CLASS II ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report
Halyard Suture Pack Cabg recalled by AVID Medical
Avid Medical is recalling Halyard Suture Pack Cabg, distributed nationwide in the US. The recall was initiated on 31 Mar 2025 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-1742-2025
- FDA event ID
- 96731
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Mar 2025
- FDA classified
- 9 May 2025
- Reported
- 21 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 31 Mar 2025 | Recall initiated by company | |
| 9 May 2025 | Classified by FDA | +39 days |
| 21 May 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Product as listed by the FDA
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Where it was distributed
US Nationwide distribution in the states of IL & LA.
Questions about this recall
Why was it recalled?
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Which lots are affected?
Model No. SILV800-01; UDI: 10809160450680; Lot Code: Lot: 1642454; Exp: 2/4/2028.
Where was it sold?
US Nationwide distribution in the states of IL & LA.
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
2 other products · FDA event 96731This product is part of a recall event; the main page for the event is Halyard Christ Suture Kit recalled by AVID Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Halyard Christ Suture Kit recalled by AVID Medical | Avid Medical | Other | Nationwide | |
| CLASS II | Halyard Rapides E-pack recalled by AVID Medical | Avid Medical | Other | Nationwide |
More recalls from Avid Medical
All 184| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard Total Joint recalled by AVID Medical | Avid Medical | Foreign Material | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |