Recall Z-2199-2026
Stryker Sustainability Solutions · initiated April 10, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Codes / lots: UDI00885825011260, Lot Numbers: 4147881, 4760091, 4848398, 4966192, 4995002, 5022496, 5053580, 4470118, 4778468, 4848976, 4966193, 4999115, 5029362, 5063586, 4490754, 4796800, 4855294, 4966194, 5002565, 5029363, 5068369, 4509009, 4815121, 4866012, 4966195, 5002566, 5029364, 5076464, 4527883, 4815122, 4874149, 4969132, 5002873, 5029535, 5085337, 4655115, 4820151, 4883354, 4973129, 5009392, 5029698, 5085818, 4720484, 4826777, 4890964, 4981099, 5014818, 5032181, 4730762, 4845060, 4940777, 4982418, 5017600, 5032182, 4754876, 4846853, 4941142, 4987516, 5018180, 5039989, 4758759, 4847494, 4948941, 4989050, 5018181, 5044865.
Reason for recall
Incomplete seals on sterile product
FDA-determined cause: Process control
Action taken
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 SSSPFA@stryker.com, 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 SSSPFA@stryker.com or Stryker Customer Service at 800-624-4422."
Details
- Recall number
- Z-2199-2026
- Initiated
- April 10, 2026
- Posted by FDA
- May 13, 2026
- Product code
- NLH – Catheter, Recording, Electrode, Reprocessed
- Quantity
- 87 units
- Distribution
- US Nationwide and the countries of Israel and Canada.
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2174-2026 Class II | BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2175-2026 Class II | BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2176-2026 Class II | BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2177-2026 Class II | BARD Dynamic Tip Steerable, Product Number 6DYNTP001;Incomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2178-2026 Class II | BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY…Incomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2179-2026 Class II | BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2180-2026 Class II | BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2181-2026 Class II | BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY…Incomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2182-2026 Class II | BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2183-2026 Class II | BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2184-2026 Class II | CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY…Incomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2185-2026 Class II | CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY…Incomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2186-2026 Class II | Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2187-2026 Class II | Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2188-2026 Class II | Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2189-2026 Class II | Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2190-2026 Class II | Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2191-2026 Class II | Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2192-2026 Class II | Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2193-2026 Class II | Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2194-2026 Class II | Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2195-2026 Class II | Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2196-2026 Class II | Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2197-2026 Class II | Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |
| Z-2198-2026 Class II | Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | 04/10/2026Open, Classified |