FDA Medical devices recall ·
Medline medical procedure kits, containing Medline Neuro Sponges (102 in… recall
- Recall number
- Z-2025-2026
- Date
- (initiated March 19, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 22116 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23KBN711; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23GBD593; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23GBD781; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23DBF906; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22LBI985; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22KBC504; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22IBF741; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22FBX069; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22DBS948; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22CBX667; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 21IBT137; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 21HBG608; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 25GBV215; Medline Kit Number/SKU CDS98037
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2025-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.