Recall Ledger

Haylard BASIC BIOPSY TRAY recall (AVID Medical, Inc.)

Medical deviceClass IOngoing

Summary: AVID Medical, Inc. is recalling Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;. Reason: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

What is being recalled

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

Why

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

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

Domestic: IL, NC, VA, WY; (states named: Illinois, North Carolina, Virginia, Wyoming)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3153-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass I
StatusOngoing
Recall startedAugust 10, 2026
ReportedSeptember 23, 2026
CompanyAVID Medical, Inc.
Company locationToano, VA, United States
Initiated byVoluntary: Firm initiated
Quantity240 kits

More recalls from AVID Medical, Inc. · all medical device recalls · recalls from August 2026

Official FDA record