Recall Z-2034-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-03-19. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-19
- Firm location
- Northfield, IL, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.