FDA Device recall Z-0733-2020
Lamicel 20PK 3MM INTL Cervical dilator
- FDA Device
- Class II
- ongoing
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of Lamicel 20PK 3MM INTL Cervical dilator by Medtronic Xomed, citing routine sterilization dose does not meet the required Sterility Assurance Level.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0733-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-11-13 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Xomed |
| Distribution | n/a |
Product
Lamicel 20PK 3MM INTL Cervical dilator
Reason
Routine sterilization dose does not meet the required Sterility Assurance Level.
Identifiers
| code_info | UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667…UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0733-2020%22
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