RecallRadar
FDA · Medical devicesClass I

AVID Medical, Inc. medical device recall: Haylard 18G SINGLE SHOT EPI TRAY

Sterility concerns

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
99758
Recall initiated
Aug 10, 2026
Classified by FDA
Sep 16, 2026
Posted in Enforcement Report
Sep 23, 2026
Recalling firm
AVID Medical, Inc.
Firm location
Toano, VA, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
4

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Aug 10, 2026. FDA classified it 37 days later, on Sep 16, 2026. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: Domestic: IL, NC, VA, WY; AVID Medical, Inc. has 28 recalls in our records.

Recalled products (4)

  • Z-3151-2026 Class I Ongoing

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

    Codes / lots: Model/Item Number (Kit): DPGE002-02; UDI-DI: 10809160410325; Kit Lots: 1641713, 1641714, 1659697, 1668209; Recalled Sodium Chloride Ampule Lot: AB4003;

    Quantity: 1640 kits

  • Z-3152-2026 Class I Ongoing

    Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;

    Codes / lots: Model/Item Number (Kit): BMCN001-05; UDI-DI: 10809160455128; Kit Lots: 1703122, 1707656, 1708053; Recalled Sodium Chloride Ampule Lot: AB5002;

    Quantity: 80 kits

  • Z-3153-2026 Class I Ongoing

    Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;

    Codes / lots: Model/Item Number (Kit): PM415; UDI-DI: 10809160322154; Kit Lots: 1652485, 1656642, 1667835, 1676219, 1682251, 1691940; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;

    Quantity: 240 kits

  • Z-3154-2026 Class I Ongoing

    Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;

    Codes / lots: Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;

    Quantity: 340 kits

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 99758
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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