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BARD Dynamic XT Deca Steerable, Product Number 201102… recallZ-2178-2026 · Stryker Sustainability Solutions · initiated Apr 10, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Sustainability Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incomplete seals on sterile product

FDA root cause category: Process control

What the company is doing

Stryker issued a Medical Device Recall notice to its consignees on 4/10/2026 via USPS certified mail. The notice explained the product issue, potential risk, and requested the following: "Customer Actions Requested: Our records indicate that you may have distributed, received and/or used the above affected products. 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Please complete the Business Reply Form and return the completed via email to [email protected], or use the QR Code on Attachment B. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility." "For any additional information or questions please reach out to [email protected] or Stryker Customer Service at 800-624-4422."

Recall details

Recall number
Z-2178-2026
Status
Open, Classified
Initiated by the company
Apr 10, 2026
Posted by the FDA
May 13, 2026
Recalling firm
Stryker Sustainability Solutions
Quantity
90 units
Product code
NLH
FDA submissions
K012708, K030187, K052603, K100254
Distribution
US Nationwide and the countries of Israel and Canada.

Product description

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI 00885825003869, Lot Numbers: 3975235, 4253785, 4277547, 4297459, 4656095, 4818154, 4972266, 4065815, 4253786, 4277548, 4297460, 4656096, 4818155, 5032390, 4180953, 4253791, 4296975, 4363237, 4717623, 4818156, 5032392, 4223973, 4254918, 4296977, 4404427, 4717624, 4831929, 5032393, 4253773, 4254919, 4296978, 4481136, 4717625, 4831931, 5032394, 4253774, 4254921, 4296979, 4494845, 4742015, 4836645, 5032395, 4253775, 4254922, 4296980, 4542475, 4742017, 4836646, 5032710, 4253778, 4254923, 4296981, 4544586, 4742018, 4858708, 5055855, 4253779, 4277541, 4296982, 4545898, 4788864, 4858709, 5055858, 4253782, 4277544, 4297456, 4656082, 4788865, 4881310, 5073042, 4253783, 4277545, 4297457, 4656093, 4788866, 4967746, 5079052, 4253784, 4277546, 4297458, 4656094, 4807750, 4972265.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

39 devices cleared under K012708, K030187, K052603, K100254 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98708).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page