CS Uni-Directional w Auto ID — Class II medical device recall Z-2185-2026
Ongoing recall by Stryker Sustainability Solutions, reported 2026-05-20, distributed nationwide. Incomplete seals on sterile product
| Recall number | Z-2185-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2026-04-10 |
| Classified | 2026-05-13 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IL |
| Quantity | 816 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 07613327357318 |
| Lot numbers | 3351120, 3351123, 3352961, 3369921, 3369925, 3369927, 3369928, 3425440, 3443600, 3444721, 3446184, 3476984, 3485190, 3485192, 3610789, 3662960, 3689125, 3689126, 3697347, 3697352, 3703895, 3703898, 3703899, 3715609, 3715640, 3729296, 3729298, 3976771, 3979774, 4020150, 4022512, 4050955, 4086384, 4086387, 4481221, 4614498, 4614502, 4649179, 4650571, 4663387 and 460 more |
Product
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason for recall
Incomplete seals on sterile product
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2185-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.