CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report

Halyard Endovascular - Medical convenience kits recalled by AVID Medical

AVID Medical is recalling Halyard Endovascular - Medical convenience kits, distributed nationwide in the US. The recall was initiated on 20 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 10809160334935 Lot Number: 1583502, 1605477
Quantity recalled24 eaches

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0449-2025
FDA event ID
95515
Recalling firm
AVID Medical, Toano, VA
Classification
Class II
Status
Ongoing
Recall initiated
20 Sep 2024
FDA classified
14 Nov 2024
Reported
20 Nov 2024
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Foreign Material

Timeline

20 Sep 2024Recall initiated by company
14 Nov 2024Classified by FDA+55 days
20 Nov 2024Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Which lots are affected?

GTIN: 10809160334935 Lot Number: 1583502, 1605477

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

72 other products · FDA event 95515

This product is part of a recall event; the main page for the event is Halyard KIT, Shoulder - Medical convenience kits recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIHalyard KIT, Shoulder - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Pacemaker Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Kit, Cardiac Robotic - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard D & C Pack-ckc - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Kit, Total Knee - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Pacemaker PK - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Kit, Total Knee - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Cpt Peds Adult CH Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard OR Endovascular Tray - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Open Heart Pack Main - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Manifold Cath Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Upper Extremity Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Cysto PDS - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Total Knee - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard RAD PACK - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard IR Abcess Drainage Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Cpt Cardiac Cath Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Vag Hysterectomy Bundle PK - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Ivr Vascular Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard IR Biopsy Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Interventional Tray - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard EYE - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Post Partum Tubal Ligation - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Shoulder Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Anterior Hip Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Angiography Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Pacemaker Drape - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Oral Surgery Head - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Angio Pack - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Tah-bundle - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Angio Arteriogram Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Kit, Total Knee - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Lower Extremity Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Basic Procedure Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Pack, Minor - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Extremity Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Pacemaker Tray - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Sammc Angiography - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Knee Arthroscopy Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Aorta Pack - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard ENT T AND A PACK - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard VA Lumbar Laminectomy - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Angio Tray - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Biopsy Pack - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard KIT, Spine - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard GYN TRAY - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard C Section Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard ENT - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard CPT EP PACK - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Major Vaginal Gyn Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Foot Ankle Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Laparotomy Gyn Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Ortho Pack -Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard KIT, Spine - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Angiography Drape Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Urology Laparotomy Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Abdominal Procedure - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Cath Lab Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Minor Pack - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard General Set UP Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Pacemaker Instrument Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard EP TRAY - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Specials Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Cpt Peds Adult CH Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Line Insertion Pack - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Minor PDS - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Sammc-n Pacemaker - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard C Section Bundle - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Heart Cath Lab PK, Strl F G - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard GYN PAC - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide
CLASS IIHalyard Laparoscopy Tray - Medical convenience kits recalledAVID MedicalForeign MaterialNationwide
CLASS IIHalyard EP PACK - Medical convenience kits recalled by AVID MedicalAVID MedicalForeign MaterialNationwide

More recalls from AVID Medical

All 184
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIHalyard IV Start Kit Non-Sterile recalled by Avid MedicalAvid MedicalSterilityNationwide
DeviceCLASS IINeuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalledAVID MedicalSterilityNationwide
DeviceCLASS IIHalyard medical convenience kits labeled as: ENT recalledAVID MedicalSterilityNationwide
DeviceCLASS IIHalyard medical convenience kits labeled as: A-P PACK recalledAVID MedicalSterilityNationwide
DeviceCLASS IIHalyard Total Joint recalled by AVID MedicalAVID MedicalForeign MaterialNationwide

Other Heart & Vascular Devices recalls

All 6,199
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIGetinge PVC Thoracic Catheter, Soft PVC Right Angle recalledAtrium MedicalPotency & AssayNationwide
DeviceCLASS IIProducts that contain the Pericare Wipes: *Bardex¿ I.C recalledC.R. BardOtherNationwide
DeviceCLASS IIProducts that contain the Pericare Wipes recalled by C.R. BardC.R. BardOtherNationwide
DeviceCLASS IIProducts that contain the Pericare Wipes recalled by C.R. BardC.R. BardOtherNationwide
DeviceCLASS IIGetinge PVC Thoracic Catheter, Firm PVC Straight recalledAtrium MedicalPotency & AssayNationwide