Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description Recalled by Bard Medical Division Due to Specific lots of ArcticGel Pads have potential issues...

Date: November 8, 2017
Company: Bard Medical Division
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bard Medical Division directly.

Affected Products

Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

Quantity: 7526 units

Why Was This Recalled?

Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bard Medical Division

Bard Medical Division has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report