Stryker Recalls BARD Dynamic Tip Steerable 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 28 units of BARD Dynamic Tip Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging.
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, medical-device.
What Happened
Stryker Sustainability Solutions has initiated a voluntary recall of certain reprocessed electrophysiology catheters because of incomplete seals on the sterile product packaging.
Which Products Are Affected
The recall involves BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER. A total of 28 units are affected, distributed nationwide in the United States as well as in Israel and Canada. The UDI is 00885825003135. Affected lot numbers are: 2268964, 2687510, 3173767, 3269330, 3379246, 4398753, 4876242, 2501717, 2878890, 3231930, 3336473, 3394078, 4780878, 4876243, 2533915, 3137651, 3266358, 3361335, 3454810, 4821709. The recall number is Z-2176-2026 and the classification is Class II. The recalling firm is located in Tempe, Arizona.
What You Should Do
Consumers and healthcare facilities should follow instructions provided by the recalling firm regarding the affected devices.
Why This Matters
The recall affects a small number of reprocessed medical devices distributed across the United States, Israel, and Canada.
Source
FDA Enforcement Report, recall number Z-2176-2026 (https://www.fda.gov)
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 (1,176 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.