Getinge 88-Series Washer- Disinfector — Class II medical device recall Z-0016-2026
Ongoing recall by Getinge Disinfection Ab, reported 2025-10-08, distributed nationwide. Potential for device to overheat during operation if the circulation pressure calibration was not performed or
| Recall number | Z-0016-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Disinfection Ab, Vaxjo, N/A, Sweden |
| Recall initiated | 2025-08-29 |
| Classified | 2025-10-01 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CL, CN, CO, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, HK, HU, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LT, MX, NL, NO, NZ, PL, QA, RO, SA, SE, SG, TH, TR |
| Quantity | 902 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07340153700109, 07340153700116 |
| Model numbers | 88-5 |
Product
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Reason for recall
Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
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-0016-2026. 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.