Medline Medical Procedure Kits Recall Over Endotoxin Levels
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Medline Industries is recalling 10,400 medical procedure kits due to higher-than-expected endotoxin levels in the included Medline 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 an internal review identified higher-than-expected endotoxin levels on a representative Medline Neuro Sponge product, indicating that in-market products may be out-of-specification for endotoxin.
Which Products Are Affected
The affected products are Medline medical procedure kits containing Medline Neuro Sponges, labeled as SPNG NEURO 1X1 10/PK XR, with Medline Kit Number/SKU DNSC38133. The recall involves 10,400 kits with UDI/DI for each at 10884389388655 and for cases at 40884389388656. The specific lot numbers are: 22KDA794, 22JDB440, 22ADA361, 22ADA101, 21LDC095, 21LDA462, 21JDC613, 21JDB279, 21IDC073, 21FDA437, 21EDC004, 21EDC005, 21EDB599, 21DDA592, 21CDA826, and 21BDA565. These products were distributed worldwide.
What You Should Do
Consumers should follow the initial firm notifications from Medline Industries, which include two or more of the following methods: email, fax, letter, press release, telephone, or visit, as this is a voluntary firm-initiated recall.
Why This Matters
This recall involves 10,400 kits with potential out-of-specification endotoxin levels, which could affect product safety for users in worldwide distribution.
Source
Attribution: FDA Recall Number Z-2032-2026. For more information, refer to the FDA website.
Original source: FDA Official Notice ↗
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