FDA Medical devices recall ·

Halyard PERC TRAY kit recall

This is an FDA Class I recall — the most serious type.

Recall number
Z-1977-2026
Date
(initiated March 13, 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
6,052 kits
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.

Why was it recalled?

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

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

1. Model Number: SLPC34-01. UDI-DI (Kit Lot Numbers): 10809160450963 (1640169, 1641409, 1641410, 1641411, 1641412, 1641413, 1641414, 1641415, 1645684); 10809160459904 (1649576, 1660882, 1660883, 1660884, 1663896, 1665768). 2. Model Number: SLPC34-02. UDI-DI (Kit Lot Numbers): DHR 108916049515 NAV 10809160511213 (1668809, 1668810, 1668812, 1668813, 1668814, 1668815, 1668816).

Distribution

US distribution to FL, IL, MO, MS, NC, NE, TX.

States: Florida Illinois Missouri Mississippi North Carolina Nebraska Texas

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-1977-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.