Class II — Potential Health Hazard

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

SHARP MEDICAL PRODUCTS Recalled by Sharp Medical Products Due to Non-conformity (holes/punctures or deep creases) in the sterile...

Date: February 8, 2021
Company: Sharp Medical Products
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 Sharp Medical Products directly.

Affected Products

SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

Quantity: 129 units (63 units for Human-use and 66 units for Non-Human use)

Why Was This Recalled?

Non-conformity (holes/punctures or deep creases) in the sterile barrier.

Where Was This Sold?

This product was distributed to 6 states: AZ, FL, MI, OH, TX, WI

Affected (6 states)Not affected

About Sharp Medical Products

Sharp Medical Products has 1 total recall tracked by RecallDetector.

Related Recalls

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