Medline SPINE PACK-LF Kit Recall
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 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, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,083 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.