Medline BASIC NERVE BLOCK TRAY W/LINEN Recall
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Medline Industries is recalling 448 units of BASIC NERVE BLOCK TRAY W/LINEN convenience kits due to potential sterility assurance issues from equipment calibration problems.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "medium" 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Medline Industries, LP has initiated a voluntary recall due to issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
Which Products Are Affected
- Product: Medline Convenience Kits: BASIC NERVE BLOCK TRAY W/LINEN
- Model Number: PAIN0150C
- Lot Number: 21JBV886
- UDI-DI: 10193489819571 (each), 40193489819572 (case)
- Quantity: 448 units
- Distribution: US Nationwide distribution (Worldwide)
- Recall Number: Z-2116-2026
- Classification: Class II
What You Should Do
No specific consumer action steps are provided in the recall notice. The recall is ongoing and was initiated by the firm via letter on January 7, 2026.
Why This Matters
The calibration issues have the potential to impact the sterility assurance level of the affected medical devices distributed nationwide.
Source
FDA recall Z-2116-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
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