Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Recall Summary Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheters (CS Uni-Directional with Auto ID, Product Number D135303) distributed nationwide in the US, as well as in Canada and Israel, due to incomplete seals on the sterile packaging. The incomplete seals could potentially allow the sterile product to become contaminated. This is classified as a Class II recall, meaning the product could cause adverse health effects or serious injury.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Reason
- Incomplete seals on sterile product
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide and the countries of Israel and Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a679bbd5-4757-44df-b1c6-42dfe1e08f1a