Class II U.S. Food and Drug Administration

Medline medical convenience kits, labeled as: 1) NEURO CDS recall: Specific item(s) and lot(s) of Medline convenience kits containing Pilling

Recall published last month

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

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-2996-2026
Published
September 2, 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
3468 kits
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit SKU CDS985246J, UDI/DI 10193489232394 (each) 40193489232395 (case), Lot Number 22HMB295; Medline Kit SKU CDS985246J, UDI/DI 10193489232394 (each) 40193489232395 (case), Lot Number 22IMB860; Medline Kit SKU DYNJ32770V, UDI/DI 10195327090111 (each) 40195327090112 (case), Lot Number 22FMB806; Medline Kit SKU DYNJ40095D, UDI/DI 10195327281250 (each) 40195327281251 (case), Lot Number 23GMI744; Medline Kit SKU DYNJ42844D, UDI/DI 10193489880564 (each) 40193489880565 (case), Lot Number 25EBV362; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25CMH980; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25FMB096; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25GMA066; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25GMH940; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25BMI081; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25IMC735; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24DME519; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24EMG256; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24GMJ491; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24IMA243; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24JMA162; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24JMD784; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24KMI470; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24ABN077; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24ABN475; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24DBA116; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23AMH395; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23EMA407; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23HBH164; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23HBO192; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23HBV863; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23IBF802; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23IBS028; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23JBV613; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22BME230; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22CMA406; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22EMB248; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22EMI134; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22HME564; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22IMA455; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22JMI068; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22LMB601; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 24BMI624; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 24EME751; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 401…
UPC codes
10193489232394, 40193489232395, 10195327090111, 40195327090112, 10195327281250, 40195327281251, 10193489880564, 40193489880565, 10193489887631, 40193489887632, 10193489863994, 40193489863995

Products covered by this recall

Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D; 5) NEURO PACK, Medline Kit SKU DYNJ45121I; 6) NEURO LAMINECTOMY PACK, Medline Kit SKU DYNJ58012A; 7) NEURO PACK SJ, Medline Kit SKU DYNJ63477A; 8) BASIC NEURO PACK, Medline Kit SKU DYNJ83071A.

Check your product

The notice names 47 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.

  • 10193489232394
  • 40193489232395
  • 10195327090111
  • 40195327090112
  • 10195327281250
  • 40195327281251
  • 10193489880564
  • 40193489880565
  • 10193489887631
  • 40193489887632
  • 10193489863994
  • 40193489863995

Lot or batch code

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

  • 22HMB295
  • 22IMB860
  • 22FMB806
  • 23GMI744
  • 25EBV362
  • 25CMH980
  • 25FMB096
  • 25GMA066
  • 25GMH940
  • 25BMI081
  • 25IMC735
  • 24DME519
  • 24EMG256
  • 24GMJ491
  • 24IMA243
  • 24JMA162
  • 24JMD784
  • 24KMI470
  • 24ABN077
  • 24ABN475

Model or item number

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

  • CDS985246J
  • DYNJ32770V
  • DYNJ40095D
  • DYNJ42844D
  • DYNJ45121I
  • DYNJ58012A
  • DYNJ63477A
  • UDI
  • DI 10
  • DI 10193489232394
  • DI 10195327090111
  • DI 10195327281250
  • DI 10193489880564
  • DI 10193489887631
  • DI 10193489863994

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 — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  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.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

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?

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges. Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10193489232394, 40193489232395, 10195327090111; lot code 22HMB295, 22IMB860, 22FMB806; model number CDS985246J, DYNJ32770V, DYNJ40095D. 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?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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