Stryker Recalls BARD Dynamic Tip Steerable Electrophysiology Catheter
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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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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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 ↗
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