Agency classClass IIOur severity:Severe FDA (Devices)·Z-2178-2026·Announced 2026-05-20

BARD Dynamic XT Deca Steerable electrophysiology catheter Class II recall

Stryker Sustainability Solutions is recalling 90 units of the BARD Dynamic XT Deca Steerable electrophysiology catheter due to incomplete seals on the sterile product.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a sterile medical device with a defect (incomplete seals) that creates a risk of infection. Class II recalls with risk-of-harm products where the hazard involves sterility compromise of invasive medical devices meet the Severe threshold.

Plain-English summary

Stryker Sustainability Solutions is recalling 90 units of the BARD Dynamic XT Deca Steerable, Product Number 201102, a reprocessed electrophysiology catheter. The recall affects product with UDI 00885825003869 and the 80 specific lot numbers listed by the FDA. The issue identified is incomplete seals on the sterile product.

The recalled units were distributed nationwide in the United States and to the countries of Israel and Canada. Incomplete seals on a sterile medical device could compromise sterility and create a potential risk of infection.

Customers who have received affected units should contact Stryker Sustainability Solutions. Healthcare facilities should identify and quarantine affected inventory by lot number and cease use of the recalled product.

The recalled product

Product: BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Manufacturer: Stryker Sustainability Solutions
Category: Medical Device — Electrophysiology Catheter
Hazard: sterile-seal-compromise
infection-risk
Affected units: 90

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI 00885825003869
Lot Numbers: 3975235
4253785
4277547
4297459
4656095
4818154
4972266
4065815
4253786
4277548
4297460
4656096
4818155
5032390
4180953
4253791
4296975
4363237
4717623

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 26 recalled by Stryker Sustainability Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 26 products in this recall →

Same manufacturer · Stryker Sustainability Solutions

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Same hazard · sterile seal compromise