Recall archive / FDA device enforcement

BD Recanalization System, REF: BDRECANSYSTEM — FDA record Z-0676-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 14, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: BD Recanalization System, REF: BDRECANSYSTEM
Reason: Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
Classification: Class II
Recalling firm: Bard Peripheral Vascular Inc
Quantity: 403
Agency-reported status: Ongoing
Source record identifier: Z-0676-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	UDI-DI: 00801741202421. Serial Numbers: BSX000001, BSX000002, BSX000003, BSX000004, BSX000005, BSX000006, BSX000007, BSX000008, BSX000009, BSX000010, BSX000011, BSX000012, BSX000013, BSX000014, BSX000015, BSX000016, BSX000017, BSX000018, BSX000019, BSX000020, BSX000021, BSX000022, BSX000023, BSX000024, BSX000025, BSX000026, BSX000027, BSX000028, BSX000029, BSX000030, BSX000031, BSX000032, BSX000033, BSX000034, BSX000035, BSX000036, BSX000037, BSX000038, BSX000039, BSX000040, BSX000041, BSX000042, BSX000043, BSX000044, BSX000045, BSX000046, BSX000047, BSX000048, BSX000049, BSX000050, BSX000051, BSX000052, BSX000053, BSX000054, BSX000055, BSX000056, BSX000057, BSX000058, BSX000059, BSX000060, BSX000061, BSX000062, BSX000063, BSX000064, BSX000065, BSX000066, BSX000067, BSX000068, BSX000109, BSX000110, BSX000111, BSX000112, BSX000113, BSX000114, BSX000115, BSX000116, BSX000117, BSX000118, BSX000119, BSX000120, BSX000121, BSX000122, BSX000123, BSX000124, BSX000125, BSX000126, BSX000127, BSX000128, BSX000129, BSX000130, BSX000131, BSX000132, BSX000133, BSX000134, BSX000135, BSX000136, BSX000137, BSX000138, BSX000139, BSX000140, BSX000141, BSX000142, BSX000143, BSX000144, BSX000145, BSX000146, BSX000147, BSX000148, BSX000149, BSX000150, BSX000151, BSX000152, BSX000153, BSX000154, BSX000155, BSX000156, BSX000157, BSX000158, BSX000159, BSX000160, BSX000161, BSX000162, BSX000163, BSX000164, BSX000165, BSX000166, BSX000167, BSX000168, BSX000169, BSX000170, BSX000171, BSX000172, BSX000173, BSX000174, BSX000175, BSX000176, BSX000177, BSX000178, BSX000179, BSX000180, BSX000181, BSX000182, BSX000183, BSX000184, BSX000185, BSX000186, BSX000187, BSX000188, BSX000189, BSX000190, BSX000191, BSX000192, BSX000193, BSX000194, BSX000195, BSX000196, BSX000197, BSX000198, BSX000199, BSX000200, BSX000201, BSX000202, BSX000203, BSX000204, BSX000205, BSX000206, BSX000207, BSX000208, BSX000209, BSX000210, BSX000211, BSX000212, BSX000213, BSX000214, BSX000215, BSX000216, BSX000217, BSX000218, BSX000219, BSX000220, BSX000221, BSX000222, BSX000223, BSX000224, BSX000225, BSX000226, BSX000227, BSX000228, BSX000229, BSX000230, BSX000231, BSX000232, BSX000233, BSX000234, BSX000235, BSX000236, BSX000237, BSX000238, BSX000239, BSX000240, BSX000241, BSX000242, BSX000243, BSX000244, BSX000245, BSX000246, BSX000247, BSX000248, BSX000249, BSX000250, BSX000251, BSX000252, BSX000253, BSX000254, BSX000255, BSX000256, BSX000257, BSX000258, BSX000259, BSX000260, BSX000261, BSX000262, BSX000263, BSX000264, BSX000265, BSX000266, BSX000267, BSX000268, BSX000269, BSX000270, BSX000271, BSX000272, BSX000273, BSX000274, BSX000275, BSX000276, BSX000277, BSX000278, BSX000279, BSX000280, BSX000281, BSX000282, BSX000283, BSX000284, BSX000285, BSX000286, BSX000287, BSX000288, BSX000289, BSX000290, BSX000291, BSX000292, BSX000293, BSX000294, BSX000295, BSX000296, BSX000297, BSX000298, BSX000299, BSX000300, BSX000301, BSX000302, BSX000303, BSX000304, BSX000305, BSX000306, BSX000307, BSX000308, BSX000309, BSX000310, BSX000311, BSX000312, BSX000313, BSX000314, BSX000315, BSX000316, BSX000317, BSX000318, BSX000319, BSX000320, BSX000321, BSX000322, BSX000323, BSX000324, BSX000325, BSX000326, BSX000327, BSX000328, BSX000330, BSX000331, BSX000332, BSX000333, BSX000334, BSX000335, BSX000336, BSX000337, BSX000338, BSX000339, BSX000340, BSX000341, BSX000342, BSX000343, BSX000344, BSX000345, BSX000346, BSX000347, BSX000348, BSX000349, BSX000350, BSX000351, BSX000352, BSX000353, BSX000354, BSX000355, BSX000356, BSX000357, BSX000358, BSX000359, BSX000360, BSX000361, BSX000362, BSX000363, BSX000364, BSX000365, BSX000366, BSX000367, BSX000368, BSX000369, BSX000370, BSX000371, BSX000372, BSX000373, BSX000374, BSX000375, BSX000376, BSX000377, BSX000378, BSX000379, BSX000380, BSX000381, BSX000382, BSX000383, BSX000384, BSX000385, BSX000386, BSX000387, BSX000388, BSX000389, BSX000390, BSX000391, BSX000392, BSX000393, BSX000394, BSX000395, BSX000396, BSX000397, BSX000398, BSX000399, BSX000400, BSX000401, BSX000402, BSX000403, BSX000404, BSX000405, BSX000406, BSX000407, BSX000408, BSX000409, BSX000410, BSX000411, BSX000412, BSX000413, BSX000414, BSX000415, BSX000416, BSX000417, BSX000418, BSX000419, BSX000420, BSX000421, BSX000422, BSX000423, BSX000424, BSX000425, BSX000426, BSX000427, BSX000428, BSX000429, BSX000430, BSX000431, BSX000432, BSX000433, BSX000434, BSX000435, BSX000436, BSX000437, BSX000438, BSX000439, BSX000440, BSX000441, BSX000442, BSX000443, BSX000444

Label field

Details supplied by the agency

Lot, code or applicability

UDI-DI: 00801741202421. Serial Numbers: BSX000001, BSX000002, BSX000003, BSX000004, BSX000005, BSX000006, BSX000007, BSX000008, BSX000009, BSX000010, BSX000011, BSX000012, BSX000013, BSX000014, BSX000015, BSX000016, BSX000017, BSX000018, BSX000019, BSX000020, BSX000021, BSX000022, BSX000023, BSX000024, BSX000025, BSX000026, BSX000027, BSX000028, BSX000029, BSX000030, BSX000031, BSX000032, BSX000033, BSX000034, BSX000035, BSX000036, BSX000037, BSX000038, BSX000039, BSX000040, BSX000041, BSX000042, BSX000043, BSX000044, BSX000045, BSX000046, BSX000047, BSX000048, BSX000049, BSX000050, BSX000051, BSX000052, BSX000053, BSX000054, BSX000055, BSX000056, BSX000057, BSX000058, BSX000059, BSX000060, BSX000061, BSX000062, BSX000063, BSX000064, BSX000065, BSX000066, BSX000067, BSX000068, BSX000109, BSX000110, BSX000111, BSX000112, BSX000113, BSX000114, BSX000115, BSX000116, BSX000117, BSX000118, BSX000119, BSX000120, BSX000121, BSX000122, BSX000123, BSX000124, BSX000125, BSX000126, BSX000127, BSX000128, BSX000129, BSX000130, BSX000131, BSX000132, BSX000133, BSX000134, BSX000135, BSX000136, BSX000137, BSX000138, BSX000139, BSX000140, BSX000141, BSX000142, BSX000143, BSX000144, BSX000145, BSX000146, BSX000147, BSX000148, BSX000149, BSX000150, BSX000151, BSX000152, BSX000153, BSX000154, BSX000155, BSX000156, BSX000157, BSX000158, BSX000159, BSX000160, BSX000161, BSX000162, BSX000163, BSX000164, BSX000165, BSX000166, BSX000167, BSX000168, BSX000169, BSX000170, BSX000171, BSX000172, BSX000173, BSX000174, BSX000175, BSX000176, BSX000177, BSX000178, BSX000179, BSX000180, BSX000181, BSX000182, BSX000183, BSX000184, BSX000185, BSX000186, BSX000187, BSX000188, BSX000189, BSX000190, BSX000191, BSX000192, BSX000193, BSX000194, BSX000195, BSX000196, BSX000197, BSX000198, BSX000199, BSX000200, BSX000201, BSX000202, BSX000203, BSX000204, BSX000205, BSX000206, BSX000207, BSX000208, BSX000209, BSX000210, BSX000211, BSX000212, BSX000213, BSX000214, BSX000215, BSX000216, BSX000217, BSX000218, BSX000219, BSX000220, BSX000221, BSX000222, BSX000223, BSX000224, BSX000225, BSX000226, BSX000227, BSX000228, BSX000229, BSX000230, BSX000231, BSX000232, BSX000233, BSX000234, BSX000235, BSX000236, BSX000237, BSX000238, BSX000239, BSX000240, BSX000241, BSX000242, BSX000243, BSX000244, BSX000245, BSX000246, BSX000247, BSX000248, BSX000249, BSX000250, BSX000251, BSX000252, BSX000253, BSX000254, BSX000255, BSX000256, BSX000257, BSX000258, BSX000259, BSX000260, BSX000261, BSX000262, BSX000263, BSX000264, BSX000265, BSX000266, BSX000267, BSX000268, BSX000269, BSX000270, BSX000271, BSX000272, BSX000273, BSX000274, BSX000275, BSX000276, BSX000277, BSX000278, BSX000279, BSX000280, BSX000281, BSX000282, BSX000283, BSX000284, BSX000285, BSX000286, BSX000287, BSX000288, BSX000289, BSX000290, BSX000291, BSX000292, BSX000293, BSX000294, BSX000295, BSX000296, BSX000297, BSX000298, BSX000299, BSX000300, BSX000301, BSX000302, BSX000303, BSX000304, BSX000305, BSX000306, BSX000307, BSX000308, BSX000309, BSX000310, BSX000311, BSX000312, BSX000313, BSX000314, BSX000315, BSX000316, BSX000317, BSX000318, BSX000319, BSX000320, BSX000321, BSX000322, BSX000323, BSX000324, BSX000325, BSX000326, BSX000327, BSX000328, BSX000330, BSX000331, BSX000332, BSX000333, BSX000334, BSX000335, BSX000336, BSX000337, BSX000338, BSX000339, BSX000340, BSX000341, BSX000342, BSX000343, BSX000344, BSX000345, BSX000346, BSX000347, BSX000348, BSX000349, BSX000350, BSX000351, BSX000352, BSX000353, BSX000354, BSX000355, BSX000356, BSX000357, BSX000358, BSX000359, BSX000360, BSX000361, BSX000362, BSX000363, BSX000364, BSX000365, BSX000366, BSX000367, BSX000368, BSX000369, BSX000370, BSX000371, BSX000372, BSX000373, BSX000374, BSX000375, BSX000376, BSX000377, BSX000378, BSX000379, BSX000380, BSX000381, BSX000382, BSX000383, BSX000384, BSX000385, BSX000386, BSX000387, BSX000388, BSX000389, BSX000390, BSX000391, BSX000392, BSX000393, BSX000394, BSX000395, BSX000396, BSX000397, BSX000398, BSX000399, BSX000400, BSX000401, BSX000402, BSX000403, BSX000404, BSX000405, BSX000406, BSX000407, BSX000408, BSX000409, BSX000410, BSX000411, BSX000412, BSX000413, BSX000414, BSX000415, BSX000416, BSX000417, BSX000418, BSX000419, BSX000420, BSX000421, BSX000422, BSX000423, BSX000424, BSX000425, BSX000426, BSX000427, BSX000428, BSX000429, BSX000430, BSX000431, BSX000432, BSX000433, BSX000434, BSX000435, BSX000436, BSX000437, BSX000438, BSX000439, BSX000440, BSX000441, BSX000442, BSX000443, BSX000444

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA, NM, CO, KY, ME, MN

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jan 17, 2024
Recall initiation date: Nov 14, 2023
Center classification date: Jan 5, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records