Lamicel 20PK 3MM INTL Cervical dilator — Class II medical device recall Z-0733-2020
Ongoing recall by Medtronic Xomed, Inc., reported 2020-01-01. Routine sterilization dose does not meet the required Sterility Assurance Level.
| Recall number | Z-0733-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2019-11-13 |
| Classified | 2019-12-23 |
| Reported by FDA | 2020-01-01 |
| Countries outside the US | JP |
| Quantity | 29,320 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 20885074749024 |
| Lot numbers | 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693339, 9693346, 9693347, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438 |
Product
Lamicel 20PK 3MM INTL Cervical dilator
Reason for recall
Routine sterilization dose does not meet the required Sterility Assurance Level.
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-0733-2020. 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.