McKesson Medi-Pak Vaginal Speculum — Class II medical device recall Z-1824-2015
Terminated recall by CooperSurgical, Inc., reported 2015-07-01, distributed nationwide. Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
| Recall number | Z-1824-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2015-04-13 |
| Classified | 2015-06-22 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2016-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 9,400 units |
Product
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
Reason for recall
Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
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-1824-2015. 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.