FDA Device recall Z-0886-2026
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
- FDA Device
- Class II
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class II recall of MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C by Medline Industries, citing medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirm….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0886-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-27 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Reason
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.
Identifiers
| code_info | UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0886-2026%22
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