FDA DevicesClass II
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOG...
Published: May 20, 2026Recall ID: Z-2174-2026Category: devicesCountry: US
Reason for Recall / Hazard
Incomplete seals on sterile product
Product Description & Identification
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Additional Source Details
| Field | Value |
|---|---|
| City | Tempe |
| State | AZ |
| Event id | 98708 |
| Address 1 | 1810 W Drake Dr |
| Code info | 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... [TRUNCATED] |
| Postal code | 85283-4327 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 3063 units |
| Reason for recall | Incomplete seals on sterile product |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260410 |
| Center classification date | 20260513 |
Overview
- Recalling FirmStryker Sustainability Solutions
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide and the countries of Israel and Canada.