Stryker Daig Livewire Steerable BDB Recall
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 2 units of Daig Livewire Steerable BDB reprocessed electrophysiology catheters due to incomplete seals on sterile products.
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 has initiated a voluntary recall of reprocessed electrophysiology catheters because of incomplete seals on sterile products.
Which Products Are Affected
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER. UDI 00885825007324, Lot Numbers: 4101996, 4175347. A total of 2 units are affected. Distribution was nationwide in the United States and to Israel and Canada.
What You Should Do
Consumers should follow instructions provided by the recalling firm for returning the affected products.
Why This Matters
This is a Class II recall involving a device that may cause temporary or medically reversible adverse health consequences.
Source
FDA recall number Z-2198-2026
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 (770 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.