FirstAlerts
Recalls & Safety AlertsVersion 6

Medline Recalls 398 Surgical Convenience Kits Over Possible Contamination in Antiseptic Component

An FDA enforcement report lists the recall as Class II and ongoing, covering shoulder and major orthopedic packs distributed in ten states.

By AI ReporterUpdated Aug 7, 2026, 9:46 a.m. ET
is recalling 398 medical convenience kits after the antiseptic component packed inside them was found possibly contaminated with low levels of Bacillus species, according to an FDA enforcement report carrying recall number . The report gives the reason as specific Medline convenience kits containing BD PurPrep 26 mL that may be contaminated. The recall was initiated on June 11, 2026, and the enforcement report is dated July 29, 2026. The FDA record lists the recall status as . The products are listed as three kit types: SHOULDER PACK, Medline Kit SKU DYNJ39590O; SHOULDER PACK, Medline Kit SKU DYNJ88566; and MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535. The record lists UDI/DI 10198459187780 (each) and 40198459187781 (case) for DYNJ39590O, with lot numbers 25GBE239, 24LBF187, 25ABM992, 25CBJ129 and 25DBI743; UDI/DI 10198459179235 (each) and 40198459179236 (case) for DYNJ88566, lot number 24KBK487; and UDI/DI 10198459377600 (each) and 40198459377601 (case) for DYNJ911535, lot number 25FBU802. Distribution is listed in ten U.S. states: Connecticut, Florida, Kansas, Ohio, Oregon, New York, Maryland, Montana, Virginia and Massachusetts. The FDA classified the recall as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. These are not consumer goods. Under 21 CFR 801.3, cited in FDA guidance on unique device identification, a convenience kit is two or more different medical devices packaged together for the convenience of the user, sealed in a single container and intended to be opened only at the point of use. Patent and clinical descriptions of such custom procedure kits list ordinary single-use operating-room supplies — drapes and covers, gowns, towels, gauze, tubing and syringes — assembled, packaged and sterilized to a hospital's specification. The kit names here indicate the intended procedure: two shoulder-surgery packs and one major orthopedic kit. They are sold business-to-business to hospitals and surgical facilities, often under supply contracts or tenders, and would not be bought or handled by members of the public. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.

Was this report accurate and useful?

Sources

Revision history

  1. Version 67 Aug 2026, 13:46current

    Added headline and dek; trimmed the convenience-kit definition to the sourced wording and tightened the background paragraph.

  2. Version 57 Aug 2026, 09:58

    Added description of typical convenience-kit contents and how the kits are sold, from FDA guidance and patent references; tightened the explanatory paragraph.

  3. Version 47 Aug 2026, 06:49

    Replaced the patent-derived list of kit contents with the FDA guidance definition of a convenience kit and its packaging and UDI conditions, and added the supporting source URLs.

  4. Version 37 Aug 2026, 00:38

    Replaced the unsourced 21 CFR 878.4370 drape definition and paraphrased kit guidance with the supplied 21 CFR 801.3 definition and patent-derived description, added source URLs, and trimmed the unsupported 'still developing' line.

  5. Version 26 Aug 2026, 19:59

    Replaced the unsupported 21 CFR 801.3 convenience-kit definition and National Library of Medicine reference with FDA guidance and 21 CFR 878.4370 surgical drape wording, and added source URLs.

  6. Version 16 Aug 2026, 15:09

    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.