Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling 217 units of BARD EP XT Decapolar Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
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 an FDA Class II recall of a sterile medical device with a structural integrity defect (incomplete seals) that creates a risk of harm through loss of sterility. No reported illnesses or injuries are mentioned in the source text, but the potential for serious adverse outcomes from compromised sterility in an implantable electrophysiology catheter justifies a High severity classification.
Plain-English summary
Stryker Sustainability Solutions is recalling BARD EP XT Decapolar Steerable reprocessed electrophysiology catheters (Product Number 201007, UDI 00885825003838) due to incomplete seals on sterile product packaging. A total of 217 units across multiple lot numbers are affected.
The product was distributed nationwide in the United States and to Israel and Canada. Incomplete seals on sterile products can compromise the sterility assurance of the device.
Patients and healthcare providers who have received or are using affected units should contact Stryker Sustainability Solutions for instructions on how to proceed. Healthcare facilities should verify their inventory against the affected lot numbers and follow proper handling and disposal procedures.
The recalled product
- Product
- BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 217
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 00885825003838
- Lot Numbers: 4225215
- 4653836
- 4793147
- 4852429
- 4986000
- 5023873
- 5043553
- 4280561
- 4672798
- 4799184
- 4852603
- 4986001
- 5023874
- 5043556
- 4287896
- 4677462
- 4799186
- 4854910
- 4986002
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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FDA (Devices) · 2026-10-14
- HighStryker Recalls Reprocessed Diagnostic Electrophysiology Catheters and Cables
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- HighStryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach
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- HighStryker Diagnostic Electrophysiology Catheters Recalled for Testing Failure
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