FDA DevicesClass II
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOL...
Published: May 20, 2026Recall ID: Z-2185-2026Category: devicesCountry: US
Reason for Recall / Hazard
Incomplete seals on sterile product
Product Description & Identification
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Additional Source Details
| Field | Value |
|---|---|
| City | Tempe |
| State | AZ |
| Event id | 98708 |
| Address 1 | 1810 W Drake Dr |
| Code info | UDI 07613327357318, Lot Numbers: 3351120, 4756053, 4820613, 4880639, 4937971, 4953195, 4974710, 5002528, 5033775, 5067727, 3351123, 4761288, 4821747, 4880648, 4937973, 4953196, 4975470, 5002529, 5033776, 5069585, 3352961, 4764911, 4821750, 4880654, 4937974, 4953197, 4975472, 5002530, 5034566, 5069588, 3369921, 4766954, 4822911, 4880655, 4937975, 4953198, 4975598, 5002531, 5034567, 5069594, 3369925, 4766956, 4824997, 4880656, 4937976, 4953200, 4977751, 5002855, 5034568, 5069597, 3369927, 4767155, 4825261, 4880657, 4937977, 4953201, 4977753, 5003960, 5034569, 5069599, 3369928, 4772390, 4825262, 4880658, 4937982, 4953202, 4977754, 5004190, 5034570, 5069603, 3425440, 4775105, 4825572, 4880938, 4937983, 4953203, 4977768, 5004192, 5034571, 5069606, 3443600, 4786470, 4825573, 4882690, 4937988, 4953204, 4977769, 5004217, 5034572, 5069609, 3444721, 4793099, 4825574, 4882691, 4937992, 4953205, 4977771, 5004219, 5034573, 5071436, 3446184, 4793102, 4825577, 4882693, 4937996, 4953206, 4977773, 500... [TRUNCATED] |
| Postal code | 85283-4327 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 816 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.