Recall archive / FDA device enforcement

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline... — FDA record Z-2015-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Classification: Class II
Recalling firm: Medline Industries, LP
Quantity: 3170 kits
Agency-reported status: Ongoing
Source record identifier: Z-2015-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23IME618; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23FMF542; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23DMA094; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23AMD730; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22GMB685; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMI233; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMC612; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 24AMA230; Medline Kit Number/SKU DYNJ51637D: UDI/DI each 10195327632106, UDI/DI case 40195327632107, Lot Number: 24GMI248; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JMK002; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JME739; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23IBJ883; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23EBO648; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23ABT378; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22KBG029; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22JBF057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22IBL935; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22FBD348; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22DBP280; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22BBB689; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22ABT749; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21KBX317; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBZ013; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBB969; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21IBB479; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21GBL057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21BBL823; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 26AMH608; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25LMB913; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25HMI678; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25GMK494; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25FMH605; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25DMA861; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25BMB215; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24JMJ380; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24FMD882; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24EMD977; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24DMF834; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24BMJ374; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23LMF318.

Label field

Details supplied by the agency

Lot, code or applicability

Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23IME618; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23FMF542; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23DMA094; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23AMD730; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22GMB685; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMI233; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMC612; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 24AMA230; Medline Kit Number/SKU DYNJ51637D: UDI/DI each 10195327632106, UDI/DI case 40195327632107, Lot Number: 24GMI248; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JMK002; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JME739; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23IBJ883; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23EBO648; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23ABT378; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22KBG029; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22JBF057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22IBL935; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22FBD348; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22DBP280; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22BBB689; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22ABT749; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21KBX317; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBZ013; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBB969; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21IBB479; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21GBL057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21BBL823; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 26AMH608; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25LMB913; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25HMI678; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25GMK494; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25FMH605; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25DMA861; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25BMB215; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24JMJ380; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24FMD882; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24EMD977; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24DMF834; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24BMJ374; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23LMF318.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: May 6, 2026
Recall initiation date: Mar 19, 2026
Center classification date: Apr 30, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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