Advanced Sterilization Products: Medical Device Recall in 2013 - (Recall #: Z-0402-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Product Classification:

Class II

Date Initiated: November 11, 2013

Date Posted: December 4, 2013

Recall Number: Z-0402-2014

Event ID: 66815

Reason for Recall:

Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.

Status: Terminated

Product Quantity: Total 4,381 units

Code Information:

Please refer to consignee list

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated