Stryker CS Uni-Directional Catheter Recall Issued
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Stryker Sustainability Solutions is recalling 449 units of its CS Uni-Directional w Auto ID reprocessed electrophysiology catheter due to incomplete seals on sterile product.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Stryker Sustainability Solutions has initiated a recall of the CS Uni-Directional w Auto ID reprocessed electrophysiology catheter because of incomplete seals on the sterile product.
Which Products Are Affected
The recall covers CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER. A total of 449 units distributed nationwide in the US as well as in Israel and Canada are affected. The UDI is 07613327357301 and includes numerous lot numbers beginning with 2934107 through 5085978.
What You Should Do
Consumers and healthcare facilities should follow the recalling firm's instructions for returning or handling affected products. Contact Stryker Sustainability Solutions for return and refund information.
Why This Matters
The recall involves a Class II medical device distributed across the United States, Israel, and Canada.
Source
FDA recall number Z-2184-2026 (ongoing Class II recall initiated April 10, 2026).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (989 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.