RecallReported September 9, 2026

Class II recall by Medline Industries, LP

Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C

FDA's record ↗

FDA's enforcement report of September 9, 2026 lists a Class II recall by Medline Industries, LP of Northfield, IL. Product: Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C. Status: Ongoing.

On the record

Recalling firm
Medline Industries, LP
Location
Northfield, IL
Classification
Class II
Status
Ongoing
Recall number
Z-3053-2026
Product type
Devices
Recall initiated
2026-06-12
Reported by FDA
2026-09-09
Source
FDA enforcement reports ↗

The full record

An account shows the reason for the recall, where the product was distributed and the lots.

What a recall is

FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.

More

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From FDA enforcement reports. The record may have changed since it was read.

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