Z-2028-2026 Class II Ongoing
FDA device recall Z-2028-2026 was initiated by Medline Industries, LP on March 19, 2026 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 3000 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- March 19, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3000 kits
Product Description
Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
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.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI EACH 10653160323068, UDI/DI case 40653160323069. Lot Numbers: 23JBY390, 23IBS518, 23FBW067, 23CBO045, 22HBC645, 22GBL079, 22DBP674, 22ABU694, 21IBM298, 21IBM495, 21GBB532, 21EBR576, 21CBL756, 21ABI942, 26ABG606, 25LBS129, 25IBK286, 25GBB222, 25DBH934, 25BBD132, 24LBO080, 24JBW176, 24HBT740, 24EBU727, 24ABW463.