The Recall Desk
HighFDA (Devices)·Z-0424-2025·Announced 2024-11-20

Halyard Vaginal Gyn Pack Recalled Due to Loose Metal Flakes Risk

AVID Medical is recalling the Halyard MAJOR VAGINAL GYN PACK due to sponge forceps and towel clamps that may shed loose metal flakes. These flakes could enter a surgical site undetected, causing local reactions or foreign body reactions.

What this means for you

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: This is a Class II medical device recall involving a theoretical risk of harm—metal flakes that could enter a surgical field. No illnesses or injuries have been reported in the source text, so per the severity rubric, the score is at most 3 (High) for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

AVID Medical, Inc. is recalling the Halyard MAJOR VAGINAL GYN PACK (Model SAMM021-11, Lot 1583045) nationwide because the sponge forceps and towel clamps included in the kit may develop loose metal flakes.

The metal flakes could potentially detach from the components during use. If these flakes enter a patient's surgical site undetected, they may cause local reactions or foreign body reactions.

The recall affects gynecological examination kits distributed nationwide in the United States.

The recalled product

Product
Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • metal-flakes
  • foreign-body

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 (1)

  • GTIN: 10809160381991 Lot Number: 1583045

Distribution

Distributed nationwide across the United States.

Related recalls

Same category