FDAFDA · Food and drugs·Recall number Z-2035-2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
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 DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21KBM212; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21IBT678; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21GBF973; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21EBR775; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21DBH715; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21BBI962; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22HBO534; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22FBY086; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22FBG752; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22CBY116; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22ABS155; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 21LBF114; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23JBN926; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23FBE547; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23EBI633; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23DBA946; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23CBD209; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23ABH377.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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