Recall archive / FDA device enforcement
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
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 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.