Medline SPINE PACK-LF Kit Recall

Source: FDA · Worldwide

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Medline Industries is recalling 104 medical procedure kits due to higher-than-expected endotoxin levels in the included neuro sponges.

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

This notice was issued by FDA on May 13, 2026 and geographically references Worldwide. 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 is recalling certain medical procedure kits because of higher-than-expected endotoxin levels identified in a representative Medline neuro sponge product, indicating that the in-market product may be out-of-specification for endotoxin.

Which Products Are Affected

The affected products are Medline medical procedure kits labeled as SPINE PACK-LF, with Medline Kit Number/SKU PHS719414B. A total of 104 kits are involved, distributed worldwide, with lot numbers: 22GBF198, 22DBU132, 22ABJ303, 21GBV167, 21GBV186, and 21BBL371. The codes include UDI/DI for each as 10889942214112 and for the case as 40889942214113.

What You Should Do

Consumers should contact Medline Industries, LP for instructions, as the recall was initiated through methods such as email, fax, letter, press release, telephone, or visit.

Why This Matters

This recall involves 104 kits that may not meet endotoxin specifications, potentially affecting product safety for users in worldwide distribution.

Source

Attributed to the FDA, recall number Z-2012-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries is recalling 104 medical procedure kits due to higher-than-expected endotoxin levels in the included neuro sponges.
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 "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. 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.