RecallRadar

FDA Device recall Z-2178-2026

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

On 2026-05-20 the FDA classified a Class II recall of BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER by Stryker Sustainability Solutions, citing incomplete seals on sterile product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2178-2026
ClassificationClass II
Statusongoing
Initiated2026-04-10
Published2026-05-20
Last updated2026-09-13 11:58 UTC
CompanyStryker Sustainability Solutions
DistributionUS

Product

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Reason

Incomplete seals on sterile product

Identifiers

code_info
UDI 00885825003869, Lot Numbers: 3975235, 4253785, 4277547, 4297459, 4656095, 4818154, 4972266, 4065815, 4253786, 4277…UDI 00885825003869, Lot Numbers: 3975235, 4253785, 4277547, 4297459, 4656095, 4818154, 4972266, 4065815, 4253786, 4277548, 4297460, 4656096, 4818155, 5032390, 4180953, 4253791, 4296975, 4363237, 4717623, 4818156, 5032392, 4223973, 4254918, 4296977, 4404427, 4717624, 4831929, 5032393, 4253773, 4254919, 4296978, 4481136, 4717625, 4831931, 5032394, 4253774, 4254921, 4296979, 4494845, 4742015, 4836645, 5032395, 4253775, 4254922, 4296980, 4542475, 4742017, 4836646, 5032710, 4253778, 4254923, 4296981, 4544586, 4742018, 4858708, 5055855, 4253779, 4277541, 4296982, 4545898, 4788864, 4858709, 5055858, 4253782, 4277544, 4297456, 4656082, 4788865, 4881310, 5073042, 4253783, 4277545, 4297457, 4656093, 4788866, 4967746, 5079052, 4253784, 4277546, 4297458, 4656094, 4807750, 4972265.

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-2178-2026%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.