The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3044-2026·Announced 2026-09-09

AVID Medical Recalls Halyard Kits Due to Endotoxin Variability

AVID Medical, Inc. is recalling 11,763 Halyard medical convenience kits due to potential unexpected variability in endotoxin levels.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves endotoxin variability, which is a risk-of-harm product issue where injury has not yet been reported.

Plain-English summary

AVID Medical, Inc. is recalling 11,763 Halyard medical convenience kits, including various ENT, spine, and oral surgery packs. The recall was initiated due to a Medicom Urgent Medical Device Recall involving specific lots of Ritmed Neurological Sponges Non-Sterile (Models 55992C to 55998C) found within these kits.

The reason for the recall is the potential for unexpected variability of endotoxin levels on the products. The affected kits were distributed nationwide in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, and GA.

Healthcare facilities and consumers should check their inventory for the specific model and lot numbers listed in the official FDA recall notice Z-3044-2026. If you have these kits, stop using them and contact AVID Medical, Inc. for instructions on return or replacement.

The recalled product

Product
Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCPDH, Model/Item Number (kit) DGSP71; 5) BASIC PACK DR…
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
11,763

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model/Item Number (kit) ACEN89-01
  • UDI/DI 10809160459447
  • Kit Lot Number 1650691
  • UDI/DI 10809160496411
  • Kit Lot Number 1675577
  • Kit Lot Number 1666553
  • Model/Item Number (kit) ACEN89-02
  • UDI/DI 10809160505304
  • Kit Lot Number 1683926
  • Kit Lot Number 1683927
  • Model/Item Number (kit) ALBK51-01
  • UDI/DI 10809160458587
  • Kit Lot Number 1649240
  • Kit Lot Number 1649721
  • UDI/DI 10809160496374
  • Kit Lot Number 1675589
  • Model/Item Number (kit) DGSP71
  • UDI/DI 10809160468036
  • Kit Lot Number 1659332
  • Model/Item Number (kit) DRBS37

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

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