Medline Arterial Catheter Recall Expanded; Full List of Affected Kits and Lots
The FDA's Class I recall of Medline integrated arterial catheters now covers a wider set of arterial line kits, bundles and trays, with no injuries or deaths reported on the record.
By AI ReporterFirst reported Feb 6, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 9:09 p.m. ET
The recall of integrated arterial catheters distributed by has been expanded to cover additional arterial line kits, bundles and trays, according to the FDA's medical device recall notice for recall number . The action was initiated on December 31, 2024.
The FDA says a manufacturing issue caused excess material to be present on the catheter hub, and that the material could detach, potentially entering the body at the insertion place or the bloodstream. The agency states that use of the affected product may cause serious adverse health consequences, including blockage of blood vessels (embolism) and death. The FDA record says there have been no reported injuries and no reports of death.
The recall is classified , which the FDA defines as its most serious category, used where there is a reasonable probability that using the product will cause serious harm or death.
The affected products are integrated arterial catheters found in arterial line insertion kits, bundles, trays or insertion trays. An arterial catheter is used to continuously monitor blood pressure and take blood samples from patients. The full current list of item numbers, as published by the FDA, is: ARTERIAL LINE INSERTION KIT, Item Number ART1185B/10653160379225; ARTERIAL LINE BUNDLE, ART255/10653160367598; ARTERIAL LINE TRAY, ART350/10653160362050; ARTERIAL LINE BUNDLE, ART355/10653160361817; ARTERIAL LINE INSERTION TRAY, ART475/10653160367659; ARTERIAL LINE BUNDLE - OR, ART535A/10653160367604; ARTERIAL LINE TRAY, ART545A/10653160375135; ARTERIAL LINE INSERTION KIT, ART775C/10653160366102; ARTERIAL LINE TRAY, ART840/10653160366966; ARTERIAL LINE KIT, ART890B/10653160360834; ARTERIAL LINE TRAY, ART600/10653160312727; and ARTERIAL LINE TRAY, ART690/10653160318019. The listed lots are: ART1185B: 2024102590; ART255: 2024082690, 2024101590; ART350: 2024093090; ART355: 2024081290, 2024112590; ART475: 2024100790, 2024073090, 2024081590, 2024090990; ART535A: 2024100890, 2024080190; ART545A: 2024102890; ART600: 2024101090; ART690: 2024092490; ART775C: 2024083090; ART840: 2024082390, 2024093090; ART890B: 2024100990.
The FDA tells customers not to use integrated arterial catheters from the affected item numbers and lots, to check stock immediately, to quarantine all affected product, and to remove the affected component before using the kit. Customers are directed to complete the response form at https://recalls.medline.com using Recall Reference #: . The FDA's enforcement database records no other enforcement action by this firm, a point that says nothing about fault in this action.
This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.
Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.
Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.
None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.