Breg Inc: Medical Device Recall in 2017 - (Recall #: Z-1906-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.

Product Classification:

Class II

Date Initiated: March 30, 2017

Date Posted: May 10, 2017

Recall Number: Z-1906-2017

Event ID: 76994

Reason for Recall:

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

Status: Terminated

Product Quantity: 2,609 units total

Code Information:

D163544

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated