Recall of Medline GENERAL LAPAROSCOPY Kits

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Medline Industries, LP is recalling 75 units of GENERAL LAPAROSCOPY kits due to rescinded regulatory clearances for certain components.

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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

Recall of Medline GENERAL LAPAROSCOPY Kits

What Happened

Medline Industries, LP initiated a voluntary recall because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Which Products Are Affected

The affected product is Medline Kits: GENERAL LAPAROSCOPY, Model Number: CDS930027Y. The recall involves 75 units with UDI-DI: 10198459303128 (each) and 40198459303129 (case), and Lot Number: 25EBE671. This recall is for products distributed nationwide in the United States.

What You Should Do

Consumers should contact Medline Industries, LP as per the initial firm notification via letter for further instructions on the recall.

Why This Matters

This recall affects medical devices and could impact patient safety due to the rescinded clearances, highlighting the importance of regulatory compliance in healthcare products.

Source

FDA Recall Number: Z-1840-2026, attributed to FDA based on event ID 98599.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling 75 units of GENERAL LAPAROSCOPY kits due to rescinded regulatory clearances for certain components.
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.