Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF… — Class II medical device recall Z-1546-2020
Terminated recall by Medline Industries Inc, reported 2020-04-01, distributed nationwide. Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Ty
| Recall number | Z-1546-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2020-02-10 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2023-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 3,690 units |
| Reason classes | sterility, packaging |
| Lot numbers | 18JBH655 |
| Model numbers | DYND3ML21G1A |
Product
Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
Reason for recall
Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
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-1546-2020. 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.