STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST — Class II medical device recall Z-2161-2019
Terminated recall by Centurion Medical Products Corporation, reported 2019-08-14, distributed nationwide. Potential for sterile packaging to be compromised
| Recall number | Z-2161-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Centurion Medical Products Corporation, Williamston, MI, United States |
| Recall initiated | 2019-07-01 |
| Classified | 2019-08-06 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-06-26 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| Lot numbers | 2019030490, 2019041790 |
| Expiration dates | 2024-02-29, 2024-03-31 |
Product
STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.
Reason for recall
Potential for sterile packaging to be compromised
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-2161-2019. 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.