MEDLINE Kits — Class I medical device recall Z-1103-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-03-06, distributed nationwide. Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse
| Recall number | Z-1103-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2024-02-24 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, PA |
| Quantity | 5,969 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10195327162733, 10195327279950, 10195327449223, 10889942384006, 40195327162734, 40195327279951, 40195327449224, 40889942384007 |
| Lot numbers | 22FBC677, 22FBU123, 22FBV837, 22HBA432, 22HBL534, 22IMH103, 22JBG195, 22KMA408, 22LMG525, 23ABD211, 23ABD269, 23ABE326, 23ABF156, 23BBE110, 23CBG139, 23CBU443, 23CBX144, 23CBX181, 23CBX187, 23FBN050, 23FBO144, 23FBO502, 23FBR603, 23HBO128 |
| Model numbers | CDS983912Y, DYKE1364B, DYKE1387, DYKE1648I, DYKE1892, DYKE1930A, DYKM2222, DYNJ904653G, M101426, UT13535 |
Product
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS, REF CDS983912Y; i) PLASTICS SUTURE TRAY, REF SUT13535; j) SNES ENDO KIT, REF DYKE1930A
Reason for recall
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being 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-1103-2024. 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.