CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report
Daig Livewire Steerable, Product Number recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable, Product Number 401923, distributed nationwide in the US. The recall was initiated on 10 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2196-2026
- FDA event ID
- 98708
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Apr 2026
- FDA classified
- 13 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 10 Apr 2026 | Recall initiated by company | |
| 13 May 2026 | Classified by FDA | +33 days |
| 20 May 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incomplete seals on sterile product
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it was distributed
US Nationwide and the countries of Israel and Canada.
Questions about this recall
Why was it recalled?
Incomplete seals on sterile product
Which lots are affected?
UDI 00885825007331. Lot Numbers: 3557411, 3702628, 4498116.
Where was it sold?
US Nationwide and the countries of Israel and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
25 other products · FDA event 98708This product is part of a recall event; the main page for the event is BARD Dynamic Tip Steerable, Product Number 6DYNTP001 recalled.
More recalls from Stryker Sustainability Solutions
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |