 124080000784, 124080000854, 124080000855, 124080000856, 124080000857, 124080000863, 124080000865, 124080000919, 124080000920, 124080000921, 124080000922, 124080000923, 124080000924, 124080000925, 124080000926, 124080001290, 124080001367, 124080001388, 124080001409, 124080001594, 124080001596, 124080001601, 124080001602, 124080001603, 124080001604, 124080001605, 124080001606, 124080001608, 124080001609, 124080001610, 12408000	Not provided in the normalized record	Ongoing

Distribution

US, Nationwide Distribution

Units affected

See official FDA record

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

FDA · FDA event 98888Posted Jun 23, 2026

Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554Posted May 1, 2026

Welch Allyn, Inc recall — FDA event 95842

Follow Welch Allyn, Inc

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Welch Allyn, Inc recall — FDA event 95842

Follow Welch Allyn, Inc

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline