Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A… — Class II medical device recall Z-1858-2019
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2019-07-03, distributed nationwide. Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk o
| Recall number | Z-1858-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2019-05-28 |
| Classified | 2019-06-21 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2023-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GH, HK, HR, HU, IE, IL, IN, IQ, IR, IT, JO, JP, KR, LB, LU, LV, MX, MY, NG, NL, NO, NZ, OM, PA, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SK, TH, TR, TT, TW, VE, VN, ZA |
| Quantity | 6 units |
| Reason classes | packaging |
| Serial numbers | 500002, 500003, 500004, 500005, 500007, 500008 |
| Model numbers | VST60DFAIM |
Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
Reason for recall
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
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-1858-2019. 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.