Servo-i Ventilator — Class II medical device recall Z-0092-2021
Ongoing recall by Getinge Group Logistics America, LLC, reported 2020-10-21, distributed in AZ, CA, GA, IL, MN, MO, NC, NJ…. A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Ne
| Recall number | Z-0092-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Group Logistics America, LLC, Wayne, NJ, United States |
| Recall initiated | 2020-09-17 |
| Classified | 2020-10-09 |
| Reported by FDA | 2020-10-21 |
| Distributed | AZ, CA, GA, IL, MN, MO, NC, NJ, NY, RI, SC, TX, VA, WI, WV |
| Countries outside the US | AE, CZ, DE, FR, ID, IN, IQ, IT, KE, KR, LB, LK, NO, PE, QA, SA, SE, SK, TH, UA |
| Quantity | 431 units |
| UPC / GTIN / UDI-DI | 07325710000823 |
| Lot numbers | 6487800 |
| Serial numbers | 95160, 95283, 95284, 95285, 95286, 95287, 95288, 95289, 95290, 95291, 95292, 95293, 95294, 95295, 95296, 95297, 95363, 95364, 95365, 95366, 95367, 95368, 95369, 95370, 95371 and 405 more |
| Model numbers | 6487800 |
Product
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
Reason for recall
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
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-0092-2021. 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.