Quick Facts at a Glance
- Recall Date
- April 10, 2026
- Hazard Level
- HIGH
- Brand
- Stryker Sustainability Solutions
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Stryker Sustainability Solutions
- Model numbers
- UDI 00885825003838, Lot Numbers: 4225215, 4653836, 4793147, 4852429, 4986000, 5023873, 5043553 +12 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 10, 2026
Reported by FDA DEVICE
May 20, 2026
RecallRadar source check
May 27, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Incomplete seals on sterile product
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Sustainability Solutions or your healthcare provider for instructions
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Full Description
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER. Reason: Incomplete seals on sterile product. Classification: Class II. Quantity: 217 units. Distribution: US Nationwide and the countries of Israel and Canada.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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