CLASS II ONGOING Device recall · Reported 19 Jul 2023 · FDA Enforcement Report

Allen Advance Chest Support with Pad recalled by Baxter Healthcare

Baxter Healthcare is recalling Allen Advance Chest Support with Pad, distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct code A-71301; GTIN Number: (01)00615521003159; a. Lot Codes: 19-238, 19-238, 19-287, 19-337, 19-337, 19-352, 20-225, 21-085, 21-102, 21-102, 20-326, 19-170, 19-170, 19-150, 19-150, 19-162, 19-326, 20-031, 20-072, 20-245, 19-235, 20-091, 21-057, 19-352, 20-031, 20-044, 20-063, 20-245, 20-245, 20-259, 20-259, 21-109, 21-109, 20-064, 20-225, 21-014, 19-190, 19-326, 20-014, 20-014, 20-063, 20-259, 20-259, 21-085, 21-048, 19-287, 20-072, 19-295, 19-302, 21-085, 19-134, 19-179, 19-179, 19-235, 19-235, 20-014, 20-326, 20-343, 21-085, 19-150, 21-014, 20-357, 20-009, 20-042, 20-064, 21-109, 19-287, 19-287, 19-287, 19-288, 20-031, 20-043, 20-043, 20-063, 20-091, 20-225, 20-309, 20-318, 21-036, 21-036, 21-036, 21-036, 19-141, 19-150, 19-150, 19-150, 19-150, 19-162, 19-162, 19-150, 19-150, 19-157, 19-157, 19-161, 19-161, 19-179, 19-190, 19-190, 19-190, 19-190, 19-161, 19-190, 19-179, 19-179, 19-238, 19-238, 19-238, 19-238, 19-238, 19-235, 19-179, 19-179, 19-235, 19-235, 19-235, 19-179, 19-295, 19-295, 19-287, 19-287, 19-287, 19-344, 19-302, 19-344, 19-344, 19-302, 19-287, 19-179, 20-009, 19-288, 19-288, 19-288, 19-288, 19-288, 19-288, 19-288, 20-043, 20-035, 19-352, 20-044, 20-042, 20-064, 20-031, 20-063, 20-044, 20-014, 20-031, 20-042, 20-042, 20-042, 20-042, 20-225, 20-223, 20-245, 20-245, 20-245, 20-240, 20-259, 20-259, 20-318, 20-318, 20-259, 20-318, 20-326, 20-326, 20-309, 20-343, 20-357, 21-005, 21-005, 20-357, 21-005, 21-005, 21-014, 21-014, 20-357, 21-048, 21-048, 21-048, 21-057, 21-057, 21-057, 21-079, 21-079, 21-079, 21-109, 21-109, 21-109, 21-109, 21-109, 20-073, 21-102, 21-102, 19-219, 20-245, 20-290, 19-141, 19-141, 19-150, 19-150, 19-190, 19-235, 20-031, 20-042, 20-091, 20-245, 20-245, 19-141, 19-150, 19-157, 19-190, 19-190, 19-235, 19-235, 19-238, 19-238, 19-238, 19-287, 19-288, 19-295, 19-326, 20-009, 20-042, 20-063, 20-063, 20-072, 20-223, 20-223, 20-240, 20-240, 20-042, 20-309, 21-048; b. Serial Numbers: A310704, A357947, A360200, A365287, A375034, A375035, A375036, A416606, A420046, A448084, A452816, A471811, A277527, A277528, A279563, A279562, A277446, A277526, A282019, A282021, A282023, 429589, A282815, A283349, A282814, A282816, A283901, A283902, A283905, A283348, A284963, A285887, A285889, A285891, A284961, A284303, A284304, A284298, A286694, A285890, A291760, A287624, A285888, A287623, A292761, A292758, A292754, A292764, A287622, A294806, A294807, A292757, A292756, A294805, A297712, A296452, A297713, A294803, A300078, A300079, A294810, A302576, A304247, A304248, A304246, A305685, A305686, A294804, A305290, A305289, A305688, A306433, A306706, A306705, A306704, A306434, A308755, A308756, A305287, A305288, A310148, A310702, A310149, A310703, A306436, A308184, A313214, 395159, A314036, A313215, A315373, A310150, A315374, A315375, A306435, A309415, A308757, A314482, A314483, A315892, A315893, A317667, A317666, A309416, A316612, A316613, A315891, A314481, A315894, A315895, A316614, A317668, A318948, A318949, A318064, A318950, A318065, A318066, A319766, A319767, A321937, A319765, A321938, A321936, A320448, A322426, A322427, A320852, A324672, A324670, A325034, A324673, A325038, A325035, A325037, A327579, A326495, A327581, A326497, A328335, A324674, A328699, A328332, A328334, A328333, A328336, A326496, A328697, A330272, A330273, A330275, A326499, A329153, A329154, A329152, A326498, A330274, A328700, A328696, A329155, A333390, A333393, A334200, A334199, A334197, A337070, A334201, A337541, A335292, A337071, A337072, A338188, A338190, A335293, A337073, A339467, A338187, A338186, A339468, A339469, A339471, A340661, A340663, A340662, A340659, A337542, A342758, A342299, A342761, A342762, A342300, A343762, A342760, A343760, A343180, A343182, A342301, A342759, A335294, A335295, A346956, A343179, A348719, A347562, A343181, A349179, A349178, A349176, A349925, A349923, A349924, A349926, A337074, A349180, A349927, A348717, A346958, A348718, A349177, A346954, A353968, A353967, A346957, A356578, A356575, A355198, A356577, A357943, A358744, A357946, A358747, A360196, A360198, A356576, A355196, A355197, A356574, A361153, A363379, A363380, A365290, A365288, A361155, A364647, A364650, A364648, A361154, A361157, A366894, A366897, A361156, A366895, A369285, A371200, A371833, A371831, A370964, A370968, A373009, A373007, A373010, A373011, A371201, A371204, A370966, A375500, A375501, A373974, A373975, A373976, A378135, A378136, A370967, A375037, A376988, A380128, A380127, A376986, A376987, A380126, A380129, A381012, A381013, A381009, A375502, A384933, A347558, A347559, A386376, A376984, A376985, A384937, A388848, A387925, A387923, A385776, A385779, A385780, A387924, A391327, A391328, A388847, A391324, A385777, A387406, A387410, A387408, A387407, A396340, A396341, A395917, A395918, A395919, A395920, A397230, A391326, A397234, A397232, A347561, A393696, A393693, A387409, A393694, A393695, A392498, A397233, A320447, A401570, A392500, A401574, A393697, A402910, A402911, A404480, A388846, A405307, A406883, A406887, A405305, A408249, A406885, A408246, A408247, A408248, A406884, A409140, A404484, A409142, A410098, A410096, A410099, A410095, A412218, A412222, A389898, A412220, A412219, A411532, A413045, A413049, A413047, A413048, A413747, A413748, A411531, A416604, A416607, A415777, A415776, A286693, A415775, A417502, A417504, A418527, A420049, A420047, A417501, A420045, A420048, A417503, A418529, A392497, A422259, A422260, A422254, A422255, A422261, A422258, A423366, A423365, A423362, A423363, A422256, A422262, A425350, A425349, A425849, A425848, A425355, A425850, A428078, A426843, A428079, A422253, A426847, A425354, A428081, A428082, A430036, A430626, A430035, A423364, A425348, A425847, A430889, A432302, A431880, A432304, A430888, A434264, A434263, A434546, A434548, A434549, A435902, A435900, A435903, A366893, A436095, A436092, A436091, A435899, A435901, A434550, A441729, A441732, A441730, A442316, A442317, A442318, A444339, A444338, A444336, A444598, A444599, A444600, A445304, A445303, A444601, A445305, A446058, A446059, A447482, A447483, A447479, A447480, A448082, A448083, A449263, A447481, A449264, A449265, A449262, A445302, A451721, A451722, A451723, A452815, A453772, A453771, A454423, A456229, A456228, A456864, A457580, A456863, A378138, A456375, A456376, A458653, A458655, A459953, A460528, A459954, A460996, A460998, A460530, A460531, A461945, A463227, A463228, A464880, A464881, A464882, A464883, A465576, A465575, A465577, A466360, A459955, A468113, A470003, A470002, A468114, A470561, A470562, A471812, A471813, A472122, A472123, A472124, A472125, A472545, A472544, A472543, A473809, A473808, A473810, A476032, A476033, A475324, A463856, A473811, A478212, A478210, A478211, A478209, A395921, A480983, A480984, A480985, A481073, A481076, A481074, A481075, A481402, A323844, A323845, A365289, A380125, A456374, A475322, A282020, A292755, A286696, A337540, A342302, A343761, A353969, A353970, A358745, A378137, A401572, A412221, A416603, A425352, A425846, A449656, A458172, A284301, A415774, A456230, A411534, A430890, A282813, A346955, A384934, A384935, A384936, A389896, A402908, A402912, A404483, A417505, A418526, A422257, A430627, A458171, A460999, A468106, A468107, A468108, A468109, A468110, A313213, A327578, A330276, A475323, A342303, A369287, A432303, A276164, A276165, A279560, A279565, A283900, A283903, A283904, A284296, A286695, A296451, A302574, A302575, A308185, A309417, A320853, A320854, A333391, A333392, A340660, A355200, A357944, A357945, A358746, A360199, A363381, A364649, A366896, A369283, A369284, A369286, A371829, A371830, A370965, A373008, A375503, A373977, A381010, A381011, A386378, A386379, A388845, A389895, A389897, A392499, A392501, A401573, A404482, A406886, A410097, A411533, A413744, A413745, A413746, A415778, A426845, A426846, A428080, A430034, A431879, A434262, A436093, A441731, A442801, A442802, A444337, A446056, A446057, A449654, A451724, A452813, A452814, A461648, A461649, A461650, A461946, A461947, A461948, A468112, A470001, A473031, A473032, A476030, A476031, A480986, A480987, A396338, A472546, A360197, A300077, A328698, A348721, A426844, A347560, A386377, A468111, A364651, A459956, A305687, A348720, A425353, A425356, A408245, A334198, A375504, A387922, A431881, A409143, A338189, A308186, A294802, A297016, A396339, A396342, A292762, A339470, A416605, A418525, A297711, A320446, A355199, A389894, A442799, A442800, A442315, A276166, A284302, A365286, A449657, A473033, A473034, A281813, A284299, A314035, A323126, A323127, A323128, A322428, A323846, A323847, A323848, A323849, A324669, A324671, A325033, A325036, A327117, A327118, A327119, A327120, A327121, A326500, A337543, A358748, A387921, A454422, A457581, A458652, A463857, A281814, A314037, A329151, A335291, A337539, A343758, A343759, A371832, A371202, A375033, A402909, A404481, A409141, A425347, A425351, A430628, A436094, A458654, A460529, A460997, A461651, A475321, A294809, A305684, A471814, A481403, A481404, A481405

Quantity recalled1,010 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2109-2023
FDA event ID: 92375
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 18 May 2023
FDA classified: 7 Jul 2023
Reported: 19 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

18 May 2023	Recall initiated by company
7 Jul 2023	Classified by FDA	+50 days
19 Jul 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Allen Advance Chest Support with Pad

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Belgium, Croatia, Denmark, Egypt, France, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

Which lots are affected?

Product code A-71301; GTIN Number: (01)00615521003159; a. Lot Codes: 19-238, 19-238, 19-287, 19-337, 19-337, 19-352, 20-225, 21-085, 21-102, 21-102, 20-326, 19-170, 19-170, 19-150, 19-150, 19-162, 19-326, 20-031, 20-072, 20-245, 19-235, 20-091, 21-057, 19-352, 20-031, 20-044, 20-063, 20-245, 20-245, 20-259, 20-259, 21-109, 21-109, 20-064, 20-225, 21-014, 19-190, 19-326, 20-014, 20-014, 20-063, 20-259, 20-259, 21-085, 21-048, 19-287, 20-072, 19-295, 19-302, 21-085, 19-134, 19-179, 19-179, 19-235, 19-235, 20-014, 20-326, 20-343, 21-085, 19-150, 21-014, 20-357, 20-009, 20-042, 20-064, 21-109, 19-287, 19-287, 19-287, 19-288, 20-031, 20-043, 20-043, 20-063, 20-091, 20-225, 20-309, 20-318, 21-036, 21-036, 21-036, 21-036, 19-141, 19-150, 19-150, 19-150, 19-150, 19-162, 19-162, 19-150, 19-150, 19-157, 19-157, 19-161, 19-161, 19-179, 19-190, 19-190, 19-190, 19-190, 19-161, 19-190, 19-179, 19-179, 19-238, 19-238, 19-238, 19-238, 19-238, 19-235, 19-179, 19-179, 19-235, 19-235, 19-235, 19-179, 19-295, 19-295, 19-287, 19-287, 19-287, 19-344, 19-302, 19-344, 19-344, 19-302, 19-287, 19-179, 20-009, 19-288, 19-288, 19-288, 19-288, 19-288, 19-288, 19-288, 20-043, 20-035, 19-352, 20-044, 20-042, 20-064, 20-031, 20-063, 20-044, 20-014, 20-031, 20-042, 20-042, 20-042, 20-042, 20-225, 20-223, 20-245, 20-245, 20-245, 20-240, 20-259, 20-259, 20-318, 20-318, 20-259, 20-318, 20-326, 20-326, 20-309, 20-343, 20-357, 21-005, 21-005, 20-357, 21-005, 21-005, 21-014, 21-014, 20-357, 21-048, 21-048, 21-048, 21-057, 21-057, 21-057, 21-079, 21-079, 21-079, 21-109, 21-109, 21-109, 21-109, 21-109, 20-073, 21-102, 21-102, 19-219, 20-245, 20-290, 19-141, 19-141, 19-150, 19-150, 19-190, 19-235, 20-031, 20-042, 20-091, 20-245, 20-245, 19-141, 19-150, 19-157, 19-190, 19-190, 19-235, 19-235, 19-238, 19-238, 19-238, 19-287, 19-288, 19-295, 19-326, 20-009, 20-042, 20-063, 20-063, 20-072, 20-223, 20-223, 20-240, 20-240, 20-042, 20-309, 21-048; b. Serial Numbers: A310704, A357947, A360200, A365287, A375034, A375035, A375036, A416606, A420046, A448084, A452816, A471811, A277527, A277528, A279563, A279562, A277446, A277526, A282019, A282021, A282023, 429589, A282815, A283349, A282814, A282816, A283901, A283902, A283905, A283348, A284963, A285887, A285889, A285891, A284961, A284303, A284304, A284298, A286694, A285890, A291760, A287624, A285888, A287623, A292761, A292758, A292754, A292764, A287622, A294806, A294807, A292757, A292756, A294805, A297712, A296452, A297713, A294803, A300078, A300079, A294810, A302576, A304247, A304248, A304246, A305685, A305686, A294804, A305290, A305289, A305688, A306433, A306706, A306705, A306704, A306434, A308755, A308756, A305287, A305288, A310148, A310702, A310149, A310703, A306436, A308184, A313214, 395159, A314036, A313215, A315373, A310150, A315374, A315375, A306435, A309415, A308757, A314482, A314483, A315892, A315893, A317667, A317666, A309416, A316612, A316613, A315891, A314481, A315894, A315895, A316614, A317668, A318948, A318949, A318064, A318950, A318065, A318066, A319766, A319767, A321937, A319765, A321938, A321936, A320448, A322426, A322427, A320852, A324672, A324670, A325034, A324673, A325038, A325035, A325037, A327579, A326495, A327581, A326497, A328335, A324674, A328699, A328332, A328334, A328333, A328336, A326496, A328697, A330272, A330273, A330275, A326499, A329153, A329154, A329152, A326498, A330274, A328700, A328696, A329155, A333390, A333393, A334200, A334199, A334197, A337070, A334201, A337541, A335292, A337071, A337072, A338188, A338190, A335293, A337073, A339467, A338187, A338186, A339468, A339469, A339471, A340661, A340663, A340662, A340659, A337542, A342758, A342299, A342761, A342762, A342300, A343762, A342760, A343760, A343180, A343182, A342301, A342759, A335294, A335295, A346956, A343179, A348719, A347562, A343181, A349179, A349178, A349176, A349925, A349923, A349924, A349926, A337074, A349180, A349927, A348717, A346958, A348718, A349177, A346954, A353968, A353967, A346957, A356578, A356575, A355198, A356577, A357943, A358744, A357946, A358747, A360196, A360198, A356576, A355196, A355197, A356574, A361153, A363379, A363380, A365290, A365288, A361155, A364647, A364650, A364648, A361154, A361157, A366894, A366897, A361156, A366895, A369285, A371200, A371833, A371831, A370964, A370968, A373009, A373007, A373010, A373011, A371201, A371204, A370966, A375500, A375501, A373974, A373975, A373976, A378135, A378136, A370967, A375037, A376988, A380128, A380127, A376986, A376987, A380126, A380129, A381012, A381013, A381009, A375502, A384933, A347558, A347559, A386376, A376984, A376985, A384937, A388848, A387925, A387923, A385776, A385779, A385780, A387924, A391327, A391328, A388847, A391324, A385777, A387406, A387410, A387408, A387407, A396340, A396341, A395917, A395918, A395919, A395920, A397230, A391326, A397234, A397232, A347561, A393696, A393693, A387409, A393694, A393695, A392498, A397233, A320447, A401570, A392500, A401574, A393697, A402910, A402911, A404480, A388846, A405307, A406883, A406887, A405305, A408249, A406885, A408246, A408247, A408248, A406884, A409140, A404484, A409142, A410098, A410096, A410099, A410095, A412218, A412222, A389898, A412220, A412219, A411532, A413045, A413049, A413047, A413048, A413747, A413748, A411531, A416604, A416607, A415777, A415776, A286693, A415775, A417502, A417504, A418527, A420049, A420047, A417501, A420045, A420048, A417503, A418529, A392497, A422259, A422260, A422254, A422255, A422261, A422258, A423366, A423365, A423362, A423363, A422256, A422262, A425350, A425349, A425849, A425848, A425355, A425850, A428078, A426843, A428079, A422253, A426847, A425354, A428081, A428082, A430036, A430626, A430035, A423364, A425348, A425847, A430889, A432302, A431880, A432304, A430888, A434264, A434263, A434546, A434548, A434549, A435902, A435900, A435903, A366893, A436095, A436092, A436091, A435899, A435901, A434550, A441729, A441732, A441730, A442316, A442317, A442318, A444339, A444338, 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A481404, A481405

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Baxter Healthcare

All 573

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Drug	CLASS II	Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide