Class II — Potential Health Hazard

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

CARPAL TUNNEL PACK Recalled by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables Due to Covidien issued a labeling update for the Covidien...

Date: November 15, 2016
Company: Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
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 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables directly.

Affected Products

CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.

Quantity: US: 14 cases

Why Was This Recalled?

Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

Where Was This Sold?

This product was distributed to 3 states: FL, PA, VA

Affected (3 states)Not affected

About Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables has 10 total recalls tracked by RecallDetector.

Related Recalls

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