Versa — Class II medical device recall Z-2068-2019
Terminated recall by Epimed International, Inc., reported 2019-07-31, distributed in AR, CA, FL, ID, NY, OK, TX, WA. Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit c
| Recall number | Z-2068-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Epimed International, Inc., Johnstown, NY, United States |
| Recall initiated | 2019-06-18 |
| Classified | 2019-07-24 |
| Reported by FDA | 2019-07-31 |
| Distributed | AR, CA, FL, ID, NY, OK, TX, WA |
| Countries outside the US | MX, ZA |
| Quantity | 200 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10818788021394 |
| Lot numbers | 311291155, 31129155 |
| Model numbers | 181-2112 |
| Expiration dates | 2022-12-31 |
Product
Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia
Reason for recall
Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
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-2068-2019. 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.