Recall of Medline Hysteroscopy Pack and Sling Pack

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Medline Industries is recalling 89 units of specific medical kits due to rescinded regulatory clearances for certain components.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 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 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 Article

What Happened

The recall is due to the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing having been rescinded.

Which Products Are Affected

The affected products are: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B. A total of 89 units are involved, with distribution across the United States. Specific codes include: 1) DYNJ48399C, UDI-DI: 10195327172626 (each), 40195327172627 (case), Lot Number: 24CBU779; 2) DYNJ62849B, UDI-DI: 10195327514884 (each), 40195327514885 (case), Lot Number: 24BBS275. The official recall number is Z-1847-2026.

What You Should Do

Consumers who have these products should contact the recalling firm, Medline Industries, LP, as the recall was initiated via letter for further instructions.

Why This Matters

This recall involves medical devices that may not comply with regulatory standards, potentially affecting their safe use in healthcare settings.

Source

FDA Recall Notice: Z-1847-2026

Original source: FDA Official Notice ↗

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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 is recalling 89 units of specific medical 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.