Baxter Healthcare Corporation medical device recall: Welch Allyn
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 95842
- Recall initiated
- Dec 20, 2024
- Classified by FDA
- Jan 16, 2025
- Posted in Enforcement Report
- Jan 22, 2025
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 4
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Dec 20, 2024. FDA classified it 27 days later, on Jan 16, 2025. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: US, Nationwide Distribution Baxter Healthcare Corporation has 279 recalls in our records.
Recalled products (4)
Z-0884-2025 Class I Ongoing
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Codes / lots: 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,…
Quantity: 187 units
Z-0885-2025 Class I Ongoing
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
Codes / lots: 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,…
Quantity: 946 units
Z-0886-2025 Class I Ongoing
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Codes / lots: UDI/DI 00887761981638, Serial Numbers: 122010001081
Quantity: 1 unit
Z-0887-2025 Class I Ongoing
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Codes / lots: UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081
Quantity: 1 unit
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 95842
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.