FDAClass IIMay 20, 2026

BW Webster Duo-Decapolar recall

BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Why was BW Webster Duo-Decapolar recalled?

Incomplete seals on sterile product

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI 00885825011529, 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.

Product
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Recalling firm
Stryker Sustainability Solutions
Quantity
154 units
Distribution
US Nationwide and the countries of Israel and Canada.
Recall date
May 20, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls