Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline ... — FDA record Z-2022-2026

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. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069Q; 5. MINOR MB PACK-LF, Medline Kit Number/SKU DYNJ0429303L; 6. ENDOSCOPIC SKULL BASE PACK-LF, Medline Kit Number/SKU DYNJ0753948J; 7. RR-H&N FREEFLAP BLCKWELL PK-LF, Medline Kit Number/SKU DYNJ0785741K; 8. MINIMALLY INVASIVE PACK-LF, Medline Kit Number/SKU DYNJ0843063K; 9. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320K; 10. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320M; 11. MLD PACK, Medline Kit Number/SKU DYNJ19521Q; 12. SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ34623C; 13. PMD PACK SURG CNTR-LF, Medline Kit Number/SKU DYNJ35305G; 14. LARYNGOSCOPY PACK, Medline Kit Number/SKU DYNJ37547D; 15. FUNCTIONAL SINUS ENDOSCOPY, Medline Kit Number/SKU DYNJ40406A; 16. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645C; 17. FREE FLAP B PACK, Medline Kit Number/SKU DYNJ40648G; 18. MINOR ENT PACK, Medline Kit Number/SKU DYNJ50808A; 19. SINUS ENDOSCOPY PACK-LF, Medline Kit Number/SKU DYNJ52062; 20. LAP PACK, Medline Kit Number/SKU DYNJ52116B; 21. LAP PACK, Medline Kit Number/SKU DYNJ52116C; 22. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719C; 23. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719D; 24. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917I; 25. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917J; 26. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917K; 27. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917L; 28. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917N; 29. LARYNGOSCOPY WEST PACK, Medline Kit Number/SKU DYNJ58324A; 30. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558A; 31. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558B; 32. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213; 33. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213D; 34. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213G; 35. EENT PACK, Medline Kit Number/SKU DYNJ68366B; 36. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447; 37. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447A; 38. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447B; 39. UNIVERSITY DISC PACK, Medline Kit Number/SKU DYNJ69824; 40. MAJOR PACK, Medline Kit Number/SKU DYNJ81325; 41. MAJOR PACK, Medline Kit Number/SKU DYNJ81325A; 42. MAJOR PACK, Medline Kit Number/SKU DYNJ81325B; 43. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751; 44. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751A; 45. FLAP PACK, Medline Kit Number/SKU DYNJ85359; 46. ENDO PACK, Medline Kit Number/SKU DYNJ86125; 47. ENDO PACK, Medline Kit Number/SKU DYNJ86125A; 48. ENT PACK, Medline Kit Number/SKU DYNJ88448; 49. MAJOR BACK PACK, Medline Kit Number/SKU DYNJ88470; 50. UROLOGY DAVINCI, Medline Kit Number/SKU DYNJ901572O; 51. LARYNGOSCOPY/BRONCH, Me...
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
21288 kits
Agency-reported status
Ongoing
Source record identifier
Z-2022-2026

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 CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25EDA675; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25CDA718; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25BDA328; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDB408; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDA607; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23HMH658; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23GMD341; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23EMB793; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23CMG372; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23BMI499; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22JMF967; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22EMC648; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22CMD889; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24EMH897; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24DMF264; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24BMJ904; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24AMH650; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23IME074; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23IMA416; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23EME302; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23DMH071; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23CMH752; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23LME133; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25LMB574; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25IMG534; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25EMJ878; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25DME997; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25CMI768; Medline Kit Number/SKU DYNJ0429303L: UDI/DI each 10195327587260, UDI/DI case 40195327587261, Lot Number: 24HMH265; Medline Kit Number/SKU DYNJ0753948J: UDI/DI each 10193489895896, UDI/DI case 40193489895897, Lot Number: 21KMD078; Medline Kit Number/SKU DYNJ0753948J: UDI/DI each 10193489895896, UDI/DI case 40193489895897, Lot Number: 21HME198; Medline Kit Number/SKU DYNJ0753948J: UDI/DI each 10193489895896, UDI/DI case 40193489895897, Lot Number: 21FMD014; Medline Kit Number/SKU DYNJ0785741K: UDI/DI each 10193489603576, UDI/DI case 40193489603577, Lot Number: 21CKA430; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23JDA179; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23HDC666; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23FDB421; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23EDA191; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23CDC020; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23BDA963; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23ADB394; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23LDA280; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21ILA211; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21HLA920; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21HLA656; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21GLA243; Medline Kit Number/SKU DYNJ0991320M: UDI/DI each 10195327632458, UDI/DI case 40195327632459, Lot Number: 24IMH942; Medline Kit Number/SKU DYNJ0991320M: UDI/DI each 10195327632458, UDI/DI case 40195327632459, Lot Number: 24IMB140; Medline Kit Number/SKU DYNJ0991320M: UDI/DI each 10195327632458, UDI/DI case 40195327632459, Lot Number: 24GMB047; Medline Kit Number/SKU DYNJ0991320M: UDI/DI each 10195327632458, UDI/DI case 40195327632459, Lot Number: 24EMG280; Medline Kit Number/SKU DYNJ19521Q: UDI/DI each 10195327318079, UDI/DI case 40195327318070, Lot Number: 23BMB103; Medline Kit Number/SKU DYNJ19521Q: UDI/DI each 10195327318079, UDI/DI case 40195327318070, Lot Number: 25BMG556; Medline Kit Number/SKU DYNJ34623C: UDI/DI each 10889942745807, UDI/DI case 40889942745808, Lot Number: 23CBT880; Medline Kit Number/SKU DYNJ34623C: UDI/DI each 10889942745807, UDI/DI case 40889942745808, Lot Number: 22KBW690; Medline Kit Number/SKU DYNJ34623C: UDI/DI each 10889942745807, UDI/DI case 40889942745808, Lot Number: 21LBG909; Medline Kit Number/SKU DYNJ35305G: UDI/DI each 10195327070328, UDI/DI case 40195327070329, Lot Number: 23AMB303; Medline Kit Number/SKU DYNJ37547D: UDI/DI each 10889942945993, UDI/DI case 40889942945994, Lot Number: 21DDB912; Medline Kit Number/SKU DYNJ37547D: UDI/DI each 10889942945993, UDI/DI case 40889942945994, Lot Number: 21CDB910; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23JBY647; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23HBX192; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23GBC541; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23DBD185; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23CBP552; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23ABG640; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22JBW980; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22HBY401; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22GBG635; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22EBL969; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22CBX216; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22ABL872; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21KBK659; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21IBR941; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21FBG655; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21DBG029; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21CBJ871; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 26CBE134; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 26ABM247; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25KBF571; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25IBS828; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25HBF128; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25GBD444; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25EBN746; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25DBU598; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25BBP703; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24LBL146; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24HBR568; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24GBW861; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24FBL120; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24EBD749; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23LBI152; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23JMA313; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23HMH325; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23GMA570; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23EMI670; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23DMC678; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23CMB630; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22LMF935; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22HMF705; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22FMD171; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22FMD415; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22EMB584; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22DMF559; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 23DMH298; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 22KMH672; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 22GMD348; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 22FMD240; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/D...

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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