Stryker Sustainability Solutions recalls BARD EP XT Decapolar Steerable
- Recalling company
- Stryker Sustainability Solutions
- Product
- BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Reason
- Incomplete seals on sterile product
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 10, 2026
- Reported
- May 20, 2026
- Distribution
- US Nationwide and the countries of Israel and Canada.
- Status
- Ongoing
- Quantity
- 217 units
- Lot / codes
- UDI 00885825003838, Lot Numbers: 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, 5004167, 5027407, 5071434, 4458557, 4728695, 4800113, 4953662, 5004181, 5027571, 5072250, 4479919, 4733707, 4801993, 4953663, 5007874, 5028963, 5073207, 4497169, 4755043, 4801994, 4963413, 5009259, 5030330, 5073552, 4507933, 4755045, 4807495, 4963414, 5013933, 5031863, 5083312, 4510607, 4755046, 4808706, 4963418, 5013934, 5032745, 5083313, 4551972, 4755047, 4808707, 4966281, 5013949, 5038102, 5084295, 4566389, 4762910, 4809527, 4968920, 5013956, 5038314, 5085197, 4585687, 4773741, 4811620, 4968921, 5016583, 5038317, 4600586, 4777739, 4811622, 4974743, 5016616, 5038318, 4613364, 4786928, 4811625, 4976214, 5018038, 5038321, 4613429, 4786931, 4829506, 4976215, 5018718, 5038782, 4614815, 4793146, 4829507, 4985998, 5020889, 5043552.
- Company location
- Tempe, AZ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2181-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2181-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.