FDA Device recall Z-2174-2026

BARD Dynamic Deca Steerable, Product Number 201101

FDA Device
Class II
ongoing
Published 2026-05-20

On 2026-05-20 the FDA classified a Class II recall of BARD Dynamic Deca Steerable, Product Number 201101 by Stryker Sustainability Solutions, citing incomplete seals on sterile product.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2174-2026
Classification	Class II
Status	ongoing
Initiated	2026-04-10
Published	2026-05-20
Last updated	2026-09-13 11:58 UTC
Company	Stryker Sustainability Solutions
Distribution	US

Product

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Reason

Incomplete seals on sterile product

Identifiers

code_info	UDI 00885825003845, Lot Numbers: 3021656, 4158368, 4305347, 4457640, 4560383, 4660045, 4815497, 4881594, 4987017, 5032… UDI 00885825003845, Lot Numbers: 3021656, 4158368, 4305347, 4457640, 4560383, 4660045, 4815497, 4881594, 4987017, 5032942, 3107869, 4160047, 4305348, 4457904, 4562726, 4660052, 4815499, 4881600, 4987018, 5033611, 3171909, 4160048, 4305500, 4460044, 4565142, 4662242, 4816776, 4881613, 4987355, 5033612, 3197667, 4160049, 4305998, 4461505, 4565897, 4662243, 4816890, 4881615, 4989058, 5033626, 3231845, 4160051, 4307998, 4461555, 4565899, 4662546, 4816891, 4881618, 4989060, 5033627, 3241416, 4160053, 4308004, 4461558, 4565901, 4662547, 4816898, 4882585, 4990629, 5033628, 3248595, 4161235, 4309667, 4461560, 4565902, 4662549, 4817898, 4883073, 4990630, 5033673, 3254499, 4161239, 4311144, 4461580, 4565903, 4662550, 4818896, 4883093, 4990647, 5033679, 3259151, 4162340, 4311159, 4461628, 4565904, 4662551, 4818897, 4883094, 4990648, 5034212, 3272697, 4163622, 4311161, 4461639, 4565905, 4662552, 4818901, 4883096, 4990649, 5034213, 3304525, 4163719, 4312042, 4461640, 4565906, 4662560, 4820191, 488

code_info

UDI 00885825003845, Lot Numbers: 3021656, 4158368, 4305347, 4457640, 4560383, 4660045, 4815497, 4881594, 4987017, 5032…

UDI 00885825003845, Lot Numbers: 3021656, 4158368, 4305347, 4457640, 4560383, 4660045, 4815497, 4881594, 4987017, 5032942, 3107869, 4160047, 4305348, 4457904, 4562726, 4660052, 4815499, 4881600, 4987018, 5033611, 3171909, 4160048, 4305500, 4460044, 4565142, 4662242, 4816776, 4881613, 4987355, 5033612, 3197667, 4160049, 4305998, 4461505, 4565897, 4662243, 4816890, 4881615, 4989058, 5033626, 3231845, 4160051, 4307998, 4461555, 4565899, 4662546, 4816891, 4881618, 4989060, 5033627, 3241416, 4160053, 4308004, 4461558, 4565901, 4662547, 4816898, 4882585, 4990629, 5033628, 3248595, 4161235, 4309667, 4461560, 4565902, 4662549, 4817898, 4883073, 4990630, 5033673, 3254499, 4161239, 4311144, 4461580, 4565903, 4662550, 4818896, 4883093, 4990647, 5033679, 3259151, 4162340, 4311159, 4461628, 4565904, 4662551, 4818897, 4883094, 4990648, 5034212, 3272697, 4163622, 4311161, 4461639, 4565905, 4662552, 4818901, 4883096, 4990649, 5034213, 3304525, 4163719, 4312042, 4461640, 4565906, 4662560, 4820191, 488

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2174-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.