Getinge AGS — Class II medical device recall Z-1380-2018
Terminated recall by Getinge Disinfection Ab, reported 2018-04-25, distributed nationwide. There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected g
| Recall number | Z-1380-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Disinfection Ab, Vaxjo, Sweden |
| Recall initiated | 2018-03-02 |
| Classified | 2018-04-16 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2022-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CN, CO, CZ, DE, DK, ES, FI, FR, GB, HK, IT, JP, KR, KW, MY, NL, NO, SA, SE, SG, SI, TH |
| Quantity | 170 products |
| UPC / GTIN / UDI-DI | 07340153700109, 07340153700116 |
| Serial numbers | WAA056686, WAA057547, WAA058540, WAA058542, WAA058543, WAA058545, WAA058549, WAA058550, WAA058551, WAA058552, WAA058553, WAA058554, WAA059053, WAA059054, WAA059058, WAA059059, WAA059509, WAA059510, WAA059630, WAA059785, WAA060117, WAA060690, WAA060871, WAA060886, WAA060887 and 135 more |
Product
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
Reason for recall
There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.
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-1380-2018. 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.