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 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-devices.
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 ↗
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 (1,454 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.