Device recall
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
- Recall number
- Z-3151-2026
- Event id
- 99758
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- AVID Medical, Inc.
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Sep 16, 2026
- Product code
- OGD
- Device type
- Custom Anesthesia Tray
- Reason
- Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Root cause
- Nonconforming Material/Component
- Quantity
- 1640 kits
- Code info
- Model/Item Number (Kit): DPGE002-02; UDI-DI: 10809160410325; Kit Lots: 1641713, 1641714, 1659697, 1668209; Recalled Sodium Chloride Ampule Lot: AB4003;
- Distribution
- Domestic: IL, NC, VA, WY;
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States