Recalls affecting New York

FDA has not published a risk classification for this recall yet.

Recall #:

99352

Lot/product code:

FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325

Recalling firm:

PHILIPS MEDICAL SYSTEMS

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0648-2026

Lot/product code:

Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028.

Recalling firm:

CareFusion 213, LLC

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0644-2026

Lot/product code:

Lot: 4298581, expires: 09/30/2026.

Recalling firm:

CareFusion 213, LLC

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0646-2026

Lot/product code:

Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.

Recalling firm:

CareFusion 213, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

98893

Lot/product code:

Pump Set Code 0048-0014; Introducer Product Code 0052-3046. GTIN: 00813502012873, 00813502013344, 00813502013368, 04260113630280. All current batches in field.

Recalling firm:

Abiomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

99352

Lot/product code:

FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232

Recalling firm:

PHILIPS MEDICAL SYSTEMS

FDA has not published a risk classification for this recall yet.

Recall #:

98893

Lot/product code:

Pump Set Codes 1000459, 1000460; Introducer Product Code 0052-3006-JP. GTIN: 00813502013054. All current batches in field.

Recalling firm:

Abiomed, Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0663-2026

Lot/product code:

Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707 & 0001920638 June 2026 Lot 0001927080 Oct 2026 Lots 0001937896, 0001952194 & 0001962232, Jan-2027 Lots 0001981964, 0001981965, 0001994680 & 002012768, May 2027 Lot 0001998027, Jun 2027 Lot 002012787, Aug 2027

Recalling firm:

BioMed Laboratories, LLC.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0643-2026

Lot/product code:

Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.

Recalling firm:

CareFusion 213, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

98893

Lot/product code:

Pump Set Code 0048-0024-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011609. All current batches in field.

Recalling firm:

Abiomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98893

Lot/product code:

Pump Set Code 1000323; introducer Product Code 2000342. GTIN 00813502012811. All current batches in field.

Recalling firm:

Abiomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98893

Lot/product code:

Pump Set Code 0052-0011-JP; Introducer Product Code 0052-3006-JP. GTIN: 00813502011340. All current batches in field.

Recalling firm:

Abiomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98893

Lot/product code:

Pump Set Code 0052-0039; Introducer Product Code 0052-3053. GTIN: 00813502011715, 00813502012736. All current batches in field.

Recalling firm:

Abiomed, Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0650-2026

Lot/product code:

Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.

Recalling firm:

CareFusion 213, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

98893

Lot/product code:

Pump Set Code 0048-0044; Introducer Product Code 0052-3046. GTIN: 00813502012200. All current batches in field.

Recalling firm:

Abiomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98893

Lot/product code:

Pump Set Codes 1000211, 1000212; Introducer Product Code 0052-3006-JP. GTIN: 00813502012453. All current batches in field.

Recalling firm:

Abiomed, Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0652-2026

Lot/product code:

Lot: 4190081, Exp 06/30/2027

Recalling firm:

CareFusion 213, LLC

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0651-2026

Lot/product code:

Lot: 4088933, Exp 03/31/2027, 4177711, 4195438, Exp 06/30/2027, 5051114, Exp 02/29/2028, 5070540, Exp 03/31/2028, 5106254, Exp 04/30/2028, 5141607, Exp 05/31/2028, 5196494, Exp 07/31/2028.

Recalling firm:

CareFusion 213, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

99352

Lot/product code:

FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542

Recalling firm:

PHILIPS MEDICAL SYSTEMS

FDA has not published a risk classification for this recall yet.

Recall #:

99263

Lot/product code:

Lot Code: MC2; UDI 00860008892782; Serial Numbers 1523, 1527, 1488, 1528, 1529, 1544 MC2.1; UDI 00850079606043; Serial Numbers: 1461, 1462, 1547 Full UDI for affected devices: (01)00860008892782(11)260107(21)1523 (01)00860008892782(11)260129(21)1527 (01)00860008892782(11)260109(21)1488 (01)00860008892782(11)260123(21)1528 (01)00860008892782(11)260130(21)1529 (01)00860008892782(11)260227(21)1544 (01)00850079606043(11)260407(21)1461 (01)00850079606043(11)260407(21)1462 (01)00850079606043(11)260408(21)1547

Recalling firm:

Oxos Medical Inc

FDA has not published a risk classification for this recall yet.

Recall #:

99329

Lot/product code:

Medline Kit SKU DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25BBD107; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBD534; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBL772.

Recalling firm:

Medline Industries, LP

FDA has not published a risk classification for this recall yet.

Recall #:

98893

Lot/product code:

Pump Set Code 1000550; Introducer Product Code 0052-3046. GTIN: 00813502013474. All current batches in field.

Recalling firm:

Abiomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

99225

Lot/product code:

All Lots; GTIN# 18032568866681

Recalling firm:

Orthofix U.S. LLC

FDA has not published a risk classification for this recall yet.

Recall #:

99225

Lot/product code:

All Lots; GTIN# 18032568866711

Recalling firm:

Orthofix U.S. LLC

FDA has not published a risk classification for this recall yet.

Recall #:

99192

Lot/product code:

UDI/DI +M335400011, Serial Numbers: 60000316, 60000363, 60000375, 60000388, 60000428, 60000451, 60000469, 60000495, 60000529, 60000569, 60000580, 60000637, 60000643, 60000647, 60000652, 60000668, 60000670, 60000689, 60000692, 60000695, 60000703, 60000706, 60000710, 60000712, 60000716, 60000718, 60000724, 60000726, 60000754, 60000757, 60000759, 60000765, 60000775, 60000776, 60000781, 60000790, 60000793, 60000801, 60000805, 60000816, 60000830, 60000835, 60000850, 60000857, 60000860, 60000879, 60000883, 60000886, 60000899, 60000903, 60000909, 60000916, 60000917, 60000920, 60000927, 60000933, 60000938, 60000939, 60000942, 60000944, 60000948, 60000951, 60000954, 60000959, 60000960, 60000964, 60000966, 60000967, 60000980, 60000985, 60000987, 60000988, 60000990, 60001007, 60001008, 60001013, 60001028, 60001030, 60001031, 60001034, 60001035, 60001036, 60001037, 60001038, 60001039, 60001040, 60001041, 60001042, 60001043, 60001044, 60001045, 60001047, 60001048, 60001049, 60001050, 60001051, 60001052, 60001053, 60001054, 60001055, 60001056, 60001057, 60001058, 60001060, 60001061, 60001062, 60001063, 60001064, 60001065, 60001066, 60001067, 60001068, 60001069, 60001070, 60001071, 60001072, 60001073, 60001074, 60001075, 60001076, 60001077, 60001078, 60001079, 60001080, 60001081, 60001082, 60001083, 60001084, 60001085, 60001086, 60001087, 60001088, 60001089, 60001090, 60001091, 60001092, 60001093, 60001094, 60001095, 60001096, 60001097, 60001098, 60001099, 60001100, 60001101, 60001102, 60001103, 60001104, 60001105, 60001106, 60001107, 60001108, 60001109, 60001110, 60001111, 60001112, 60001113, 60001114, 60001115, 60001116, 60001117, 60001118, 60001119, 60001120, 60001121, 60001122, 60001123, 60001124, 60001125, 60001126, 60001127, 60001128, 60001129, 60001130, 60001131, 60001132, 60001133, 60001134, 60001135, 60001136, 60001138, 60001139, 60001140, 60001142, 60001143, 60001144, 60001145, 60001146, 60001147, 60001148, 60001149, 60001150, 60001151, 60001152, 60001153, 60001154, 60001155, 60001157, 60001158, 60001159, 60001160, 60001161, 60001162, 60001163, 60001164, 60001165, 60001166, 60001167, 60001168, 60001169, 60001170, 60001171, 60001172, 60001173, 60001174, 60001175, 60001176, 60001177, 60001178, 60001179, 60001180, 60001181, 60001182, 60001183, 60001184, 60001185, 60001186, 60001187, 60001188, 60001189, 60001190, 60001191, 60001192, 60001193, 60001194, 60001195, 60001196, 60001197, 60001198, 60001199, 60001200, 60001201, 60001202, 60001203, 60001204, 60001205, 60001206, 60001207, 60001208, 60001209, 60001210, 60001211, 60001212, 60001213, 60001214, 60001215, 60001216, 60001217, 60001218, 60001219, 60001220, 60001221, 60001222, 60001223, 60001224, 60001225, 60001226, 60001227, 60001228, 60001229, 60001230, 60001231, 60001232, 60001233, 60001236, 60001237, 60001238, 60001240, 60001243, 60001245, 60001252, 60001253, 60001255, 60001262, 60001266, 60001271, 60001280, 60001285, 60001286, 60001291, 60001293, 60001295, 60001296, 60001297, 60001300, 60001302, 60001303, 60001304, 60001305, 60001306, 60001307, 60001308, 60001309, 60001310, 60001311, 60001312, 60001313, 60001314, 60001315, 60001316, 60001317, 60001318, 60001319, 60001320, 60001321, 60001322, 60001323, 60001324, 60001325, 60001326, 60001327, 60001328, 60001329, 60001330, 60001331, 60001332, 60001333, 60001334, 60001335, 60001336, 60001337, 60001338, 60001339, 60001340, 60001341, 60001342, 60001343, 60001344, 60001345, 60001346, 60001347, 60001348, 60001349, 60001350, 60001351, 60001352, 60001353, 60001354, 60001355, 60001357, 60001358, 60001359, 60001360, 60001361, 60001362, 60001363, 60001364, 60001365, 60001366, 60001367, 60001368, 60001370, 60001371, 60001373, 60001374, 60001375, 60001376, 60001377, 60001378, 60001380, 60001381, 60001382, 60001383, 60001385, 60001386, 60001387, 60001388, 60001390, 60001391, 60001392, 60001393, 60001394, 60001395, 60001396, 60001397, 60001398, 60001400, 60001401, 60001402, 60001403, 60001404, 60001405, 60001406, 60001407, 60001408, 60001409, 60001410, 60001411, 60001413, 60001414, 60001416, 60001417, 60001418, 60001420, 60001421, 60001422, 60001423, 60001424, 60001425, 60001426, 60001427, 60001428, 60001429, 60001430, 60001431, 60001432, 60001433, 60001434, 60001435, 60001436, 60001438, 60001439, 60001443, 60001444, 60001445, 60001446, 60001447, 60001448, 60001449, 60001451, 60001452, 60001453, 60001454, 60001455, 60001456, 60001457, 60001458, 60001459, 60001461, 60001462, 60001463, 60001464, 60001465, 60001466, 60001467, 60001468, 60001469, 60001470, 60001472, 60001473, 60001475, 60001476, 60001477, 60001478, 60001480, 60001481, 60001482, 60001483, 60001484, 60001485, 60001486, 60001487, 60001488, 60001489, 60001490, 60001492, 60001494, 60001495, 60001496, 60001497, 60001498, 60001499, 60001500, 60001501, 60001502, 60001503, 60001504, 60001506, 60001507, 60001508, 60001509, 60001510, 60001511, 60001512, 60001513, 60001514, 60001516, 60001518, 60001519, 60001520, 60001521, 60001522, 60001523, 60001525, 60001526, 60001527, 600… (truncated, 50626 characters total — see the official FDA record for the full value)

Recalling firm:

ICU Medical, Inc.