Advanced Sterilization Products: Medical Device Recall in 2013 - (Recall #: Z-1027-2013)

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 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.

Product Classification:

Class II

Date Initiated: March 22, 2013

Date Posted: April 10, 2013

Recall Number: Z-1027-2013

Event ID: 64692

Reason for Recall:

The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.

Status: Terminated

Product Quantity: 1038 units

Code Information:

Codes: 10217 10201-002 10201 10202-001

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated