Medline Industries Recalls Basic Nerve Block Trays Due to Sterilization Calibration Issues

Source: FDA · United States

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Medline Industries, LP has issued a voluntary recall for 448 units of Basic Nerve Block Trays after identifying equipment calibration errors that may compromise product sterility.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 4, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Medline Industries, LP has initiated a voluntary recall of specific medical convenience kits due to calibration issues identified in the equipment used for sterilization and packaging. While the products were processed through validated sterilization cycles, the calibration discrepancies have the potential to impact the Sterility Assurance Level (SAL) of the devices, meaning the products may not meet required sterility standards.

Which Products Are Affected

The recall specifically involves the following product:

  • Product Name: Medline Convenience Kits: BASIC NERVE BLOCK TRAY W/LINEN
  • Model Number: PAIN0150C
  • Lot Number: 21JBV886
  • UDI-DI: 10193489819571 (individual units), 21JBV886 (case)
  • Recall Number: Z-1387-2026
  • Quantity: 448 units

The affected kits were distributed nationwide across the United States and to international locations.

What You Should Do

Healthcare facilities and distributors should immediately check their inventory for the affected lot number (21JBV886). Medline has initiated notification to customers via a formal letter. Any units from the recalled lot should be quarantined and not used for patient care. For further instructions on returns or to report issues, contact Medline Industries, LP at their headquarters in Northfield, Illinois.

Why This Matters

Sterility is critical for medical devices used in invasive procedures like nerve blocks. A failure to maintain the proper Sterility Assurance Level increases the risk of patient infection and related medical complications.

Source

Information provided by the FDA.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP has issued a voluntary recall for 448 units of Basic Nerve Block Trays after identifying equipment calibration errors that may compromise product sterility.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.