Medline Recalls Medical Procedure Kits Over Endotoxin Levels
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Medline Industries is voluntarily recalling 4,324 medical procedure kits due to potential higher-than-expected endotoxin levels in the included neuro sponges, 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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Medline Industries, LP is recalling certain medical procedure kits as part of a voluntary action initiated due to quality concerns with the products.
What Happened
Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product during an internal review, indicating that the 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, specifically: 1. SPINE PROCEDURES PACK-LF with SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF with SKU DYNJ47568B; 3. UROLOGY ROBOTIC with SKU DYNJ55555B; 4. UROLOGY ROBOTIC with SKU DYNJ55555C; and 5. UROLOGY ROBOTIC with SKU DYNJ55555D. A total of 4,324 kits are affected, with distribution worldwide. Specific lot numbers include: For DYNJ0751220P: 22EMB486, 22CMI117, 22CMB218, 22CMB219, 21LMA406, 21LMA805, 21JMF667, 21IMF752, 21HMG136, 21HMB278, 21GMD367, 21CKA503, 21AKA471; For DYNJ47568B: 23JBT331, 23IBL993, 23GBN118, 23FBQ324, 23EBO916, 23CBI861, 23BBE825, 23ABD998, 22LBA177, 22IBJ001, 22FBY332, 22FBX502, 22EBE351, 22ABO417, 21WBA306, 21KBG927, 21GBW059, 21GBW057, 21EBP877, 21EBP891, 26ABT067, 25LBO620, 25LBC010, 24KBR338, 24HBS302, 24HBR212, 24FBM377, 24EBC753, 24BBN421, 24BBG081, 23LBC938; For DYNJ55555B: 22ABW137, 22ABD653, 21LBN774; For DYNJ55555C: 22IBD321, 22HBB560, 22GBG766, 22DBU479; For DYNJ55555D: 23KBQ339, 23JBF048, 23EBX527, 23DBG858, 23CBX731, 23CBF699, 22LBJ888. UDIs for each are provided in the source data.
What You Should Do
Consumers and healthcare providers should contact Medline Industries, LP for instructions on the recall, as the firm has initiated notifications via email, fax, letter, press release, telephone, or visit. Follow the firm's guidance for returning or handling the affected products.
Why This Matters
This recall involves medical devices that could potentially expose users to endotoxins, which may lead to adverse health effects, highlighting the importance of quality control in healthcare products to ensure patient safety.
Source
This information is from the FDA recall notice with recall number Z-2034-2026. For more details, visit the FDA website at https://www.fda.gov/ and search for the recall using the event ID 98664.
Original source: FDA Official Notice ↗
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