Home/Recalls/FDA-Z-2176-2026
FDA DevicesClass II

BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY...

Published: May 20, 2026Recall ID: Z-2176-2026Category: devicesCountry: US

Reason for Recall / Hazard

Incomplete seals on sterile product

Product Description & Identification

BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Additional Source Details

FieldValue
CityTempe
StateAZ
Event id98708
Address 11810 W Drake Dr
Code infoUDI 00885825003135, Lot Numbers: 2268964, 2687510, 3173767, 3269330, 3379246, 4398753, 4876242, 2501717, 2878890, 3231930, 3336473, 3394078, 4780878, 4876243, 2533915, 3137651, 3266358, 3361335, 3454810, 4821709.
Postal code85283-4327
Report date20260520
Product typeDevices
Product quantity28 units
Reason for recallIncomplete seals on sterile product
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260410
Center classification date20260513

Overview

  • Recalling FirmStryker Sustainability Solutions
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide and the countries of Israel and Canada.
Official Agency Alert