FDA Expands Medline Ultrasound Breast Pack Recall to Include Additional Lot
The FDA has expanded the recall of Medline Ultrasound Breast Packs to include an additional lot, citing potential microbial contamination.
5 reports on this incident · first at Sep 1, 2026, 10:50 p.m. ET
Earlier reports
Sep 1, 2026, 11:26 p.m. ET
FDA Reclassifies Medline Ultrasound Breast Pack Recall as Class II
The U.S. Food and Drug Administration (FDA) has changed the hazard classification for the Medline Ultrasound Breast Pack recall to Class II, according to a report from Medical Daily. The agency's classification indicates that the product may cause temporary or medically reversible adverse health consequences, though the FDA recall records reviewed for this report do not report injuries.
The recall, initiated on June 12, 2026, affects 300 kits distributed nationwide. The reason for the recall is that wrinkles in the paper lidding of the pouch may extend into the seal area, potentially exposing patients and users to microbial contamination. The affected products are identified by codes DYNJ63375C and 23LMC035.
The FDA advises checking stock, quarantining affected product, and submitting a response form. The recall status remains open as of the report date of August 31, 2026.
Sep 1, 2026, 11:23 p.m. ET
FDA Reports Injuries in Medline Ultrasound Breast Pack Recall
The FDA's recall records for Medline Ultrasound Breast Packs now report injuries, according to medicaldaily.com. The agency's records reviewed for this report do not specify the number or nature of the injuries.
The recall, initiated June 12, 2026, and classified as Class II, covers 300 kits distributed nationwide. The reason for the recall is that wrinkles in the paper lidding of the pouch may extend into the seal area, potentially exposing patients and users to microbial contamination. The affected kits are identified by codes DYNJ63375C and 23LMC035.
The FDA advises checking stock, quarantining affected product, and submitting a response form. The recall status remains open as of the report date of August 31, 2026.
Sep 1, 2026, 10:52 p.m. ET
FDA Closes Medline Ultrasound Breast Pack Recall
The U.S. Food and Drug Administration has closed the recall of Medline Ultrasound Breast Packs, according to Medical Daily. The agency considers the recall carried out. The recall, initiated June 12, 2026, was classified as Class II and affected 300 kits distributed nationwide.
The kits, pre-assembled sterile convenience kits for ultrasound-guided breast procedures, were recalled because wrinkles in the paper lidding of the pouch may extend into the seal area, potentially exposing patients and users to microbial contamination. The FDA recall records reviewed for this report do not report injuries.
Anyone still holding affected product should check stock, quarantine affected product, and submit a response form, as directed in the recall notice. Identifying codes are DYNJ63375C and 23LMC035.
Sep 1, 2026, 10:50 p.m. ETFirst report
Medline Recalls Ultrasound Breast Packs Over Sterile Barrier Concern
Medline has initiated a recall of its Ultrasound Breast Pack, a pre-assembled sterile convenience kit used in ultrasound-guided breast procedures, according to a report from Medical Daily. The recall, initiated on June 12, 2026, affects 300 kits distributed nationwide. The FDA has classified this as a Class II recall, as reported by Medical Daily.
The reason for the recall is that wrinkles in the paper lidding of the pouch may extend into the seal area, potentially exposing patients and users to microbial contamination. The affected products are identified by codes DYNJ63375C and 23LMC035. The FDA recall records reviewed for this report do not report any injuries.
The FDA advises users to check stock, quarantine affected product, and submit a response form. The recall status is open, and the report date is August 31, 2026.
Was this report accurate and useful?
Sources
Revision history
- Version 12 Sept 2026, 03:31current
First published.
- Version 12 Sept 2026, 02:50current
First published.
- Version 12 Sept 2026, 03:23current
First published.
- Version 12 Sept 2026, 03:26current
First published.
- Version 12 Sept 2026, 02:52current
First published.
How we work
This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.
Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.
Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.
None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.