Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC,... — FDA record Z-2027-2026

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 (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
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
263739 kits
Agency-reported status
Ongoing
Source record identifier
Z-2027-2026

Open the official record

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

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityMedline Kit Number/SKU BIOB110: UDI/DI each 10889942758043, UDI/DI case 40889942758044, Lot Number: 24HBM826; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23KBK939; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23JBD164; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23HBJ252; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23EBV328; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23DBD983; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBR624; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBM647; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBB199; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23ABR879; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23ABK516; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22KBO464; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22IBD725; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22FBH811; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22DBG358; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22CBS385; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22ABG822; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24CBK278; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24CBG921; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24BBM090; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24ABK179; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 26ABC519; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25JBY144; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25GBU677; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25FBK528; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25EBM571; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25DBA260; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25BBD145; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24KBA043; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24JBQ514; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24JBE904; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24HBT002; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 23ABC251; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 23ABA109; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22LBG189; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22JBH395; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22IBH148; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22IBH149; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22HBK033; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22FBP720; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22EBF677; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22EBE578; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21KBC814; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21IBG791; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21GBM673; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21EBN323; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21EBE906; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23IBL699; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23IBF324; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23HBK824; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23HBI027; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23FBB361; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23DBH603; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23CBP031; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23BBT911; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22KBJ589; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22IBW083; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22IBU661; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22IBP415; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22HBH503; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22DBJ059; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22BBS783; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21LBE720; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21IBX894; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21HBF776; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21GBU819; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21FBS280; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21EBM597; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21BBI896; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23HBV227; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23EBX115; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23EBA159; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23CBS045; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23BBB544; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 22LBJ560; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 22KBJ947; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 22GBD058; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21LBX363; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21LBB483; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21GBP339; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21FBA018; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21DBO221; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25LBQ249; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25JBE076; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25IBH078; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25HBJ526; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25FBC545; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25ABM594; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25ABB924; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 24JBC331; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 24JBC484; Medline Kit Number/SKU CDS982719X: UDI/DI each 10198459064531, UDI/DI case 40198459064532, Lot Number: 24LBC587; Medline Kit Number/SKU CDS982719X: UDI/DI each 10198459064531, UDI/DI case 40198459064532, Lot Number: 24KBA129; Medline Kit Number/SKU CDS982719X: UDI/DI each 10198459064531, UDI/DI case 40198459064532, Lot Number: 24JBB766; Medline Kit Number/SKU CDS982719X: UDI/DI each 10198459064531, UDI/DI case 40198459064532, Lot Number: 24IBE288; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23GBE103; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23FBE548; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23EBG901; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23DBK554; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23CBQ213; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23CBI598; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23BBB052; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 22JBR311; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 22IBR028; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 22GBT501; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 22EBR711; Medline Kit Number/SKU...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

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.

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