Stryker recalls CS Uni-Directional w Auto ID catheters (Product Number D135304) with incomplete sterile seals. Check UDI 07613327357318 and Lot Numbers listed for affected units. Stop using if you have this model.
Incomplete seals on sterile product
Stryker is recalling CS Uni-Directional w Auto ID electrocardiography catheters due to incomplete sterile seals. This could lead to infection or contamination during medical procedures. Affected units have specific UDI and Lot Numbers listed in the recall.
Incomplete seals on the sterile product could allow contamination or infection during medical procedures. This is a risk for patients undergoing electrophysiology treatments where the catheter is inserted into the body.
Healthcare professionals using these catheters for electrophysiology procedures are most at risk. Patients receiving these catheters during surgery or medical treatment may be affected.
Check for Product Number D135304 and UDI 07613327357318. Affected units have Lot Numbers listed in the recall (e.g., 3351120, 4756053, 4820613, etc.).
Look for Product Number D135304 and UDI 07613327357318 on the catheter packaging or label.
The recall does not specify an immediate stop-use requirement. Check the Product Number and UDI to confirm if your unit is affected.
If your catheter matches the Product Number D135304 and UDI 07613327357318 with one of the listed Lot Numbers, contact Stryker for instructions.
Check the Product Number D135304 and UDI 07613327357318 on the catheter. Affected units have specific Lot Numbers listed in the recall.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2185-2026 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2185-2026 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
