Excelsior Medical 10mL Sterile Field Saline Flush ZR — Class II medical device recall Z-0898-2022
Terminated recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2022-04-13, distributed nationwide. Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile
| Recall number | Z-0898-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-03-04 |
| Classified | 2022-04-08 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2023-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 7,800 pouched |
| Reason classes | sterility |
| Lot numbers | 3139133 |
| Model numbers | EMZ10091280 |
| Expiration dates | 2022-11-01 |
Product
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
Reason for recall
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
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-0898-2022. 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.