Recall of Medline Microdiscectomy Packs Due to Endotoxin Levels
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Medline Industries is recalling 924 medical procedure kits containing neuro sponges because of higher-than-expected endotoxin levels, which may affect product safety.
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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Recall of Medline Medical Procedure Kits
What Happened
Medline Industries, LP initiated a voluntary recall after an internal review revealed higher-than-expected endotoxin levels on a representative neuro sponge product, indicating that in-market kits may be out-of-specification for endotoxin.
Which Products Are Affected
The affected products are Medline medical procedure kits labeled as MICRODISECTOMY PACK with the following kit numbers/SKUs: DYNJ80585B, DYNJ80585C, and DYNJ80585D. A total of 924 kits are involved, distributed worldwide. Specific details include: For DYNJ80585B: UDI/DI each 10195327211158, UDI/DI case 40195327211159, Lot Numbers 22GBV101 and 24IBG473; For DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Numbers 25EBT656, 25DBN421, 25CBN640, 25BBL172, 25BBD651, 25ABA455, 24KBO858, and 24JBH693; For DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Numbers 26ABH754, 25LBA242, 25HBT362, 25GBL430, and 25FBT402. The recall was initiated on March 19, 2026.
What You Should Do
Consumers who have the affected kits should follow the firm's initial notification, which may include email, fax, letter, press release, telephone, or visit, and contact Medline Industries, LP for instructions on returns or refunds.
Why This Matters
This recall involves medical devices that could pose risks if used in procedures due to potential endotoxin issues, affecting 924 kits distributed worldwide and highlighting the importance of quality control in healthcare products.
Source
This information is attributed to the FDA with Recall Number Z-2030-2026.
Original source: FDA Official Notice ↗
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