CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report
Halyard, Head And Neck Tray recalled by AVID Medical
Avid Medical is recalling Halyard, Head And Neck Tray, distributed in Georgia, Illinois, Maryland, Nebraska. The recall was initiated on 14 Nov 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-0930-2026
- FDA event ID
- 98045
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Nov 2025
- FDA classified
- 15 Dec 2025
- Reported
- 24 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 14 Nov 2025 | Recall initiated by company | |
| 15 Dec 2025 | Classified by FDA | +31 days |
| 24 Dec 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for incomplete seal on header bag.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Where it was distributed
US distribution to GA, IL, NE, MD.
Questions about this recall
Why was it recalled?
Potential for incomplete seal on header bag.
Which lots are affected?
Catalog Number: EURO016-09. UDI-DI: 10809160461198. Lot Number: 1655501 Expiration Date: 3/31/2027.
Where was it sold?
US distribution to GA, IL, NE, MD.
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
4 other products · FDA event 98045This product is part of a recall event; the main page for the event is Halyard, Midtown General Arteriogram recalled by AVID Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Halyard, Midtown General Arteriogram recalled by AVID Medical | Avid Medical | Packaging Defects | 4 states | |
| CLASS II | Halyard, EP LAB PK recalled by AVID Medical | Avid Medical | Packaging Defects | 4 states | |
| CLASS II | Halyard, Major Pack recalled by AVID Medical | Avid Medical | Packaging Defects | 4 states | |
| CLASS II | Halyard, General Laparoscopy Pack recalled by AVID Medical | Avid Medical | Packaging Defects | 4 states |
More recalls from Avid Medical
All 207| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
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Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |