FDA DevicesClass II
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU ...
Published: June 24, 2026Recall ID: Z-2499-2026Category: devicesCountry: US
Reason for Recall / Hazard
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Product Description & Identification
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044
Affected Products
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98994 |
| Address 1 | 3 Lakes Dr |
| Code info | UDI/DI 10195327449476 (each), 40195327449477 (case), Lot Number 23HDA449 |
| Postal code | 60093-2753 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 730 units |
| Reason for recall | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260504 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260617 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.