AMSCO V-PRO 1 — Class II medical device recall Z-2959-2018
Terminated recall by Steris Corporation, reported 2018-09-12, distributed nationwide. There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered d
| Recall number | Z-2959-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2018-07-26 |
| Classified | 2018-08-31 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2020-03-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, KY, LB, LT, MA, MT, MX, MY, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, SA, SG, TH, TN, TR, TW, UY, VE, VN, ZA |
| Quantity | 2,889 units |
| UPC / GTIN / UDI-DI | 00724995151973, 00724995151980, 00724995151997, 00724995152000, 00724995154677, 00724995154684, 00724995154691 |
| Serial numbers | 012320701, 012320702, 030021203, 030021204, 030021316, 030021318, 030021411, 030021412, 030021413, 030021706, 030021714, 030031114, 030031208, 030031209, 030031309, 030031310, 030031412, 030031413, 030031414, 030031826, 030031829, 030031830, 030031831, 030041102, 030041202 and 475 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2959-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.