MediChoice¿ Rayon Tipped OB/GYN Applicator — Class II medical device recall Z-1192-2013
Terminated recall by Owens & Minor Distribution, Inc., reported 2013-05-08, distributed nationwide. Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch prod
| Recall number | Z-1192-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Owens & Minor Distribution, Inc., Mechanicsville, VA, United States |
| Recall initiated | 2013-03-26 |
| Classified | 2013-04-30 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2014-10-31 |
| Distributed | Nationwide (US) |
| Quantity | 4,298.5 cases |
| Lot numbers | 1206DG13A, 1206DG13B, 1206DG14A, 1207DG13A, 1208DG13A, 1208DG14A, 1209DG13A, 1209DG14A, 1210DG13A/B, 1211DG13A, 1211DG14A, 1212DG13A, 1301DG13A, 1303DG13A, 2017-05, 2017-06, 2017-07, 2017-08, 2017-09, 2017-10, 2017-11, 2018-02, WOD5001, WOD5002 |
| Model numbers | 1206DG13A, 1206DG13B, 1206DG14A, 1207DG13A, 1208DG13A, 1208DG14A, 1209DG13A, 1209DG14A, 1210DG13A/B, 1211DG13A, 1211DG14A, 1212DG13A, 1301DG13A, 1303DG13A, 2017-05, 2017-06, 2017-07, 2017-08, 2017-09, 2017-10, 2017-11, 2018-02, WOD5001, WOD5002 |
Product
MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.
Reason for recall
Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use.
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-1192-2013. 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.