Recall
FDAHealthMarch 19, 2026

Medline Industries, LP — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF

⚠️ 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.

Is this relevant to me?

Geography
Unknown
Source agency
FDA
Category
Health
Published
March 19, 2026

Worldwide distribution.

What's affected?

Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555C; 5. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555D.
Lot code
22EMB486

Additional details

Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22EMB486; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMI117; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMB218; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMB219; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21LMA406; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21LMA805; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21JMF667; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21IMF752; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21HMG136; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21HMB278; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21GMD367; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21CKA503; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21AKA471; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23JBT331; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23IBL993; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23GBN118; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23FBQ324; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23EBO916; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23CBI861; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23BBE825; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23ABD998; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22LBA177; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22IBJ001; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22FBY332; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22FBX502; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22EBE351; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22ABO417; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21WBA306; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21KBG927; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21GBW059; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21GBW057; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21EBP877; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21EBP891; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 26ABT067; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 25LBO620; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 25LBC010; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24KBR338; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24HBS302; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24HBR212; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24FBM377; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24EBC753; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24BBN421; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24BBG081; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23LBC938; Medline Kit Number/SKU DYNJ55555B: UDI/DI each 10195327040284, UDI/DI case 40195327040285, Lot Number: 22ABW137; Medline Kit Number/SKU DYNJ55555B: UDI/DI each 10195327040284, UDI/DI case 40195327040285, Lot Number: 22ABD653; Medline Kit Number/SKU DYNJ55555B: UDI/DI each 10195327040284, UDI/DI case 40195327040285, Lot Number: 21LBN774; Medline Kit Number/SKU DYNJ55555C: UDI/DI each 10195327154738, UDI/DI case 40195327154739, Lot Number: 22IBD321; Medline Kit Number/SKU DYNJ55555C: UDI/DI each 10195327154738, UDI/DI case 40195327154739, Lot Number: 22HBB560; Medline Kit Number/SKU DYNJ55555C: UDI/DI each 10195327154738, UDI/DI case 40195327154739, Lot Number: 22GBG766; Medline Kit Number/SKU DYNJ55555C: UDI/DI each 10195327154738, UDI/DI case 40195327154739, Lot Number: 22DBU479; Medline Kit Number/SKU DYNJ55555D: UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23KBQ339; Medline Kit Number/SKU DYNJ55555D: UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23JBF048; Medline Kit Number/SKU DYNJ55555D: UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23EBX527; Medline Kit Number/SKU DYNJ55555D: UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23DBG858; Medline Kit Number/SKU DYNJ55555D: UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23CBX731; Medline Kit Number/SKU DYNJ55555D: UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 23CBF699; Medline Kit Number/SKU DYNJ55555D: UDI/DI each 10195327276041, UDI/DI case 40195327276042, Lot Number: 22LBJ888.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 4324 kits.

View original FDA notice →

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