FirstAlerts
Recalls & Safety AlertsVersion 6

Medline Recalls 1,601 Surgical Convenience Kits Over Possible Bacillus Contamination

An FDA enforcement report lists nine kit types containing BD PurPrep 26 mL as Class II, with the recall still ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:15 a.m. ET
has recalled 1,601 units of surgical convenience kits because specific kits containing BD PurPrep 26 mL "may be contaminated with low levels of Bacillus species," according to the FDA enforcement report for recall number . That record lists the recall as initiated on 11 June 2026, with a report date of 29 July 2026, and its status as . The FDA classified the recall as . Under the agency's own definitions, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The enforcement record lists nine kit types: TOTAL JOINT PACK (SKU DYNJ65065A, UDI/DI 10193489317244 each, 40193489317245 case), EXTREMITY/FOOT PACK (DYNJ65066B), ANTERIOR CERVICAL-SMH (DYNJ907718B), LAMINECTOMY-SMH (DYNJ907732C), KYPHOPLASTY (DYNJ907984C), LUMBAR LAMINECTOMY (DYNJ907987D), KYPHOPLASTY TRAY (DYNJ908413C), CRANIOTOMY (DYNJ910626) and NEURO SPINE (DYNJ910639), each with specified lot numbers — among them 24KMI926, 25BMI009, 25DME458 and 25FMC143 for DYNJ65065A, and 25EBD582 and 25FBM835 for DYNJ908413C. Distribution is recorded in the United States only: Connecticut, Florida, Kansas, Ohio, Oregon, New York, Maryland, Montana, Virginia and Massachusetts. A convenience kit is defined in the US device rules as two or more different medical devices packaged together for the convenience of the user (21 CFR 801.3), a definition set out in FDA guidance published in the Federal Register; the agency has treated medical procedure kits, including orthopedic procedure kits, as falling in that category. Patent literature describing such packs lists typical contents as drapes and table covers, gowns, towels, gauze and sponges, basins, suction handles and tubing, syringes and needles and other single-use plastic devices, laid out on a base tray and wrapped so the contents can be opened onto a sterile field. They are not consumer products: procedure packs are bought under supply contracts by hospitals, surgical centres and health systems and are opened by operating-room staff. The names on the packs — total joint, extremity/foot, anterior cervical, laminectomy, kyphoplasty — are simply the procedures the contents were assembled for, and the SKU is the assembler's catalogue number. The FDA's enforcement database records no other enforcement action by this firm, which says nothing about fault in this action. The report does not state how the possible contamination arose, and no cause has been determined.

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Revision history

  1. Version 67 Aug 2026, 14:15current

    Tightened lead and removed the redundant "action is still developing" line; no factual changes.

  2. Version 57 Aug 2026, 11:08

    Replaced the TGA/AORN description of procedure packs with the sourced FDA guidance and patent-literature background, and adjusted sources cited accordingly.

  3. Version 47 Aug 2026, 05:53

    Replaced the AHRMM and NHS Supply Chain descriptions of convenience kits with the FDA guidance, TGA and AORN sources, and added the medical procedure kit definition and pack-configuration detail.

  4. Version 37 Aug 2026, 01:35

    Expanded the explanation of what a convenience kit contains and how it is sold, citing the NHS Supply Chain procedure-pack brief; other facts unchanged.

  5. Version 26 Aug 2026, 22:08

    Added UDI/DI codes and the kit-assembler detail from FDA's definition; corrected background sourcing to the Federal Register notice and AHRMM brief.

  6. Version 16 Aug 2026, 15:06

    First published.

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