3M Company - Health Care Business: Medical Device Recall in 2016 - (Recall #: Z-1563-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.

Product Classification:

Class II

Date Initiated: January 22, 2016

Date Posted: May 4, 2016

Recall Number: Z-1563-2016

Event ID: 73117

Reason for Recall:

3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.

Status: Terminated

Product Quantity: 74 valves

Code Information:

Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147

Distribution Pattern:

AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include: Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated