Halyard IVR Vascular Pack Surgical Instruments Recalled for Loose Metal Components
AVID Medical is recalling Halyard IVR Vascular Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site.
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 involving loose metal contamination in surgical instruments with risk of foreign body reactions in patients. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3). No illnesses or injuries have been reported in the source.
Plain-English summary
AVID Medical, Inc. is recalling Halyard IVR VASCULAR PACK (Model Number: VAST027-08) medical convenience kits nationwide. The recall affects sponge forceps and towel clamps in kits distributed with Lot Numbers 1608916 and 1608917.
The recalled components may shed small loose metal flakes that could detach and enter a patient's surgical site undetected. If metal flakes enter the surgical field, they may cause local tissue reactions or foreign body reactions.
Healthcare providers and surgical facilities that received these kits should contact AVID Medical for further instructions regarding the recalled products and lots.
The recalled product
- Product
- Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 64
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 (2)
- GTIN: 10809160416303 Lot Number: 1608916
- 1608917
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
See all →- ModerateIntegrated Medcraft Recalls FORWARD Gunshot Wound Kits Due to Sterile Pad Degradation
FDA (Devices) · 2026-10-21
- HighHortex Mieszanka 9 Spring Vegetable Mix Recalled for Potential Glass Contamination
FDA (Food) · 2026-03-18
- HighShort blunt tip sealers recalled over residual material that may dislodge
FDA (Devices) · 2025-11-19
- HighSmall jaw sealers recalled over residual material that may dislodge
FDA (Devices) · 2025-11-19
- HighReprocessed vessel sealers recalled over residual material that may dislodge
FDA (Devices) · 2025-11-19
Similar recalls
- 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
- ModerateAvid Medical Recalls Shoulder Arthroscopy Kits with Foreign Material
FDA (Devices) · 2018-03-07
- HighAVID Medical Recalls Halyard Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- HighHalyard RAPIDES E-PACK Cardiovascular Procedure Kit Surgical Needle Coating Issue
FDA (Devices) · 2025-05-21
- ModerateHalyard CHRIST SUTURE KIT surgical needles coating defect recall
FDA (Devices) · 2025-05-21