Recall archive / FDA device enforcement
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
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 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.