Sterile EXACTAMED Oral Dispenser — Class II medical device recall Z-0806-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-03-07, distributed in IL, MA, MD, OH, SD, TX, VA, WI. Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect
| Recall number | Z-0806-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-02-06 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2021-04-02 |
| Distributed | IL, MA, MD, OH, SD, TX, VA, WI |
| Countries outside the US | CA |
| Quantity | 2,800 units |
| Reason classes | labeling |
| Lot numbers | 1203395 |
| Expiration dates | 2019-11-30 |
Product
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Reason for recall
Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
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-0806-2018. 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.