BARD Dynamic Deca Steerable Catheter Recall
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Stryker Sustainability Solutions is recalling 3,063 units of BARD Dynamic Deca Steerable 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 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 sterile product.
Which Products Are Affected
The recall involves BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER. A total of 3,063 units are affected. The product has UDI 00885825003845 and includes numerous lot numbers distributed nationwide in the United States as well as in Israel and Canada. The recall number is Z-2174-2026 and was initiated on April 10, 2026. The recalling firm is located in Tempe, AZ.
What You Should Do
Consumers and healthcare facilities should follow the instructions provided by Stryker Sustainability Solutions for returning or handling the affected devices. Contact the firm for return, refund, or additional guidance.
Why This Matters
The incomplete seals may compromise product sterility, posing a potential risk of infection or other adverse events for patients.
Source
FDA recall number Z-2174-2026 (Class II, ongoing).
Original source: FDA Official Notice ↗
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