FDA Medical devices recall ·
Haylard BASIC BIOPSY TRAY recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-3153-2026
- Date
- (initiated August 10, 2026)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 240 kits
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
Why was it recalled?
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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;
States: Illinois North Carolina Virginia Wyoming
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-3153-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.