Recall Z-2994-2026

Medline Industries, LP · initiated July 8, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: 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…

Reason for recall

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.

FDA-determined cause: Nonconforming Material/Component

Action taken

Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/8/2026 via USPS and email. The notice explained the issue, potential adverse health consequences, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-112-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Details

Recall number
Z-2994-2026
Initiated
July 8, 2026
Posted by FDA
August 21, 2026
Product code
OGR – Ear, Nose, And Throat Surgical Tray
Quantity
2262 kits
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.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2995-2026 Class IIMedline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and… 07/08/2026Open, Classified
Z-2996-2026 Class IIMedline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and… 07/08/2026Open, Classified
Z-2997-2026 Class IIMedline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and… 07/08/2026Open, Classified