CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report

BD Recanalization System recalled by Bard Peripheral Vascular

Bard Peripheral Vascular is recalling BD Recanalization System, distributed in 34 states. The recall was initiated on 14 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled403

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-0676-2024
FDA event ID: 93607
Recalling firm: Bard Peripheral Vascular, Tempe, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 14 Nov 2023
FDA classified: 5 Jan 2024
Reported: 17 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

14 Nov 2023	Recall initiated by company
5 Jan 2024	Classified by FDA	+52 days
17 Jan 2024	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

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.

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

BD Recanalization System, REF: BDRECANSYSTEM

Where it was distributed

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

Alabama Arkansas Arizona California Colorado District of Columbia Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Minnesota

Questions about this recall

Is BD Recanalization System recalled?

Yes. Bard Peripheral Vascular recalled BD Recanalization System on 14 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0676-2024.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

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 21 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 Bard Peripheral Vascular

All 138

Reported	Class	Recall	Company	Reason	Where
25 Feb 2026Device	CLASS II	Broviac Single-Lumen CV Catheter Cutdown Tray recalled	Bard Peripheral Vascular	Sterility	Nationwide
17 Dec 2025Device	CLASS II	Safe-T-Centesis Catheter Drainage Tray recalled	Bard Peripheral Vascular	Lead & Heavy Metals	Nationwide
8 Oct 2025Device	CLASS II	Venclose digiRF Generators recalled by Bard Peripheral Vascular	Bard Peripheral Vascular	Temperature Abuse	Nationwide
12 Mar 2025Device	CLASS I	Rotarex Atherectomy System and Instructions for Use recalled	Bard Peripheral Vascular	Lead & Heavy Metals	Nationwide
27 Nov 2024Device	CLASS II	Bard Marquee Disposable Core Biopsy Instrument Kit: Bard Marquee Kit recalled	Bard Peripheral Vascular	Lead & Heavy Metals	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