Aesculap Implant Systems LLC: Medical Device Recall in 2022 - (Recall #: Z-1449-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.

Product Classification:

Class II

Date Initiated: October 1, 2019

Date Posted: July 27, 2022

Recall Number: Z-1449-2022

Event ID: 90475

Reason for Recall:

Packaging seal integrity not validated resulting in a lack of sterility assurance.

Status: Terminated

Product Quantity: 4500 pieces

Code Information:

UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.

Distribution Pattern:

United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI

Voluntary or Mandated:

Voluntary: Firm initiated