Invia Motion Negative Pressure Wound Therapy System — Class II medical device recall Z-2528-2018
Terminated recall by Medela Inc, reported 2018-08-01, distributed nationwide. Device may display a battery missing error.
| Recall number | Z-2528-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medela Inc, McHenry, IL, United States |
| Recall initiated | 2018-02-07 |
| Classified | 2018-07-23 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2018-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DK, ES, IT, NL, SE |
| Quantity | 778 units |
| Serial numbers | 002, 014, 085, 096, 098, 112, 116, 121, 124, 160884, 1660883, 1660886, 1660887, 1660888, 1660894, 1660895, 1660901, 1660904, 1660907, 1660908, 1660915, 1660916, 1660918, 1660920, 1660921 and 264 more |
| Model numbers | 087.4010, 087.4012, 087.4014, 087.4020, 087.4022, 087.4024 |
Product
Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negative Pressure Wound Therapy (Model 087.4024). Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
Reason for recall
Device may display a battery missing error.
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-2528-2018. 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.