Medline Convenience Kits Recall for Unapproved Design Changes
Medline Industries is recalling 270,311 units of 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 containing select SKUs of 10mL polycarbonate colored syringes because of unapproved design changes to the products that were made outside of the 510(k) clearance.
Which Products Are Affected
The affected products include the following Medline Convenience Kits: EXTREMITY PACK (DYNJ34846C), HAND PACK (DYNJ83218A and DYNJ85396), LAMINECTOMY (DYNJ905156R), MAJOR EXTREMITY (DYNJ905159L and DYNJ905159M), MAJOR EXTREMITY PACK (DYNJ69926A), and PODIATRY PACK (DYNJ41250B). A total of 270,311 units are affected. Specific codes include: DYNJ34846C with UDI-DI 10193489781441 (EA) and 40193489781442 (CS), Lot 24BBA459; DYNJ83218A with UDI-DI 10195327382308 (EA) and 40195327382309 (CS), Lot 24BBD199; DYNJ85396 with UDI-DI 10195327497613 (EA) and 40195327497614 (CS), Lot 24BBA503; DYNJ905156R with UDI-DI 10198459017704 (EA) and 40198459017705 (CS), Lots 24HBG726, 24JBJ484, 25ABS758, 25BBR196, 25CBN174, 25EBE136; DYNJ905159L with UDI-DI 10195327664251 (EA) and 40195327664252 (CS), Lot 24EMB726; DYNJ905159M with UDI-DI 10198459017735 (EA) and 40198459017736 (CS), Lots 24GMA714, 24HMD401, 24HMJ945, 24JMD201, 24KMG592, 25AMC024, 25BMD945, 25CMG373; DYNJ69926A with UDI-DI 10195327153601 (EA) and 40195327153602 (CS), Lot 24ABS445; DYNJ41250B with UDI-DI 10888277801257 (EA) and 40888277801258 (CS), Lot 24ABO122. The products were distributed US nationwide and to Canada, Panama, and Barbados.
What You Should Do
Consumers who have these products should follow the initial firm notification, which was issued via letter, and contact Medline Industries, LP for instructions on returns or refunds. For more information, reach out to the recalling firm at their address: 3 Lakes Dr, Northfield, IL 60093-2753.
Why This Matters
This recall involves medical devices with unapproved changes, classified as Class II by the FDA, indicating a potential for temporary or reversible health consequences. It highlights the importance of regulatory compliance in device manufacturing to ensure patient safety.
Source
Attribution: FDA Recall Number Z-1887-2026. For full details, visit the FDA website at https://www.fda.gov/medical-devices/medical-device-recalls.
Original source: FDA Official Notice ↗
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