FDA Medical devices recall ·
Medline medical convenience kits, labeled as: 1) NEURO CDS… recall
- Recall number
- Z-2996-2026
- Date
- (initiated July 8, 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
- 3468 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D; 5) NEURO PACK, Medline Kit SKU DYNJ45121I; 6) NEURO LAMINECTOMY PACK, Medline Kit SKU DYNJ58012A; 7) NEURO PACK SJ, Medline Kit SKU DYNJ63477A; 8) BASIC NEURO PACK, Medline Kit SKU DYNJ83071A.
Why was it recalled?
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
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 SKU CDS985246J, UDI/DI 10193489232394 (each) 40193489232395 (case), Lot Number 22HMB295; Medline Kit SKU CDS985246J, UDI/DI 10193489232394 (each) 40193489232395 (case), Lot Number 22IMB860; Medline Kit SKU DYNJ32770V, UDI/DI 10195327090111 (each) 40195327090112 (case), Lot Number 22FMB806; Medline Kit SKU DYNJ40095D, UDI/DI 10195327281250 (each) 40195327281251 (case), Lot Number 23GMI744; Medline Kit SKU DYNJ42844D, UDI/DI 10193489880564 (each) 40193489880565 (case), Lot Number 25EBV362; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25CMH980; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25FMB096; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25GMA066; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25GMH940; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25BMI081; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25IMC735; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24DME519; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24EMG256; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24GMJ491; Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Nu
Distribution
US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
States: Arizona California Iowa Idaho Illinois Indiana Massachusetts Maryland Michigan Minnesota Missouri Montana New York Ohio Texas Wisconsin Wyoming
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-2996-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.