Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling 154 units of BW Webster Duo-Decapolar reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with a risk-of-harm hazard (compromised sterility on an invasive electrophysiology catheter). The source text does not report any illnesses or injuries, and no deaths are mentioned. The defect—incomplete seals—creates a potential for infection or other adverse events, placing it at High severity per the rubric.
Plain-English summary
Stryker Sustainability Solutions is recalling BW Webster Duo-Decapolar, Product Number D728260RT, a reprocessed electrophysiology catheter. The recall affects 154 units distributed in the United States, Israel, and Canada.
The catheters are being recalled because of incomplete seals on the sterile product packaging. This defect may compromise the sterility of the device.
The affected product can be identified by UDI 00885825011529 and multiple lot numbers provided in the recall notice. Hospitals and healthcare facilities that have received these catheters should contact Stryker Sustainability Solutions for instructions on handling affected inventory.
Consumers and healthcare providers with questions or concerns should reach out to the manufacturer for additional information and guidance on next steps.
The recalled product
- Product
- BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 154
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI 00885825011529
- Lot Numbers: 3881385
- 4808385
- 4854113
- 4961672
- 4974217
- 4988584
- 4993237
- 5016458
- 5021634
- 5048549
- 3921444
- 4822971
- 4945780
- 4961673
- 4979107
- 4988587
- 4994122
- 5016460
- 5021635
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by Stryker Sustainability Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 26 products in this recall →Related recalls
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Similar recalls
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