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Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J; 5. NEURO BASIN KIT, Medline Kit Number/SKU DYNJ80200B; 6. NEURO-SPINE BASIN PACK, Medline Kit Number/SKU DYNJ83019; 7. ENT PACK, Medline Kit Number/SKU DYNJ86328; 8. EDMOND SPINE PACK, Medline Kit Number/SKU DYNJ89263; 9. ENT PACK, Medline Kit Number/SKU DYNJ89675; 10. ENT PACK, Medline Kit Number/SKU DYNJ89675A; 11. ENT/PAIN PACK, Medline Kit Number/SKU DYNJT7493.

Class II
Recalling firm
Medline Industries, LP
Reason for recall
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.
Affected products (lot / model / serial)
Medline Kit Number/SKU DYNJ0532910L: UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25IMD003; Medline Kit Number/SKU DYNJ0532910L: UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25HMH643; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22GBS127; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22FBB472; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25FBE752; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25EBA260; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25DBG176; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25CBD819; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25BBA593; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 24KBJ163; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23KMI415; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMK023; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMB211; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23IMC591; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23HMG291; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23GMG136; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23FME285; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23EME227; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23CMD903; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMI915; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMH419; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24JMG571; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24HMF066; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24FMG130; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24CMI441; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24BMD229; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24AMH016; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26BMB944; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26AMJ197; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25KMC587; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25JMD275; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25IMC944; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25GMF811; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25FME706; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 4019845921
Units affected
9805 kits
Distribution pattern
Worldwide distribution.
Firm location
Northfield, IL, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Devices
Status
Ongoing
Recall number
Z-2026-2026
Recall initiated
March 19, 2026
FDA classification date
April 30, 2026
FDA report date
May 6, 2026
FDA event ID
98664
Last updated on HTM Vibe
July 24, 2026
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