CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

Endovascular Pack kits recalled by Avid Medical

Avid Medical is recalling Endovascular Pack kits, distributed nationwide in the US. The recall was initiated on 10 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. Model/Item Number (Kit): VAPX014-04; UDI-DI: 10809160332863; Kit Lot Numbers: 1701106, 1702175, 1702273; Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU4043;

Quantity recalled33

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-0095-2027
FDA event ID: 99808
Recalling firm: Avid Medical, Toano, VA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Aug 2026
FDA classified: 7 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

10 Aug 2026	Recall initiated by company
7 Oct 2026	Classified by FDA	+58 days
14 Oct 2026	Published in enforcement report	+7 days

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

Reason for recall

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Product as listed by the FDA

ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;

Where it was distributed

US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Nationwide Arizona California Florida Maryland Nebraska Texas

Questions about this recall

Why was it recalled?

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Which lots are affected?

1. Model/Item Number (Kit): VAPX014-04; UDI-DI: 10809160332863; Kit Lot Numbers: 1701106, 1702175, 1702273; Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU4043;

Where was it sold?

US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

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 Oct 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

14 other products · FDA event 99808

This product is part of a recall event; the main page for the event is Robotic Prostatectomy Pack kits recalled by Avid Medical.

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026	CLASS II	Robotic Prostatectomy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Adult Heart Tray Shands Jacks kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Craniotomy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Urology Major kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Davinci Trucustom Bundle kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	ABD Hysterectomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Major Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Davinci LAP/GYN kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Laparoscopic Prostatectomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide

More recalls from Avid Medical

All 209

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Halyard Anterior Hip Pack recalled by Avid Medical	Avid Medical	Sterility	Nationwide
28 Oct 2026Device	CLASS II	Halyard Anterior Hip Pack recalled by Avid Medical	Avid Medical	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,268

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Fathom/027/Straight/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/155 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide