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.
4 reports on this incident · first at Aug 7, 2026, 8:55 p.m. ET
Earlier reports
Aug 7, 2026, 9:05 p.m. ET
FDA Lists Medline Arterial Catheter Recall at Class I, Its Most Serious Category
The FDA's medical device recall record for Medline Industries, LP's Integrated Arterial Catheters carries a hazard classification of Class I, recall number R-24-278-FGX1. The FDA defines Class I as its most serious category, used where there is a reasonable probability that using the product will cause serious harm or death. The record as supplied does not state which classification applied previously, so the earlier designation has not been established here.
According to the FDA record, the action covers Integrated Arterial Catheters found in Medline arterial line insertion kits, bundles, trays and insertion trays, and was initiated on December 31, 2024. The agency states that 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's stated hazard is that use of 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 FDA's instructions to users are not to use the Integrated Arterial Catheters in affected item numbers and lots, to check stock immediately for those item numbers and lot numbers, to quarantine all affected product, to remove the affected component before using the kit, and to complete the response form at https://recalls.medline.com using Recall Reference #: R-24-278-FGX1. The affected item numbers listed are ART1185B (10653160379225), ART255 (10653160367598), ART350 (10653160362050), ART355 (10653160361817), ART475 (10653160367659), ART535A (10653160367604), ART545A (10653160375135), ART775C (10653160366102), ART840 (10653160366966), ART890B (10653160360834), ART600 (10653160312727) and ART690 (10653160318019), with lot numbers including 2024102590 for ART1185B; 2024082690 and 2024101590 for ART255; 2024093090 for ART350; 2024081290 and 2024112590 for ART355; 2024100790, 2024073090, 2024081590 and 2024090990 for ART475; 2024100890 and 2024080190 for ART535A; 2024102890 for ART545A; 2024101090 for ART600; 2024092490 for ART690; 2024083090 for ART775C; 2024082390 and 2024093090 for ART840; and 2024100990 for ART890B.
An arterial catheter, also called an arterial line, is a thin, flexible tube inserted through the skin into an artery — most often the radial artery at the wrist, or the femoral or brachial artery — so that arterial pressure can be measured directly and continuously and repeated arterial blood samples can be drawn, according to StatPearls on the NIH's NCBI Bookshelf and Wikipedia; those sources note the lines are generally not used to give medication. It is not a consumer product: it is a sterile, single-use device sold in kits and trays to hospitals and clinics and placed by trained clinicians in intensive care units, emergency departments and operating rooms. The FDA's enforcement database records no other enforcement action by this firm, which says nothing about fault in this action.
Aug 7, 2026, 8:59 p.m. ET
FDA Record on Recalled Medline Arterial Catheters Still Lists No Reported Injuries or Deaths
The FDA's recall record for Medline Industries, LP's integrated arterial catheters continues to state that "there have been no reported injuries" and "there have been no reports of death" associated with the affected product. The agency's notice, published on its medical device recalls pages, does not describe any adverse event linked to the defect.
The action, recall number R-24-278-FGX1, was initiated on December 31, 2024. According to the FDA, a manufacturing issue caused excess material to be present on the catheter hub, and that 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. It is classified Class I, 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 products are integrated arterial catheters found in Medline arterial line insertion kits, bundles, trays and insertion trays. An arterial catheter is used to continuously monitor blood pressure and take blood samples from patients. Under the U.S. regulatory definition cited in FDA guidance (21 CFR 880.5200), an intravascular catheter is a slender tube with any necessary connecting fittings, inserted into a patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids, and may be built of metal, rubber, plastic or a combination of these. It is a sterile, single-use prescription device distributed to hospitals, clinics and licensed practitioners rather than to the public, so those affected are healthcare facilities and the clinicians and patients within them.
The FDA tells users 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. Facilities are directed to complete the response form at https://recalls.medline.com using Recall Reference #: R-24-278-FGX1. Affected item numbers listed by the agency include ART1185B (lot 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) and ART890B (2024100990).
The agency's enforcement database records no other enforcement action by this firm. That says nothing about fault in this action.
Aug 7, 2026, 8:55 p.m. ETFirst report
Medline Recalls Integrated Arterial Catheters in Class I Action Over Excess Material on Catheter Hub
Medline Industries, LP is removing Integrated Arterial Catheters supplied inside arterial line insertion kits, bundles, trays and insertion trays, in an action the U.S. Food and Drug Administration has classified as Class I. The FDA's enforcement record, recall number R-24-278-FGX1, gives an initiation date of 31 December 2024. Class I is the FDA's most serious category, used where there is a reasonable probability that using the product will cause serious harm or death, according to the agency's own [recall definitions](https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions). The action is still developing.
According to the FDA notice, a manufacturing issue caused excess material to be present on the catheter hub, and that material could detach, potentially entering the body at the insertion place or the bloodstream. The agency states the hazard as serious adverse health consequences including blockage of blood vessels (embolism) and death. The FDA notice says there have been no reported injuries and no reports of death.
The FDA tells users not to use Integrated Arterial Catheters from the affected item numbers and lots, to check stock immediately, to quarantine all affected product, to remove the affected component before using the kit, and to complete the response form at https://recalls.medline.com using Recall Reference #: R-24-278-FGX1. The affected item numbers listed are ART1185B/10653160379225, ART255/10653160367598, ART350/10653160362050, ART355/10653160361817, ART475/10653160367659, ART535A/10653160367604, ART545A/10653160375135, ART775C/10653160366102, ART840/10653160366966, ART890B/10653160360834, ART600/10653160312727 and ART690/10653160318019. Lots listed 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 describes the product as an arterial catheter used to continuously monitor blood pressure and take blood samples from patients. Background reference material from the National Library of Medicine describes an arterial catheter as a thin, flexible plastic tube, typically single-lumen and a few centimetres long, made of a fluoropolymer such as PTFE or of polyurethane in gauges around 18–24, inserted through the skin into a peripheral artery — most often the radial artery at the wrist, sometimes the femoral or brachial artery — and connected to pressure tubing and a transducer. An "integrated" catheter is built as a single coaxial assembly combining the introducer needle and guidewire in one unit, supplied as one component inside a pre-packaged sterile kit or tray. These are not consumer products: they are single-use devices supplied to hospitals and clinics and placed by trained clinicians in intensive care units, operating rooms and emergency departments, so those affected are hospitals, procurement departments, clinical staff and the patients the kits are used on.
The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.
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