Recall Z-0085-2027 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
| Date | Oct 5, 2026 (initiated Aug 18, 2026) |
| Status | Open, Classified |
| Reason | Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter. |
| Root cause | Packaging process control |
| Action | On 8/18/2026, the recall notice was mailed to the customer asking them to do the following: 1) Inform individuals within your organization who need to be aware of this action. 2) Quarantine and return affected product to the firm. 4) Complete and return the Business Reply Form via email to SSSPFA@stryker.com Questions can be directed to the firm via email, SSSPFA@stryker.com, or via phone 800-624-4422. |
| Quantity | 10 |
| Distribution | US Nationwide distribution in the state of NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER Alliance Medical, Inc., Sep 24, 2003 |