Getinge 88-Series-washer disinfectors intended for cleaning — Class II medical device recall Z-1475-2020
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2020-03-18, distributed nationwide. Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the
| Recall number | Z-1475-2020 |
|---|---|
| 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 | 2020-02-10 |
| Classified | 2020-03-11 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2023-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CL, CN, CZ, DE, DK, EE, ES, FI, FR, GB, HK, IE, IL, IN, IQ, IR, IT, JP, KE, KR, LT, NL, NO, NZ, PL, QA, SA, SE, SG, SI, TH, TR |
| Quantity | 146 us |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07340153700109, 07340153700116 |
| Serial numbers | SEV0725124, SEV0745196, SEV0832057, SEV0832058, SEV0833080, SEV0833081, SEV0910147, SEV0912065, W50010582, W50010772, W50010773, W50010774, W50011211, W50011212, W50011809, W50011810, W50011811, W50012589, W50013228, W50013359, W50013362, W50013363, W50013983, W50013984, W50014009 and 124 more |
| Model numbers | 88-103, 88-203, 88-5 |
Product
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Reason for recall
Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
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-1475-2020. 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.