FDA Device recall Z-2959-2018

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 S…

FDA Device
Class II
terminated
Published 2018-09-12

On 2018-09-12 the FDA classified a Class II recall of 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 S… by Steris, citing 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 steril….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2959-2018
Classification	Class II
Status	terminated
Initiated	2018-07-26
Published	2018-09-12
Last updated	2026-09-13 11:54 UTC
Company	Steris
Distribution	US

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

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.

Identifiers

code_info	UDI numbers 00724995151973, 00724995151980, 00724995151997, and 00724995152000, 00724995151997, 00724995154677, 0072499… UDI numbers 00724995151973, 00724995151980, 00724995151997, and 00724995152000, 00724995151997, 00724995154677, 00724995154684, and 00724995154691. Serial numbers: 012320701 012320702 033260705 033250701 033260706 030630806 030730804 030770803 030800806 030890801 030910801 030850807 031170801 031540802 031570820 031030803 031690801 031700816 031710847 031500830 031720801 031860805 031540803 031220802 032000818 031650808 031820810 032110802 032240802 032250808 032260801 032290826 032330801 032320808 032270808 032290805 032290825 032330802 032350801 032210820 032380801 032380802 032460801 032460809 032520802 031500819 031850801 032520804 032200804 032460810 032560801 032680807 031770802 032670807 032710803 031500838 032330808 032200805 032560802 032700806 032560804 032750827 032560803 031030802 032750831 032740804 032750832 032820802 032820804 032820803 032820808 032820809 032970828 032820807 032940807 031800

code_info

UDI numbers 00724995151973, 00724995151980, 00724995151997, and 00724995152000, 00724995151997, 00724995154677, 0072499…

UDI numbers 00724995151973, 00724995151980, 00724995151997, and 00724995152000, 00724995151997, 00724995154677, 00724995154684, and 00724995154691. Serial numbers: 012320701 012320702 033260705 033250701 033260706 030630806 030730804 030770803 030800806 030890801 030910801 030850807 031170801 031540802 031570820 031030803 031690801 031700816 031710847 031500830 031720801 031860805 031540803 031220802 032000818 031650808 031820810 032110802 032240802 032250808 032260801 032290826 032330801 032320808 032270808 032290805 032290825 032330802 032350801 032210820 032380801 032380802 032460801 032460809 032520802 031500819 031850801 032520804 032200804 032460810 032560801 032680807 031770802 032670807 032710803 031500838 032330808 032200805 032560802 032700806 032560804 032750827 032560803 031030802 032750831 032740804 032750832 032820802 032820804 032820803 032820808 032820809 032970828 032820807 032940807 031800

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2959-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.