FDA Recalls Medline Syringes Due to Regulatory Issues

Source: FDA · United States

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Medline Industries is recalling 38,230 units of various syringes after their regulatory clearances were rescinded, affecting products distributed nationwide in the US.

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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Medline Industries, LP is recalling certain control syringes, guidewires, and high-pressure tubing because the 510(k) regulatory clearances for these products have been rescinded.

Which Products Are Affected

The affected products include: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR. Specific UDI-DI codes and lot numbers are provided, such as UDI-DI: 10884389676486 for DYNJSYR12CWR with lot numbers like 25ABF227. A total of 38,230 units are affected, distributed nationwide in the United States. The recall number is Z-1831-2026.

What You Should Do

Consumers should follow the initial firm notification, which was a letter, and contact Medline Industries, LP for instructions on returns or refunds. For more details, reach out to the firm at their address: 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

This recall involves medical devices that may pose risks due to regulatory issues, potentially affecting patient safety in healthcare settings.

Source

Source: FDA, Recall Number Z-1831-2026. For more information, visit the FDA website at https://www.fda.gov/medical-devices/medical-device-recalls/.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries is recalling 38,230 units of various syringes after their regulatory clearances were rescinded, affecting products distributed nationwide in the US.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.