RecallReported October 14, 2026
Class II recall by Stryker Sustainability Solutions
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
FDA's enforcement report of October 14, 2026 lists a Class II recall by Stryker Sustainability Solutions of Tempe, AZ. Product: BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007. Status: Ongoing.
On the record
- Recalling firm
- Stryker Sustainability Solutions
- Location
- Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-0085-2027
- Product type
- Devices
- Recall initiated
- 2026-08-18
- Reported by FDA
- 2026-10-14
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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