CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Medline medical convenience kits, labeled as: Neuro CDS, Medline Kit recalled

Medline Industries is recalling Medline medical convenience kits, labeled as: Neuro CDS, Medline Kit, distributed nationwide in the US. The recall was initiated on 8 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedline 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) 40193489863995 (case), Lot Number 23AMJ022; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23CMB364; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23EMD743; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23FMH669; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23JME474; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 22DMH314; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 22LME727; Medline Kit SKU DYNJ63477A, UDI/DI 10195327123451 (each) 40195327123452 (case), Lot Number 22EMB958; Medline Kit SKU DYNJ63477A, UDI/DI 10195327123451 (each) 40195327123452 (case), Lot Number 22EMC777; Medline Kit SKU DYNJ83071A, UDI/DI 10195327452490 (each) 40195327452491 (case), Lot Number 23HMF326.
Quantity recalled3468 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2996-2026
FDA event ID
99489
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
8 Jul 2026
FDA classified
21 Aug 2026
Reported
2 Sep 2026
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

8 Jul 2026Recall initiated by company
21 Aug 2026Classified by FDA+44 days
2 Sep 2026Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.

Nationwide ArizonaCaliforniaIowaIdahoIllinoisIndianaMassachusettsMarylandMichiganMinnesotaMissouriMontanaNew YorkOhioTexasWisconsinWyoming

Questions about this recall

Is Medline medical convenience kits, labeled as: Neuro CDS, Medline Kit recalled?

Yes. Medline Industries recalled Medline medical convenience kits, labeled as: Neuro CDS, Medline Kit on 8 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-2996-2026.

Why was it 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.

Which lots are affected?

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) 40193489863995 (case), Lot Number 23AMJ022; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23CMB364; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23EMD743; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23FMH669; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23JME474; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 22DMH314; Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 22LME727; Medline Kit SKU DYNJ63477A, UDI/DI 10195327123451 (each) 40195327123452 (case), Lot Number 22EMB958; Medline Kit SKU DYNJ63477A, UDI/DI 10195327123451 (each) 40195327123452 (case), Lot Number 22EMC777; Medline Kit SKU DYNJ83071A, UDI/DI 10195327452490 (each) 40195327452491 (case), Lot Number 23HMF326.

Where was it sold?

US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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