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

    • 4225215
    • 4653836
    • 4793147
    • 4852429
    • 4986000
    • 5023873
    • 5043553
    • 4280561
    • 4672798
    • 4799184
    • 4852603
    • 4986001
    • 5023874
    • 5043556
    • 4287896
    • 4677462
    • 4799186
    • 4854910
    • 4986002
    • 5023875
    • 5043560
    • 4296580
    • 4677463
    • 4799187
    • 4856657
    • 4997834
    • 5023876
    • 5053722
    • 4309622
    • 4693434
    • 4799188
    • 4860078
    • 5003556
    • 5027296
    • 5059498
    • 4309623
    • 4693435
    • 4799191
    • 4860082
    • 5003557
    • 5027297
    • 5059499
    • 4309846
    • 4693436
    • 4799309
    • 4861298
    • 5003558
    • 5027301
    • 5064680
    • 4374217
    • 4693437
    • 4800061
    • 4861536
    • 5003569
    • 5027406
    • 5064916
    • 4396650
    • 4728693
    • 4800062
    • 4939136
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.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.