Class II U.S. Food and Drug Administration

Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin

Recall published 6 months ago

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.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2022-2026
Published
May 6, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
21288 kits
Made in
United States
Lot / code info
Medline 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 …
UPC codes
10198459000218, 40198459000219, 10195327119478, 40195327119479, 10195327371319, 40195327371310, 10198459311321, 40198459311322, 10195327587260, 40195327587261, 10193489895896, 40193489895897, 10193489603576, 40193489603577, 10195327286460, 40195327286461

Products covered by this recall

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, Medline Kit Number/SKU DYNJ902985F; 52. KIT FREE FLAP MOSES, Medline Kit Number/SKU DYNJ905366B; 53. FLAP, Medline Kit Number/SKU DYNJ907076C; 54. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165; 55. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165A; 56. ENDOSCOPY, Medline Kit Number/SKU DYNJ909512; 57. DIEP FLAP, Medline Kit Number/SKU DYNJ910120A; 58. DIEP BREAST, Medline Kit Number/SKU DYNJ911086; 59. WILLIAMS GENERAL, Medline Kit Number/SKU DYNJ940735F; 60. ROBOTIC LAP PROSTATE PACK CHS, Medline Kit Number/SKU DYNJT3101; 61. CUH FLAP ACCESSORY PACK, Medline Kit Number/SKU DYNJT3243.

Check your product

The notice names 56 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10198459000218
  • 40198459000219
  • 10195327119478
  • 40195327119479
  • 10195327371319
  • 40195327371310
  • 10198459311321
  • 40198459311322
  • 10195327587260
  • 40195327587261
  • 10193489895896
  • 40193489895897
  • 10193489603576
  • 40193489603577
  • 10195327286460
  • 40195327286461

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25EDA675
  • 25CDA718
  • 25BDA328
  • 24KDB408
  • 24KDA607
  • 23HMH658
  • 23GMD341
  • 23EMB793
  • 23CMG372
  • 23BMI499
  • 22JMF967
  • 22EMC648
  • 22CMD889
  • 24EMH897
  • 24DMF264
  • 24BMJ904
  • 24AMH650
  • 23IME074
  • 23IMA416
  • 23EME302

Model or item number

On the rating label, the box or the instruction sheet.

  • CDS983493N
  • DYNJ02476O
  • DYNJ0426069N
  • DYNJ0426069Q
  • DYNJ0429303L
  • LL BASE PACK-LF
  • SKU DYNJ0753948
  • DYNJ0785741K
  • DYNJ0843063K
  • DYNJ0991320K
  • DYNJ0991320M
  • DYNJ19521Q
  • DYNJ34623C
  • DYNJ35305G
  • DYNJ37547D
  • DYNJ40406A
  • DYNJ40645C
  • DYNJ40648G
  • DYNJ50808A
  • DYNJ52062

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Medline Industries, LP — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459000218, 40198459000219, 10195327119478; lot code 25EDA675, 25CDA718, 25BDA328; model number CDS983493N, DYNJ02476O, DYNJ0426069N. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

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