FDA Medical devices recall ·
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF… recall
- Recall number
- Z-2994-2026
- 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
- 2262 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; 12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I; 13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J; 14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K.
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 DYNJ0966146F, UDI/DI 10193489916379 (each) 40193489916370 (case), Lot Number 23HBC070; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 24CBA416; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23CBS214; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23FBC803; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23GBU042; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23IBO417; Medline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24EBH594; Medline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24FBQ494; Medline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24JBK316; Medline Kit SKU DYNJ44480D, UDI/DI 10198459241727 (each) 40198459241728 (case), Lot Number 25CDA135; Medline Kit SKU DYNJ58928A, UDI/DI 10193489763973 (each) 40193489763974 (case), Lot Number 23HBK833; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 24FBQ476; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 23EBI941; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 23HBX888; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Numb
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-2994-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.