Device recall

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

FDA recall source

Recall number

Z-3153-2026

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

LRO

Device type

General Surgery 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

240 kits

Code info

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

Distribution

Domestic: IL, NC, VA, WY;

Voluntary or mandated

Voluntary: Firm initiated

Location

Toano, VA, United States