Recall Z-0886-2026 ยท OEZ Cardiovascular Procedure Kit
Medline Industries, LP
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
| Date | Dec 5, 2025 (initiated Oct 27, 2025) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Medline Industries issued an URGENT MEDICAL DEVICE RECALL to its consignee on 10/27/2025 via email. The notice explained the issue, potential risk, and requested the affected product be quarantined. Once the firm receives the response form, Medline will provide over-labels which are to be placed on kits that contain the recalled component and will state the affected component shall be removed and discarded from further use. Distributors and those further distributing the affected product are directed to notify those to whom the product was transferred or distributed of the recall. For q |
| Quantity | 15 units |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.