AUTOCOMP6 XP High Speed Compounder REF 58810 — Class II medical device recall Z-2258-2016
Terminated recall by The Metrix Company, reported 2016-08-03, distributed in AL, AZ, CA, CO, CT, FL, IA, IL…. An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the design
| Recall number | Z-2258-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Metrix Company, Dubuque, IA, United States |
| Recall initiated | 2016-06-23 |
| Classified | 2016-07-22 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2023-04-11 |
| Distributed | AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, WA |
| Countries outside the US | AU, CA, DO, GB, MY, TR |
| Quantity | 93 devices |
| Model numbers | 58810 |
Product
AUTOCOMP6 XP High Speed Compounder REF 58810
Reason for recall
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
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-2258-2016. 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.