Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator — Class III medical device recall Z-1610-2015
Terminated recall by Zimmer Surgical Inc, reported 2015-05-20, distributed in AZ, CA, ID, IL, MD, NC, RI, SC. Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Pack
| Recall number | Z-1610-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Surgical Inc, Dover, OH, United States |
| Recall initiated | 2015-04-21 |
| Classified | 2015-05-13 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2015-11-06 |
| Distributed | AZ, CA, ID, IL, MD, NC, RI, SC |
| Countries outside the US | CA |
| Quantity | 36 units |
| Lot numbers | 62800843 |
| Model numbers | 00-2568-000-10 |
Product
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Reason for recall
Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.
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-1610-2015. 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.