FDA-Device2026-09-23Class IPACKAGING DEFECT
AVID Medical Haylard 18G Single Shot EPI Tray recalled for sterility and quality issues
What this means
AVID Medical's Haylard 18G Single Shot EPI Tray kits (model DPGE002-02) may contain Sodium Chloride ampules with potential sterility and product quality issues. The ampules were subject to a recall by Spectra Medical. Approximately 1,640 kits with specific lot numbers have been identified.
- Check if you have a Haylard 18G EPI Tray kit with lot numbers 1641713, 1641714, 1659697, or 1668209.
- Do not use kits with these lot numbers.
- Contact AVID Medical or your supplier for instructions on return or replacement.
The agency's original wording
Hazard
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Intended for
Adults
Illnesses reported
None reported
Sold states
Domestic: IL, NC, VA, WY;
Affected count
1640 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3151-2026More AVID Medical recalls
- FDA-Device2026-09-30Halyard IV START KIT NON-STERILE recalled for open or incomplete applicator seal
- FDA-Device2026-09-30Halyard IV START KIT recalled for potentially unsealed ChloraPrep applicator packaging
- FDA-Device2026-09-30Halyard IV START KIT recalled for potential Aspergillus contamination
- FDA-Device2026-09-23AVID Medical Haylard biopsy kit recalled for sterility and quality issues with sodium chloride ampules
- FDA-Device2026-09-09AVID Medical neurological surgical kits recalled for endotoxin variability in sponges
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