Stryker Medela REF 077 — Class II medical device recall Z-1502-2021
Terminated recall by Medela AG Medical Technology, reported 2021-05-05, distributed nationwide. Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-
| Recall number | Z-1502-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medela AG Medical Technology, Baai, N/A, Switzerland |
| Recall initiated | 2020-12-02 |
| Classified | 2021-04-27 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2024-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Quantity | 6,244 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 07612367052719, 07612367053921 |
| Lot numbers | W-024423 |
| Model numbers | 077.0193, 077.0193AXS |
Product
Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.
Reason for recall
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
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-1502-2021. 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.