Surgical forceps and clamps recalled due to potential metal flake contamination
AVID Medical is recalling Halyard ENT surgical convenience kits due to potential metal flakes from forceps and clamps that could enter a patient's surgical site. Metal flakes may cause local or foreign body reactions during surgery.
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: This is an FDA Class II recall of surgical instruments with potential for patient harm. The hazard—loose metal flakes that could contaminate surgical sites and cause local or foreign body reactions—represents a significant risk of harm to patients undergoing procedures with these instruments, though no illnesses or injuries have been reported to date.
Plain-English summary
AVID Medical, Inc. is recalling Halyard ENT Medical convenience kits (Model VMED011-01) nationwide. The kits contain sponge forceps and towel clamps that may have small loose metal flakes.
The metal flakes could potentially detach from the forceps and clamps during use and enter a patient's surgical site undetected. If metal flakes enter the surgical site, they may cause local tissue reactions or foreign body reactions.
The recalled product
- Product
- Halyard ENT - Medical convenience kits Model Number: VMED011-01
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 21
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: 10809160334980 Lot Number: 1582596
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 73 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 73 products in this recall →Related recalls
Same manufacturer · AVID Medical, Inc.
See all →- ModerateAvid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAvid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Urology Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Same hazard · foreign body contamination
See all →- HighHilal Embolization Microcoils Recalled for Unintended Stainless-Steel Cannula
FDA (Devices) · 2022-06-15
- HighMaquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
FDA (Devices) · 2019-07-03
- HighMaquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
FDA (Devices) · 2019-07-03
- SevereSmith & Nephew Recalls Reflection Dead Blow Mallets Due to Weld Cracks
FDA (Devices) · 2017-01-18
Similar recalls
- HighAVID Medical Recalls Halyard Kits Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- ModerateAvid Medical Recalls Shoulder Arthroscopy Kits with Foreign Material
FDA (Devices) · 2018-03-07
- ModerateHalyard SUTURE PACK CABG Cardiovascular Kit Needle Coating Issue
FDA (Devices) · 2025-05-21
- ModerateAvid Medical Recalls Obstetrical Packs With Foreign Material in Needles
FDA (Devices) · 2018-03-07
- ModerateHalyard CHRIST SUTURE KIT surgical needles coating defect recall
FDA (Devices) · 2025-05-21
- HighAVID Medical Recalls Halyard Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-09-09