Amsco V-PRO 1 PlusRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K083097, K102330, K102394, K111810, K112813, K120632, K131120, K160433, K162413, K172319, K190103); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jul 26, 2018Terminated

   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.

   Z-2959-2018 · Root cause: Software design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083097, K102330, K102394, K111810, K112813, K120632, K131120, K160433, K162413, K172319, K190103. One submission often covers many models, so check the product and lot details in each record.

• Z-0772-2018 · Sep 28, 2017 · Terminated
  V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
• Z-3041-2011 · Aug 1, 2011 · Terminated
  Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. The STERIS Amsco V-PRO and V-PRO 1 Plus Low Temperature Ste