Medline Industries Recalls Basic Nerve Block Trays Due to Sterilization Calibration Issues
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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 April 6, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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 ↗
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