Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medli... — FDA record Z-2016-2026

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. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993M; 5. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933G; 6. FESS-MB PACK-LF, Medline Kit Number/SKU DYNJ0888159I; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861C; 8. POSTERIOR LUMBAR PACK, Medline Kit Number/SKU DYNJ42626B; 9. CV CUTDOWN PACK, Medline Kit Number/SKU DYNJ45374F; 10. X RAY CLOSED PACK, Medline Kit Number/SKU DYNJ48949C; 11. RFD- AAA PACK, Medline Kit Number/SKU DYNJ54242B; 12. NEURO LAM, Medline Kit Number/SKU DYNJ64188A; 13. LIVE OAK SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ69223; 14. FEM POP PACK, Medline Kit Number/SKU DYNJ81423C; 15. ENS FREEFLAP PROCDURE - LF, Medline Kit Number/SKU DYNJ88249; 16. OPEN HEART A&B, Medline Kit Number/SKU DYNJ901203D; 17. NEURO ACD, Medline Kit Number/SKU DYNJ904549F; 18. KIT VP SHUNT RFD, Medline Kit Number/SKU DYNJ906303F; 19. ACDF-LF, Medline Kit Number/SKU DYNJ906681C; 20. ACDF-LF, Medline Kit Number/SKU DYNJ906681D; 21. ACDF-LF, Medline Kit Number/SKU DYNJ906681F; 22. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196B; 23. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196C; 24. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362F; 25. VP SHUNT, Medline Kit Number/SKU DYNJ909379; 26. VP SHUNT, Medline Kit Number/SKU DYNJ909379A.
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
4016 kits
Agency-reported status
Ongoing
Source record identifier
Z-2016-2026

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 CDS840402AI: UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA668; Medline Kit Number/SKU CDS840402AI: UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA240; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25IMG470; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMI158; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMC404; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ILA647; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23HLA953; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23GLA064; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ELA715; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22KLB111; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22GLB222; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ELA384; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ELA314; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22CLA246; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22BLA951; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ALB037; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21KLA949; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21KLA323; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21JLA776; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21ILA612; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21HLA761; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21CKA431; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21AKA070; Medline Kit Number/SKU DYNJ0750993M: UDI/DI each 10195327196721, UDI/DI case 40195327196722, Lot Number: 22HMA046; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 25BMB856; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 25BMA099; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24KMD499; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24IMH163; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24FMC456; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24EMF287; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24DBR793; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23IMH609; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23FMI503; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23EMF428; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23CMG922; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23BMB904; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23BMB800; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23AMG570; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 22CLA968; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 21LLA678; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 21LLA280; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23LMA074; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 23KMB808; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 23FMG346; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 22JME917; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 25BME921; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 24KMI331; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 24GMJ067; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 24CMD306; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 23KMJ792; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 23DMA752; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 23AMJ467; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 23AME117; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22LMH958; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22FMI351; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22DMG917; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22DME926; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22CME836; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22CME845; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22AMB811; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21LMC202; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21IMF079; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21HMG746; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21HMB707; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21GMA214; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21FMD947; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21EME446; Medline Kit Number/SKU DYNJ42626B: UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21DMA825; Medline Kit Number/SKU DYNJ45374F: UDI/DI each 10195327235338, UDI/DI case 40195327235339, Lot Number: 22HLB315; Medline Kit Number/SKU DYNJ48949C: UDI/DI each 10195327506421, UDI/DI case 40195327506422, Lot Number: 24EMG463; Medline Kit Number/SKU DYNJ54242B: UDI/DI each 10195327167097, UDI/DI case 40195327167098, Lot Number: 22EBN455; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 22FBC048; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 22EBL053; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 22ABY741; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 21LBR909; Medline Kit Number/SKU DYNJ64188A: UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 21GBN579; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 23FBK303; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 23DBJ838; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 23BBG277; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 22LBR825; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 21HBA373; Medline Kit Number/SKU DYNJ69223: UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 21GBK168; Medline Kit Number/SKU DYNJ81423C: UDI/DI each 10195327580971, UDI/DI case 40195327580972, Lot Number: 24ALA997; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 25HBG788; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 25EBH390; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 25DBO029; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 24JBJ805; Medline Kit Number/SKU DYNJ88249: UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 24IBP006; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 26CMA719; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25KMA819; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25JMI928; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25IMH651; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25IMF255; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25EMC697; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25EMA738; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 24LMF802; Medline Kit Number/SKU DYNJ901203D: UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 24KMI436; Medline Kit Number/SKU DYNJ904549F: UDI/DI each 10193489296518, UDI/DI case 40193489296519, Lot Number: 21BBN341; Medline Kit Number/SKU DYNJ906303F: UDI/DI each 10195327370961, UDI/DI case 40195327370962, Lot Number: 23KBC207; Medline Kit Number/SKU DYNJ906303F: UDI/DI each 10195327370961, UDI/DI case 40195327370962, Lot Number: 24CBF368; Medline Kit Number/SKU DYNJ906303F: UDI/DI each 10195327370961, UDI/DI case 40195327370962, Lot Number: 24BBS806; Medline Kit Number/SKU DYNJ906681C: UDI/DI each 10195327173838, UDI/DI case 40195327173839, Lot Number: 24KBP901; Medline Kit Number/SKU DYNJ906681C: UDI/DI each 10195327173838, UDI/DI case 40195327173839, Lot Number: 24JBS832; Medline Kit Number/SKU DYNJ906681C: UDI/DI each 10195327173838, UDI/DI case 40195327173839, Lot Number: 24JBS844; Medline Kit Number/SKU DYNJ906681D: UDI/DI each 10198459177835, UDI/DI case 40198459177836, Lot Number: 25EBT919; Medline Kit Number/SKU DYNJ906681D: UDI/DI each 10...

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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