Reported May 20, 2026 · Ongoing
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
- BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Lot codes and dates
- UDI 00885825003838
- Lot Numbers
142 of 142 codes
422521546538364793147485242949860005023873504355342805614672798479918448526034986001502387450435564287896467746247991864854910498600250238755043560429658046774634799187485665749978345023876505372243096224693434479918848600785003556502729650594984309623469343547991914860082500355750272975059499430984646934364799309486129850035585027301506468043742174693437480006148615365003569502740650649164396650472869348000624939136
- Amount recalled
- 217 units
This recall covers 26 products
The agency filed one notice per product. You are reading one of them; the other 25 are below.
13 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Incomplete seals on sterile product
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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