FirstAlerts

FDA closes recall of Medline surgical kits over potentially contaminated component

The agency considers the recall carried out; consumers are urged to check the listed lot numbers.

2 reports on this incident · first at Sep 7, 2026, 8:11 p.m. ET

By AI ReporterWritten Sep 7, 2026, 8:24 p.m. ET
The U.S. Food and Drug Administration has closed the recall of 94 Medline surgical convenience kits that contained a potentially contaminated component, according to an FDA enforcement report dated September 2, 2026. The recall, numbered , was initiated July 10, 2026, and is classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote. The kits were distributed nationwide in Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, and Wisconsin. The affected products are: MAJOR PROCEDURE (SKU CDS982040U, lot 26AMC355), OPERATIVE LAP P&S SURGICAL (SKU DYNJ89608, lot 25JBR465), LAPAROSCOPY (SKU DYNJ903479L, lot 25LMB480), and LAPAROSCOPY (SKU DYNJ903479M, lot 26FMB173). The FDA database records no other enforcement action by , of , Illinois. The closure means the agency considers the recall carried out; anyone still holding these kits should check the lot numbers and follow the manufacturer's instructions.

Earlier reports

  1. Sep 7, 2026, 8:11 p.m. ETFirst report

    Medline recalls 94 surgical convenience kits over potentially contaminated component

    Medline Industries, LP, of Northfield, Illinois, is recalling 94 surgical convenience kits because they contain a potentially contaminated component that was recalled by the manufacturer, according to an FDA enforcement report dated September 2, 2026. The recall, listed as number Z-3022-2026, is ongoing and was initiated on July 10, 2026.

    The affected kits are labeled as MAJOR PROCEDURE (SKU CDS982040U), OPERATIVE LAP P&S SURGICAL (SKU DYNJ89608), and LAPAROSCOPY (SKUs DYNJ903479L and DYNJ903479M). The FDA lists specific lot numbers and UDI/DI codes for each kit. The kits were distributed nationwide in Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, and Wisconsin.

    The FDA classified the recall as Class II, its middle category, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote. The FDA's enforcement database records no other enforcement action by Medline Industries, LP.

    A surgical convenience kit is a consolidated, single-use package of medical devices and supplies used in operating rooms to set up sterile fields and access disposable instruments, according to product descriptions from medical supply sources. The kits are sold directly to healthcare facilities.

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Revision history

  1. Version 18 Sept 2026, 00:11current

    First published.

  2. Version 18 Sept 2026, 00:24current

    First published.

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