Recall of Medline Convenience Kits Due to Unapproved Design Changes
Medline Industries, LP is recalling certain convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes, affecting 270,311 units distributed nationwide and internationally.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 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 due to unapproved design changes to the products outside of the 510(k) clearance.
Which Products Are Affected
The affected products are Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes, including the following: BASIC CL PACK-LF (DYNJ87052), BASIC PACK (DYNJ83976), BASIC SET UP PACK (DYNJ80700), CORONARY ANGIOGRAPHY PACK (N) (DYNJ42136B), CSTM ANGIO KIT - S VASC1109 (VASC1109), CV PACK (DYNJ46301C), DR F PACK (DYNJ41253B), ENSEMBLE HEMORROIDES (DYNJ56311A), G TAVR PACK (DYNJ61006), IR MINOR PACK (DYNJ44139C), MAJOR PLUS PACK (DYNJ905160N), MAXIMUM BARRIER BUNDLE PACK (DYNJ35216C), PCI PACK TBRHSC-LF (DYNJ41941D), PERC PACK-LF (DYNJ0774759P), PERIPHERAL ANGIOGRAPHY PK (DYNJ42094B), PROCEDURE PACK (DYNJ55063B), PTCA PACK (DYNJ55359B), ROBOTIC PACK (DYNJ908706C), SPECIAL PROCEDURES TRAY (DYNJ41174A), SYRINGE WIRE KIT SANFORD (SAMPC0644), WPH EP PACK (DYNJ62745), and X-RAY PACK (DYNJ44295G). The total quantity affected is 270,311 units. Specific lots and UDI-DI codes are provided in the source data, with distribution in the United States nationwide and countries including Canada, Panama, and Barbados.
What You Should Do
Consumers should follow the firm's initial notification via letter and contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753, for information on returns or refunds related to this recall.
Why This Matters
This recall involves medical devices with unapproved changes, which could potentially affect product safety and efficacy, impacting healthcare providers and patients relying on these kits for procedures.
Source
Attribution: FDA Recall Number Z-1883-2026. For more information, refer to the FDA's official recall database.
Original source: FDA Official Notice ↗
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