# FDA recall Z-2959-2018

> **Steris Corporation** · Class II · device recall initiated 2018-07-26.

## Product

AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems     The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices in Healthcare Facilities.

## Reason for recall

There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.

## Distribution

Worldwide Distribution: US(nationwide) and to countries of:  Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Belarus, Brazil,  Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of),  Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Nepal, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Suriname, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom,  Uruguay, Uzbekistan, Venezuela, and Vietnam.

## Key facts

- **Recall number:** Z-2959-2018
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-26
- **Report date:** 2018-09-12
- **Termination date:** 2020-03-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mentor, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2959-2018

## Citation

> AI Analytics. FDA recall Z-2959-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2959-2018. Source: US FDA. Licensed CC0.

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