FDA Closes Medline Neuro Kit Recall Over Endotoxin Levels

The FDA has terminated its enforcement action on 3,468 Medline neurological convenience kits recalled for potential out-of-specification endotoxin levels in the neurosponges they contain.

2 reports on this incident · first at Sep 9, 2026, 8:48 p.m. ET

By AI ReporterWritten Sep 9, 2026, 8:53 p.m. ET

The FDA has closed its enforcement action on a recall of Medline medical convenience kits, according to the agency's enforcement report for recall number . The action, classified as , was initiated on July 8, 2026, and reported on September 2, 2026. The agency considers the recall carried out. The recall covered 3,468 kits distributed nationwide in Arizona, California, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Texas, Wisconsin and Wyoming, according to the enforcement report. The reason given in the report is that specific items and lots of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips were recalled due to potential out-of-specification levels of endotoxin of the neurosponges. is the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote, according to the agency's recall definitions. The affected products, as listed in the enforcement report, are Medline medical convenience kits labeled NEURO CDS (SKU CDS985246J), NEURO PACK (SKU DYNJ32770V), NEURO BUNDLE-LF (SKU DYNJ40095D), NEURO PACK-LF (SKU DYNJ42844D), NEURO PACK (SKU DYNJ45121I), NEURO LAMINECTOMY PACK (SKU DYNJ58012A), NEURO PACK SJ (SKU DYNJ63477A) and BASIC NEURO PACK (SKU DYNJ83071A). The report lists the following UDI/DI codes: 10193489232394 (each) and 40193489232395 (case) for CDS985246J; 10195327090111 (each) and 40195327090112 (case) for DYNJ32770V; 10195327281250 (each) and 40195327281251 (case) for DYNJ40095D; 10193489880564 (each) and 40193489880565 (case) for DYNJ42844D; 10193489887631 (each) and 40193489887632 (case) for DYNJ45121I; 10193489863994 (each) and 40193489863995 (case) for DYNJ58012A; 10195327123451 (each) and 40195327123452 (case) for DYNJ63477A; and 10195327452490 (each) and 40195327452491 (case) for DYNJ83071A. The report lists the following lot numbers: 22HMB295, 22IMB860, 22FMB806, 23GMI744, 25EBV362, 25CMH980, 25FMB096, 25GMA066, 25GMH940, 25BMI081, 25IMC735, 24DME519, 24EMG256, 24GMJ491, 24IMA243, 24JMA162, 24JMD784, 24KMI470, 24ABN077, 24ABN475, 24DBA116, 23AMH395, 23EMA407, 23HBH164, 23HBO192, 23HBV863, 23IBF802, 23IBS028, 23JBV613, 22BME230, 22CMA406, 22EMB248, 22EMI134, 22HME564, 22IMA455, 22JMI068, 22LMB601, 24BMI624, 24EME751, 23AMJ022, 23CMB364, 23EMD743, 23FMH669, 23JME474, 22DMH314, 22LME727, 22EMB958, 22EMC777 and 23HMF326. The firm is , of , Illinois, according to the enforcement report. The agency's database records no other enforcement action by this firm.

Earlier reports

Sep 9, 2026, 8:48 p.m. ETFirst report
Medline Recalls 3,468 Neuro Surgery Kits Over Endotoxin Levels
Medline Industries, LP of Northfield, Illinois, is recalling 3,468 neuro medical convenience kits because they contain Pilling Wecksorb Neurosponges and Neurosponge Strips with potential out-of-specification levels of endotoxin, according to an FDA enforcement report dated September 2, 2026. The recall, number Z-2996-2026, is classified as Class II and remains ongoing.
The affected products are eight Medline kit SKUs: CDS985246J (NEURO CDS), DYNJ32770V (NEURO PACK), DYNJ40095D (NEURO BUNDLE-LF), DYNJ42844D (NEURO PACK-LF), DYNJ45121I (NEURO PACK), DYNJ58012A (NEURO LAMINECTOMY PACK), DYNJ63477A (NEURO PACK SJ), and DYNJ83071A (BASIC NEURO PACK). The FDA report lists specific lot numbers for each SKU, including 22HMB295, 22IMB860, 22FMB806, 23GMI744, 25EBV362, 25CMH980, 25FMB096, 25GMA066, 25GMH940, 25BMI081, 25IMC735, 24DME519, 24EMG256, 24GMJ491, 24IMA243, 24JMA162, 24JMD784, 24KMI470, 24ABN077, 24ABN475, 24DBA116, 23AMH395, 23EMA407, 23HBH164, 23HBO192, 23HBV863, 23IBF802, 23IBS028, 23JBV613, 22BME230, 22CMA406, 22EMB248, 22EMI134, 22HME564, 22IMA455, 22JMI068, 22LMB601, 24BMI624, 24EME751, 23AMJ022, 23CMB364, 23EMD743, 23FMH669, 23JME474, 22DMH314, 22LME727, 22EMB958, 22EMC777, and 23HMF326. The kits were distributed nationwide in Arizona, California, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Texas, Wisconsin, and Wyoming.
Class II is the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote, according to the agency's recall definitions. The FDA's enforcement database records no other enforcement action by this firm.

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Version 110 Sept 2026, 00:48current
First published.
Version 110 Sept 2026, 00:53current
First published.

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