Data Foundry

Medical device recalls 2025

Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT — Class I medical device recall Z-0991-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-02-05, distributed nationwide. The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the cath

Recall numberZ-0991-2025
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated2024-12-31
Classified2025-01-29
Reported by FDA2025-02-05
DistributedNationwide (US)
Quantity942 kits
UPC / GTIN / UDI-DI00653160360837, 00653160361810, 00653160362053, 00653160366105, 00653160366969, 00653160367591, 00653160367607, 00653160367652, 00653160375138, 00653160379228, 10653160360834, 10653160361817, 10653160362050, 10653160366102, 10653160366966, 10653160367598, 10653160367604, 10653160367659, 10653160375135, 10653160379225
Lot numbers2024073090, 2024080190, 2024081290, 2024081590, 2024082390, 2024082690, 2024083090, 2024090990, 2024093090, 2024100790, 2024100890, 2024100990, 2024101590, 2024102590, 2024102890, 2024112590
Model numbersART1185B, ART255, ART350, ART355, ART475, ART535A, ART545A, ART775C, ART840, ART890B

Product

Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6) ARTERIAL LINE INSERTION TRAY, Item Number ART475; 7) ARTERIAL LINE BUNDLE - OR, Item Number ART535A; 8) ARTERIAL LINE TRAY, Item Number ART545A; 9) ARTERIAL LINE INSERTION KIT, Item Number ART775C; 10) ARTERIAL LINE TRAY, Item Number ART840; 11) ARTERIAL LINE KIT, Item Number ART890B

Reason for recall

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

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-0991-2025. 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.