EXACTAMED Oral Dispensers — Class III medical device recall Z-0050-2020
Terminated recall by Baxter Healthcare Corporation, reported 2019-10-16, distributed nationwide. Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
| Recall number | Z-0050-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2019-08-13 |
| Classified | 2019-10-07 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2020-11-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,719,200 dispenser |
| Lot numbers | B301N017P, B301N023P, B301N049P, B301N056P, B301N070P, B302N077P, B303N042P, B303N108P, B304N045P, B307N015P |
| Model numbers | 100, 1500, 500, H9388105, H93884205, H9388505 |
Product
EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent administration of liquid medication and nutrition to humans through the patient s mouth.
Reason for recall
Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
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-0050-2020. 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.