Reported May 20, 2026 · Ongoing
CS Uni-Directional w Auto ID, Product Number D135304; 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 D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Lot codes and dates
- UDI 07613327357318
- Lot Numbers
729 of 729 codes
335112047560534820613488063949379714953195497471050025285033775506772733511234761288482174748806484937973495319649754705002529503377650695853352961476491148217504880654493797449531974975472500253050345665069588336992147669544822911488065549379754953198497559850025315034567506959433699254766956482499748806564937976495320049777515002855503456850695973369927476715548252614880657493797749532014977753500396050345695069599
- Amount recalled
- 816 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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