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Recalls & Safety AlertsVersion 6

FDA Classifies Recall of 60 Medline Anterior Hip Surgical Kits as Class I

The agency's enforcement report for recall Z-2747-2026 traces the action to a voluntary recall of a bupivacaine injection supplied within the kits.

By AI ReporterUpdated Aug 7, 2026, 10:26 a.m. ET
The U.S. Food and Drug Administration has classified as a recall of 60 Medline anterior hip surgical kits, according to the agency's enforcement report for recall number . The record lists as the recalling firm, an initiation date of June 5, 2026, and a report date of July 29, 2026. The status is listed as , and this account is based on that record as it currently stands. The enforcement record identifies the product as , lot number 25DBF430, with UDI/DI 10198459280559 for each unit and 40198459280550 for the case. Distribution is listed in the United States in Ohio, California, Illinois, Indiana, Florida, South Carolina, Arizona and New Jersey. A kit of this kind is a single-use surgical "convenience kit" — a sealed, pre-sterilised package holding the disposable items an operating-room team lays out for one anterior-approach hip replacement. Under the FDA's own definition, a convenience kit is two or more different medical devices packaged together for the user's convenience, intended to stay packaged together and not be repackaged or re-sterilised before use; such kits may contain surgical instruments, drapes, dressings, other materials and, in some cases, pharmaceutical components, according to FDA guidance and the agency's description of the definition at 21 CFR 801.3. These are institutional supply items built to a hospital's specified contents and sold in case quantities to hospitals and surgical centres; a member of the public cannot meaningfully buy one. The code DYNJ909640G is the pack's catalogue number, identifying one pack configuration rather than a single object. That background describes the product generally and says nothing about this recall. The stated reason in the enforcement record is that is recalling specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. According to the record, B. Braun Medical Inc. was notified by its supplier, Spectra Medical Devices, LLC, of a product recall from Huons Co, Ltd., the manufacturer of the bupivacaine injection, and Huons Co, Ltd. has issued a voluntary recall of that product due to quality issues. The record does not specify the nature of those quality issues. The FDA defines as its most serious recall category, used where there is a reasonable probability that use of the product will cause serious harm or death. The agency's enforcement database records no other enforcement action by this firm; that fact says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:26current

    No new facts in the record; headline and dek sharpened, text otherwise unchanged.

  2. Version 57 Aug 2026, 10:12

    Replaced the AccessGUDID/product-code description of the kit with the FDA's convenience-kit definition and guidance, including how such kits are sold and to whom.

  3. Version 47 Aug 2026, 06:39

    Added a paragraph explaining what an anterior hip procedure tray is, sourced to AccessGUDID and FDA device-database records.

  4. Version 37 Aug 2026, 00:45

    Removed the unsourced explanatory section describing surgical procedure kits; added a line noting the record does not specify the nature of the quality issues.

  5. Version 26 Aug 2026, 20:10

    Replaced the unsourced 21 CFR 801.3 "convenience kit" explanation with the sourced AccessGUDID and patent-literature description of the surgical procedure tray, and added the supporting reference URLs.

  6. Version 16 Aug 2026, 15:26

    First published.

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