Reported May 20, 2026 · Ongoing
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
- CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Lot codes and dates
- UDI 07613327357301
- Lot Numbers
436 of 436 codes
293410736958843813841396355742936484660245481642249378444984006502444229643783695885381384239635584294641466592448164234937846498475150244433369649369588638138433963559432045146659264820652493785049858105025866341403036958893813844396356143204544677505482414049378534985813502590834879573695898381408439635654320584468357448241414937876498581450259093487959369589938140893963923432058546904604824142493788649858195025913
- Amount recalled
- 449 units
This recall covers 26 products
The agency filed one notice per product. You are reading one of them; the other 25 are below.
13 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Incomplete seals on sterile product
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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