FDAClass IIMay 6, 2026

Medline medical procedure kits recall: Endotoxin

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.

Why was Medline medical procedure kits 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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.
Recalling firm
Medline Industries, LP
Quantity
4324 kits
Distribution
Worldwide distribution.
Recall date
May 6, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls