Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO, — FDA record Z-2033-2026

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 (961 in total), NEURO,
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
538201 kits
Agency-reported status
Ongoing
Source record identifier
Z-2033-2026

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 CDS780056K: UDI/DI each 10888277941373, UDI/DI case 40888277941374, Lot Number: 21DBU610; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21KBG946; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21IBV394; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23IBO480; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23FBL915; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23EBP966; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23DBB223; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23CBO553; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23ABG956; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22KBD840; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22IBK666; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22HBZ276; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22GBK671; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22FBI951; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22EBE862; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22OBA987; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22BBC815; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21KBC808; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21HBM967; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21FBD640; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBN004; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBB965; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBU070; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBS617; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABT989; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABR939; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABE858; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBU114; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBB359; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBA010; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBP286; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBI821; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26BBJ914; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26ABU117; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25KBB123; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25JBJ200; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25GBX170; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25GBD249; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25FBV077; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25FBB825; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25BBS499; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25ABF429; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 24LBK961; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 23ABU440; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 23ABM574; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22KBM775; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22IBN540; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22HBH464; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22EBM543; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22DBL468; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22BBQ627; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22ABH903; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 21FBD429; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23HMF568; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23GMD696; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23EMG749; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23EMF336; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23DMG955; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23DMB891; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23BMF118; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22EMF683; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22CMB893; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22AME418; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22AMB644; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21HMG159; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21GMD475; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21EME444; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21CKA528; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 24CMH800; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 24AME651; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25EMC695; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25DMH430; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25CMC383; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25BMA577; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24LMF931; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24IMI022; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24HMD414; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24GMF641; Medline Kit Number/SKU CDS780230M: UDI/DI each 10198459371530, UDI/DI case 40198459371531, Lot Number: 25LMB182; Medline Kit Number/SKU CDS780230M: UDI/DI each 10198459371530, UDI/DI case 40198459371531, Lot Number: 25JME944; Medline Kit Number/SKU CDS840193AA: UDI/DI each 10198459624650, UDI/DI case 40198459624651, Lot Number: 26BBI688; Medline Kit Number/SKU CDS981327Q: UDI/DI each 10195327080365, UDI/DI case 40195327080366, Lot Number: 22IMA515; Medline Kit Number/SKU CDS981327Q: UDI/DI each 10195327080365, UDI/DI case 40195327080366, Lot Number: 22GMH480; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25DMA275; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25CMC073; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25BMH093; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25AMJ526; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24KMC461; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24JMG627; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24IMA421; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24FMJ886; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24FMI364; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24FMC468; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24EMJ857; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24DME653; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24DME236; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 23LMH592; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 26BMD798; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 26AMJ740; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 26AMK056; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25KME621; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25HMI011; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25GMD593; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25EMJ777; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21KMB552; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21JMA057; Medline Kit Number...

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.

Related records