Device recall: BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Class II FDA enforcement event 98708. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Incomplete seals on sterile product
Class II, in the words of FDA
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
Stryker Sustainability Solutions started this device recall on 10 Apr 2026. The firm address in the FDA record is in Tempe, AZ. FDA put the recall in Class II. FDA event 98708 has 26 product records. The first FDA enforcement report date is 20 May 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide and the countries of Israel and Canada.
Recalling firm
Stryker Sustainability Solutions, Tempe, AZ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
26 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2174-2026 | BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 3063 units | Class II | Ongoing | 20 May 2026 |
| Z-2175-2026 | BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 61 units | Class II | Ongoing | 20 May 2026 |
| Z-2176-2026 | BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 28 units | Class II | Ongoing | 20 May 2026 |
| Z-2177-2026 | BARD Dynamic Tip Steerable, Product Number 6DYNTP001; | 427 units | Class II | Ongoing | 20 May 2026 |
| Z-2178-2026 | BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER | 90 units | Class II | Ongoing | 20 May 2026 |
| Z-2179-2026 | BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER | Class II | Ongoing | 20 May 2026 | |
| Z-2180-2026 | BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 5 units | Class II | Ongoing | 20 May 2026 |
| Z-2181-2026 | BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 217 units | Class II | Ongoing | 20 May 2026 |
| Z-2182-2026 | BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 44 units | Class II | Ongoing | 20 May 2026 |
| Z-2183-2026 | BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 154 units | Class II | Ongoing | 20 May 2026 |
| Z-2184-2026 | CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 449 units | Class II | Ongoing | 20 May 2026 |
| Z-2185-2026 | CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 816 units | Class II | Ongoing | 20 May 2026 |
| Z-2186-2026 | Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 319 units | Class II | Ongoing | 20 May 2026 |
| Z-2187-2026 | Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 108 units | Class II | Ongoing | 20 May 2026 |
| Z-2188-2026 | Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 19 units | Class II | Ongoing | 20 May 2026 |
| Z-2189-2026 | Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER | 9 units | Class II | Ongoing | 20 May 2026 |
| Z-2190-2026 | Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 24 units | Class II | Ongoing | 20 May 2026 |
| Z-2191-2026 | Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 1352 units | Class II | Ongoing | 20 May 2026 |
| Z-2192-2026 | Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 107 units | Class II | Ongoing | 20 May 2026 |
| Z-2193-2026 | Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 3 units | Class II | Ongoing | 20 May 2026 |
| Z-2194-2026 | Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 10 units | Class II | Ongoing | 20 May 2026 |
| Z-2195-2026 | Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 206 units | Class II | Ongoing | 20 May 2026 |
| Z-2196-2026 | Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 3 units | Class II | Ongoing | 20 May 2026 |
| Z-2197-2026 | Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 458 units | Class II | Ongoing | 20 May 2026 |
| Z-2198-2026 | Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER | 2 units | Class II | Ongoing | 20 May 2026 |
| Z-2199-2026 | Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER | 87 units | Class II | Ongoing | 20 May 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 26Median of the firm: 1
- Events of the firm on the register
- 36
Other events of the firm
Official channels
- FDA enforcement report Z-2174-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 98708. https://recallregister.com/fda/ii/98708/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide and the countries of Israel and Canada.
- What quantity of product is in FDA event 98708?
- The event has 26 product records. The first record gives this quantity:
3063 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.