[pending] CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Pending LLM rewrite. Source: FDA_DEVICE Z-2184-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Incomplete seals on sterile product
The recalled product
- Product
- CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI 07613327357301
- Lot Numbers: 2934107
- 3695884
- 3813841
- 3963557
- 4293648
- 4660245
- 4816422
- 4937844
- 4984006
- 5024442
- 2964378
- 3695885
- 3813842
- 3963558
- 4294641
- 4665924
- 4816423
- 4937846
- 4984751
Distribution
Distributed nationwide across the United States.