Sharp Medical Products: Medical Device Recall in 2021 - (Recall #: Z-1366-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 8, 2021

Date Posted: April 14, 2021

Recall Number: Z-1366-2021

Event ID: 87432

Reason for Recall:

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

Status: Terminated

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

Code Information:

Catalogue Number: 100-36-01 Lot Number: 0818-009

Distribution Pattern:

U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None

Voluntary or Mandated:

Voluntary: Firm initiated