Stryker Sustainability Solutions Recalls Reprocessed Electrophysiology Catheter
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Stryker Sustainability Solutions is recalling 816 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 2, 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 initiated a voluntary 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 affects 816 units of CS Uni-Directional w Auto ID (Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER) distributed nationwide in the United States as well as in Israel and Canada. The UDI is 07613327357318. Affected lot numbers include: 3351120, 4756053, 4820613, 4880639, 4937971, 4953195, 4974710, 5002528, 5033775, 5067727 and many additional lots (full list available in FDA recall Z-2185-2026). The recall number is Z-2185-2026 and the recall initiation date is April 10, 2026. The classification is Class II and the status is ongoing.
What You Should Do
Consumers and healthcare facilities should immediately stop using the affected devices and follow the instructions provided by Stryker Sustainability Solutions or the FDA for return or disposal.
Why This Matters
The incomplete seals on sterile packaging may compromise product sterility, posing a risk of infection or other adverse health consequences.
Source
FDA Recall Z-2185-2026 - Stryker Sustainability Solutions, Tempe, AZ
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 (1,284 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.