FDA Announces Recall of Medline Convenience Kits with Syringes
Medline Industries is recalling over 270,000 units of certain convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes outside of 510(k) clearance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Medline Industries, LP is recalling certain convenience kits because of unapproved design changes to the products that were made outside of the required 510(k) clearance.
Which Products Are Affected
The recall involves Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes. Affected products include: TAVR PACK (DYNJ69246B), ABDOMINAL VASCULAR-LF (DYNJ905291D), ANGIOGRAPHIC PACK (DYNJ86769), AORTAGRAM PACK (DYNJ26783D), AV FISTULA PACK CHS-LF (DYNJ35615G), AV SHUNT PACK-LF (DYNJ0842516G), CATHETER PACK (DYNJ61926), EP DRAPE PACK-LF (DYNJ47645C), EP PACK (DYNJ47782G), EPS ACCESSORY PACK (DYNJT2201S), H CLINIC VASCULAR PK (DYNJ33415A), HEART FAILURE PACK (DYNJ64877B), HYBRID PACK (DYNJ65925D), INTERVENTIONAL RAD PACK (DYNJ44100M), INTERVENTIONAL RADIOLOGY PK-LF (DYNJ0516014AG), MV-PACEMAKER PACK-LF (DYNJ41556F), NEURO RADIOLOGY RICHMOND (DYNJ68365D), OR HYBRID-M (DYNJ907758D, DYNJ907758F), PACEMAKER (DYNJ907960C), PACEMAKER PACK (DYNJ42557B, DYNJ61411, DYNJ61411A, DYNJ61411B, DYNJ80160), PACER PACK (DYNJ40952B), PERIPHERAL ARTERIOGRAM RAD (DYNJ61383B), RADIOLOGY PACK (DYNJ54762D), TAVR PACK (DYNJ55338B, DYNJ69246A), VASCULAR ACCESS TRAY (DYNJ52606F), VASCULAR TRAY (DYNJ49802C), and VEIN PACK (DYNJ57512, DYNJ58063, DYNJ84953). The total quantity affected is 270,311 units. Specific lots and UDI-DIs are listed in the recall details. Distribution was nationwide in the US and to Canada, Panama, and Barbados.
What You Should Do
Consumers who have the affected products should refer to the initial firm notification letter from Medline Industries for further instructions, as the recall was initiated voluntarily by the firm.
Why This Matters
This recall affects over 270,000 medical devices distributed worldwide, underscoring the need for compliance with regulatory approvals to ensure product safety and efficacy.
Source
FDA recall notice: Z-1878-2026
Original source: FDA Official Notice ↗
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