FDAFDA · Food and drugs·Recall number Z-2034-2026
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.
Published May 6, 2026 · Recall initiated: March 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- Worldwide distribution.
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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