Halyard Biopsy Pack surgical instruments recalled due to loose metal flakes
AVID Medical is recalling Halyard BIOPSY PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps. Metal flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.
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: Class II medical device with potential for foreign body contamination in surgical sites, but no reported injuries or illnesses. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' scoring High (3).
Plain-English summary
AVID Medical, Inc. is recalling Halyard BIOPSY PACK surgical convenience kits (Model Number VANW019-04, Lot Number 1609032) distributed nationwide in the United States. The recall was issued by the U.S. Food and Drug Administration.
The sponge forceps and towel clamps in these kits may have small, loose metal flakes that could detach from the components. If these metal flakes enter a patient's surgical site undetected during a procedure, they could cause local tissue reactions or foreign body reactions.
The affected lot (1609032) consisted of 88 units. Consumers and healthcare facilities should discontinue use of this product immediately and contact AVID Medical for replacement or return instructions.
If you have this product, do not use it and contact the manufacturer or your healthcare provider with questions about your safety.
The recalled product
- Product
- Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 88
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: 10809160379462 Lot Number: 1609032
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
- HighAVID Medical Recalls Halyard Kits Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- ModerateAvid Medical Recalls Obstetrical Packs With Foreign Material in Needles
FDA (Devices) · 2018-03-07
- ModerateHalyard SUTURE PACK CABG Cardiovascular Kit Needle Coating Issue
FDA (Devices) · 2025-05-21
- HighAVID Medical Recalls Halyard Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- ModerateHalyard CHRIST SUTURE KIT surgical needles coating defect recall
FDA (Devices) · 2025-05-21
- ModerateAvid Medical Recalls Shoulder Arthroscopy Kits with Foreign Material
FDA (Devices) · 2018-03-07