Stryker BW Webster Duo-Decapolar Catheter Recall
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Stryker Sustainability Solutions is recalling 154 units of the BW Webster Duo-Decapolar reprocessed electrophysiology catheter due to incomplete seals on sterile product.
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, Devices.
What Happened
Stryker Sustainability Solutions initiated a voluntary recall of the BW Webster Duo-Decapolar reprocessed electrophysiology catheter because of incomplete seals on the sterile product.
Which Products Are Affected
The recall covers 154 units of BW Webster Duo-Decapolar, Product Number D728260RT, distributed nationwide in the United States as well as in Israel and Canada. Affected units carry UDI 00885825011529 and the following lot numbers: 3881385, 4808385, 4854113, 4961672, 4974217, 4988584, 4993237, 5016458, 5021634, 5048549, 3921444, 4822971, 4945780, 4961673, 4979107, 4988587, 4994122, 5016460, 5021635, 5050589, 3998693, 4822986, 4945781, 4961674, 4981313, 4988751, 4994128, 5016461, 5021636, 5053395, 4029481, 4822987, 4953683, 4970070, 4982419, 4988752, 4994180, 5016462, 5021637, 5053396, 4369183, 4824246, 4954241, 4970071, 4982421, 4988753, 4998213, 5016463, 5021639, 5060170, 4369245, 4824248, 4961385, 4970361, 4983569, 4988754, 4998214, 5016464, 5021640, 5060171, 4732484, 4824249, 4961665, 4970362, 4986061, 4988755, 5005259, 5016466, 5021641, 5060172, 4751084, 4828822, 4961666, 4970363, 4986062, 4988756, 5005263, 5017692, 5025098, 5060173, 4796276, 4837793, 4961667, 4970364, 4986063, 4990589, 5005264, 5017935, 5025100, 5060174, 4798223, 4846389, 4961668, 4970365, 4986064, 4990590, 5011152, 5018675, 5025101, 5086587, 4801020, 4853335, 4961669, 4970366, 4986065, 4990591, 5014700, 5018677, 5036101, 5086588, 4801021, 4853336, 4961670, 4970367, 4986067, 4990592, 5014702, 5020792, 5042591, 5086590, 4808376, 4854112, 4961671, 4970368, 4986068, 4992498, 5016457, 5021633, 5045829, 5086592. The recall number is Z-2183-2026 and the recall remains ongoing.
What You Should Do
Consumers should follow instructions provided by Stryker Sustainability Solutions for the recalled devices.
Why This Matters
The recall involves a Class II medical device distributed across the United States, Israel, and Canada.
Source
FDA recall Z-2183-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,989 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.