STERILE STERILE PREP STICK — Class II medical device recall Z-0527-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-12-20, distributed nationwide. The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solu
| Recall number | Z-0527-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-11-03 |
| Classified | 2023-12-11 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 240 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10888277098022, 40888277098023 |
| Lot numbers | 2023082190 |
| Model numbers | DYNDA1134 |
Product
STERILE STERILE PREP STICK, REF DYNDA1134
Reason for recall
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
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-0527-2024. 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.