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

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

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-2016-2026
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
4016 kits
Made in
United States
Lot / code info
Medline 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 …
UPC codes
10195327334024, 40195327334025, 10198459374364, 40198459374365, 10193489800005, 40193489800006, 10195327196721, 40195327196722, 10195327587420, 40195327587421, 10195327050146, 40195327050147

Products covered by this recall

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.

Check your product

The notice names 52 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.

  • 10195327334024
  • 40195327334025
  • 10198459374364
  • 40198459374365
  • 10193489800005
  • 40193489800006
  • 10195327196721
  • 40195327196722
  • 10195327587420
  • 40195327587421
  • 10195327050146
  • 40195327050147

Lot or batch code

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

  • 23JLA668
  • 23JLA240
  • 25IMG470
  • 25GMI158
  • 25GMC404
  • 23ILA647
  • 23HLA953
  • 23GLA064
  • 23ELA715
  • 22KLB111
  • 22GLB222
  • 22ELA384
  • 22ELA314
  • 22CLA246
  • 22BLA951
  • 22ALB037
  • 21KLA949
  • 21KLA323
  • 21JLA776
  • 21ILA612

Model or item number

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

  • SKU CDS840402AI
  • CDS984890V
  • DYNJ0394874L
  • DYNJ0750993M
  • DYNJ0753933G
  • DYNJ0888159I
  • DYNJ39861C
  • DYNJ42626B
  • DYNJ45374F
  • DYNJ48949C
  • DYNJ54242B
  • DYNJ64188A
  • DYNJ69223
  • DYNJ81423C
  • DYNJ88249
  • DYNJ901203D
  • DYNJ904549F
  • DYNJ906303F
  • DYNJ906681C
  • DYNJ906681D

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 — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  3. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  4. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

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 10195327334024, 40195327334025, 10198459374364; lot code 23JLA668, 23JLA240, 25IMG470; model number SKU CDS840402AI, CDS984890V, DYNJ0394874L. 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?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

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