Recall of Medline Hysteroscopy Pack and Sling Pack
Medline Industries is recalling 89 units of specific medical kits due to rescinded regulatory clearances for certain components.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 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.
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.
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to the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing having been rescinded.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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Common questions about this FDA recall.