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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95842

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 20, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

Z-0884-2025
Recall number
Z-0884-2025
Initiated
December 20, 2024
Classification
Class I
Status
Ongoing
Quantity
187 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 124080001612, 124080001614, 124140000062, 124140000063, 124140000065, 124140000067, 124140000068, 124140000069, 124140000070, 124140000123, 124140000125, 124140000126, 124140000127, 124140000401, 124140000402, 124140000403, 124140000404, 124140000405, 124140000636, 124140000637, 124140000638, 124140000668, 124140000671, 124140000672, 124140000675, 124140000677, 124140000679, 124140000681, 124140000683, 124140000684, 124140000686, 124140000687, 124140000688, 124140001005, 124140001014, 124140001187, 124140001191, 124140001195, 124140001201, 124140001203, 124160001584, 124170000747, 124170000749, 124170000804, 124170000828, 124170000832, 124170001158, 124170001159, 124170001161, 124170001162, 124170001163, 124170001166, 124170001171, 124170001172, 124200000070, 124200000071, 124200000072, 124200000073, 124200000074, 124200000076, 124200000077, 124200000078, 124200000079, 124200000080, 124200000081, 124200000083, 124200000084, 124200002473, 124200002474, 124200002475, 124200002476, 124200002478, 124200002479, 124200002480, 124200002481, 124200002482, 124200002485, 124200002486, 124200002489, 124200002490, 124200002491, 124200002492, 124200002493, 124200002494, 124200002495, 124200002496, 124200002497, 124200002498, 124200002499, 124200002500, 124200002501, 124200002502, 124200002503, 124200002504, 124200002505, 124200002506, 124200002507, 124200002508, 124200002509, 124250000491, 124250000492, 124250000493, 124250000494, 124250000495, 124250000496, 124250000497, 124250000498, 124250000499, 124250000500, 124250000533, 124250000534, 124250000535, 124250000536, 124250000537, 124250000538, 124260000558, 124260001171, 124280000585, 124280000741.

Distribution pattern

US, Nationwide Distribution

device · product 2 of 4

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

Z-0885-2025
Recall number
Z-0885-2025
Initiated
December 20, 2024
Classification
Class I
Status
Ongoing
Quantity
946 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 120290001096, 120290001098, 120290001109, 120290001113, 120290001195, 120290001199, 120300000033, 120300000036, 120300000038, 120300000041, 120300000043, 120300000051, 120300000056, 120300000058, 120300000060, 120300000064, 120300000065, 120300000071, 120300000073, 120300000075, 120300000077, 120300000387, 120300000588, 120300000593, 120300000598, 120300000607, 120300000609, 120300000612, 120300000613, 120300000614, 120300000641, 120300000645, 120300000646, 120300000847, 120300000848, 120300000851, 120300000855, 120300000856, 120300000857, 120300000858, 120300000859, 120300000865, 120310000648, 120310000652, 120310000655, 120310000656, 120310000664, 120310000665, 120310000668, 120310000680, 120310000686, 120310000687, 120310000690, 120310000700, 120310000702, 120310000711, 120310000714, 120310000715, 120310000716, 120310000724, 120310000727, 120310000733, 120310000734, 120310000735, 120310000745, 120310001014, 120310001015, 120310001016, 120310001018, 120310001019, 120310001021, 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120360000064, 120360000069, 120360000070, 120360000080, 120360000081, 120360000085, 120360000109, 120360000112, 120360000113, 120360000117, 120360000477, 120360000491, 120360000492, 120360000497, 120360000581, 120360000583, 120360000592, 120360000992, 120360000994, 120360000996, 120360001078, 120360001080, 120360001081, 120360001086, 120360001089, 120360001090, 120360001171, 120360001175, 120360001180, 120360001181, 120360001182, 120360001183, 120360001186, 120360001248, 120360001256, 120360001262, 120360001263, 120360001265, 120360001266, 120360001327, 120360001345, 120370000005, 120370000006, 120370000012, 120370000020, 120370000021, 120370000025, 120370000030, 120370000035, 120370000036, 120370000048, 120370000049, 120370000056, 120370000059, 120370000061, 120370000065, 120370000068, 120370000077, 120370000381, 120370000383, 120370000386, 120370000391, 120370000401, 120370000405, 120370001161, 120370001165, 120370001167, 120370001169, 120370001174, 120370001517, 120370001519, 120370001522, 120370001523, 120370001529, 120370001530, 120370001532, 120370001536, 120370001537, 120370001971, 120370001978, 120370001979, 120370001984, 120370001999, 120370002002, 120370002003, 120370002027, 120370002033, 120370002035, 120370002039, 120370002090, 120370002092, 120370002094, 120370002100, 120370002101, 120370002102, 120370002109, 120380000281, 120380000292, 120380000300, 120380000301, 120380000473, 120380000530, 120380000532, 120380000635, 120380000640, 120380000641, 120380000642, 120380000662, 120380000944, 120380000951, 120380001165, 120380001170, 120380001185, 120380001309, 120380001311, 120380001313, 120380001318, 120380001325, 120380001326, 120380001327, 120380001330, 120380001603, 120380001605, 120380001606, 120380001608, 120380001612, 120380001621, 120380001660, 120380001663, 120380001671, 120380001679, 120390000074, 120390000080, 120390000084, 120390000097, 120390000105, 120390000774, 120390000778, 120390000780, 120390000785, 120390000787, 120390000789, 120390000792, 120390000794, 120390000800, 120390000801, 120390000805, 120390000806, 120390000811, 120390001379, 120390001380, 120390001384, 120390001389, 120390001390, 120390001391, 120390001392, 120390001398, 120390001400, 120390001405, 120390001418, 120390001420, 120390001848, 120390001850, 120390001852, 120390001855, 120390001859, 120390001861, 120390001863, 120390001866, 120390001868, 120390001870, 120390001872, 120390001883, 120390001894, 120390001895, 120400000021, 120400000028, 120400000036, 120400000046, 120400000054, 120400001103, 120400001112, 120400001113, 120400001117, 120400001120, 120400001124, 120400001125, 120400001126, 120400001127, 120400001141, 120400001564, 120400001565, 120400001572, 120400001577, 120400001580, 120400001604, 120400001722, 120400001723, 120400001726, 120400001731, 120400001736, 120400001747, 120400001754, 120400001755, 120400001756, 120420001247, 120420001255, 120420001284, 120420001288, 120420001387, 120420001395, 120420001396, 120420001397, 120420001400, 120420001402, 120420001404, 120420001405, 120420001409, 120420001814, 120420001816, 120420001818, 120420001823, 120420001853, 120430000104, 120430000109, 120430000110, 120430000112, 120430000114, 120430000516, 120430000525, 120430000530, 120430000545, 120430000547, 120430000548, 120430000557, 120430000562, 120430000568, 120430001320, 120430001323, 120430001325, 120430001327, 120430001355, 120430001378, 120450000565, 120450000573, 120450000586, 120450001324, 120450001333, 120460001863, 120460001865, 120460001875, 120460001878, 120460001879, 120460001886, 120460002068, 120460002075, 120460002082, 120460002084, 120460002423, 120460002427, 120460002433, 120460002882, 120460002887, 120460002888, 120460002905, 120470000134, 120470000143, 120470000183, 120470000188, 120470000202, 120470000425, 120470000428, 120470000429, 120470000566, 120470000576, 120470000589, 120500000196, 120500000208, 120500000215, 120500001954, 120500001957, 120500001963, 120500001971, 120510002291, 120510002295, 120510002306, 120530000417, 121010000221, 121010000276, 121010000283, 121010000289, 121010000297, 121010000305, 121020000137, 121020000142, 121020000149, 121020000217, 121020000218, 121020000295, 121020000359, 121020000395, 121020000399, 121200002001, 121200002002, 121410000504, 121410000642, 121410000645, 121410000822, 121410001192, 121490000657, 121490000666, 121490000667, 121490000748, 121490000804, 121490000874, 121500000117, 121500000160, 121500000327, 121500000328, 121500000611, 121500001020, 121500001129, 121500001134, 121500001137, 121500001307, 121500001565, 121510000325, 121510000327, 121510000354, 121510000357, 121510000668, 121520000042, 121520000049, 121520000114, 121520000231, 121520000233, 121520000234, 121520000401, 121520000999, 121520001349, 122010000020, 122010000034, 122010000035, 122010000999, 122010001067, 122010001070, 122010001071, 122050000955, 122050001028, 122050001175, 122050001179, 122050001186, 122050001197, 122050001203, 122060001466, 122060001816, 122060001826, 122060001829, 122060002087, 122060002161, 122070000136, 122070000144, 122070000147, 122070000157, 122070000186, 122080000929, 122090001080, 122090001086, 122090001092, 122090001411, 122090001414, 122090001438, 122100000760, 122100000761, 122100000762, 122100000764, 122100000768, 122100000773, 122100000781, 122100000789, 122100000796, 122100000800, 122100000802, 122100001445, 122100001448, 122100001533, 122110001041, 122110001045, 122110001046, 122110001690, 122110001694, 122110001699, 122110001701, 122120000375, 122120000380, 122120000381, 122120001734, 122130000283, 122150000337, 122150000339, 122150000701, 122150000703, 122150000707, 122150000710, 122150000714, 122270000402, 122270000477, 122270000486, 122270000652, 122270000659, 122270000665, 122270001035, 122270001046, 122270001048, 122270001250, 122270001337, 122280000638, 122280000736, 122280000738, 122280001094, 122280001095, 122280001099, 122280001106, 122280001107, 122280001111, 122280001114, 122280001115, 122280001253, 122280001258, 122280001260, 122280001262, 122280001347, 122280001352, 122290000392, 122290000394, 122340000119, 122340000123, 122340000144, 122340000146, 122340000295, 122340000364, 122340000369, 122340000374, 122340000376, 122340000383, 122340000387, 122340000388, 122340000466, 122340000506, 122340000527, 122340000528, 122340000530, 122340000752, 122340000753, 122340000765, 122340001133, 122340001189, 122340001289, 122340001293, 122340001670, 122340001675, 122340001737, 122340001740, 122340001742, 122340001744, 122340001747, 122410000232, 122410000234, 122410000239, 122410000241, 122410000290, 122410000386, 122410000850, 122410000886, 122410000890, 122410000900, 122410001182, 122410001233, 122410001273, 122410001388, 122410001727, 122410001734, 122410001736, 122480000118, 122480000386, 122480001096, 122480001097, 122480002208, 122480002269, 122480002368, 123010001080, 123010001093, 123010001094, 123010001095, 123010001126, 123010001141, 123010001144, 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123140000137, 123140000502, 123140000666, 123160000214, 123160000216, 123160000219, 123160000481, 123160000482, 123160000483, 123160000487, 123160000488, 123160000522, 123160000526, 123160000617, 123160000620, 123160000838, 123160000841, 123160000894, 123160000897, 123160001110, 123160001139, 123160001140, 123160001148, 123160001927, 123160001931, 123160002176, 123160002179, 123160002185, 123160002188, 123180000697, 123180000705, 123180000896, 123180001052, 123180001115, 123180001746, 123220000021, 123220000029, 123220000295, 123220000337, 123220000692, 123220000694, 123230001000, 123230001004, 123230001005, 123230001006, 123230001069, 123230001077, 123230001078, 123230001759, 123260000197, 123260000202, 123260000220, 123260000234, 123260000236, 123260000239, 123260000240, 123260000371, 123260000480, 123260000697, 123260000698, 123260000701, 123260000704, 123260001756, 123260001763, 123260001985, 123260002018, 123260002023, 123260002024, 123260002029, 123260002380, 123260002382, 123260002384, 123300001421, 123300001684, 123350001047, 123440000097, 123450001663, 124080000664, 124080000674, 124080000676, 124080000717, 124080000734, 124080000771, 124080000782, 124080000858, 124080000864, 124080001408, 124080001595, 124080001597, 124080001611, 124080001613, 124140000635, 124140000667, 124140000669, 124140000670, 124140001188, 124200002487.

Distribution pattern

US, Nationwide Distribution

device · product 3 of 4

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

Z-0886-2025
Recall number
Z-0886-2025
Initiated
December 20, 2024
Classification
Class I
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 00887761981638, Serial Numbers: 122010001081

Distribution pattern

US, Nationwide Distribution

device · product 4 of 4

Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Z-0887-2025
Recall number
Z-0887-2025
Initiated
December 20, 2024
Classification
Class I
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081

Distribution pattern

US, Nationwide Distribution