Z-3151-2026Class I

Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02

Name: Z-3151-2026 Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02
Creator: AVID Medical, Inc.
Published: 2026-08-10
License: https://open.fda.gov/license/

AVID Medical, Inc. / initiated 2026-08-10 / Open, Classified

FDA source

Recall record

Recall number: Z-3151-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-08-10
Posted: 2026-09-16
Recalling firm: AVID Medical, Inc.
Product: Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
Product code: OGD Custom Anesthesia Tray
Reason for recall: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
FDA root cause: Nonconforming Material/Component
Action: On August 10, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Identify, Segregate, and Quarantine all impacted kits listed. 2. Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative. 3. REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use. 4. Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 6. Complete the attached Recall Response Form and return.
Quantity in commerce: 1640 kits
Distribution: Domestic: IL, NC, VA, WY;
Product codes and lots: Model/Item Number (Kit): DPGE002-02; UDI-DI: 10809160410325; Kit Lots: 1641713, 1641714, 1659697, 1668209; Recalled Sodium Chloride Ampule Lot: AB4003;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3151-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3151-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3152-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3153-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3154-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code OGD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)