BARD EP XT Steerable Catheter Recall Issued by Stryker
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Stryker Sustainability Solutions is recalling 44 units of BARD EP XT Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile packaging.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 3, 2026 and geographically references United States, Israel, Canada. 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 initiated a voluntary recall of BARD EP XT Steerable reprocessed electrophysiology catheters because of incomplete seals on the sterile product.
Which Products Are Affected
The recall involves BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER. A total of 44 units are affected, distributed nationwide in the United States as well as in Israel and Canada. Affected lot numbers are: 4573219, 4869696, 4992244, 4999900, 5025367, 5038410, 5085389, 4804556, 4971805, 4992245, 4999902, 5032111, 5043783, 4804558, 4971806, 4992246, 5012684, 5032112, 5043784, 4809474, 4990763, 4992247, 5012708, 5032113, 5043785, 4829451, 4990764, 4993772, 5012709, 5033926, 5043787, 4835199, 4990769, 4997966, 5012711, 5033927, 5056579, 4841812, 4992243, 4998135, 5012726, 5033928, 5056828. The UDI is 00885825003739. This is FDA Recall Number Z-2182-2026, a Class II recall initiated on April 10, 2026.
What You Should Do
Consumers and healthcare facilities should follow the recalling firm's instructions for returning the affected products. Contact Stryker Sustainability Solutions for return, refund, or additional information.
Why This Matters
The incomplete seals on sterile packaging may compromise product sterility for these reprocessed electrophysiology catheters distributed across the US and internationally.
Source
FDA Enforcement Report, Recall Number Z-2182-2026
Original source: FDA Official Notice ↗
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