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Class 2 Device Recall Medline

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Class 2 Device Recall Medline

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Date Initiated by Firm	July 08, 2026
Date Posted	August 21, 2026
Recall Status¹	Open³, Classified
Recall Number	Z-2994-2026
Recall Event ID	99489
Product Classification	Ear, nose, and throat surgical tray - Product Code OGR
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.
Code Information	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 Number 22KBR883; Medline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25JMC017; Medline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25KMB183; Medline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25AMG343; Medline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25DMJ252; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 23ABM594; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 23DBQ757; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 23EBL559; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22FBC585; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22GBO880; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22HBN179; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22HBU967; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 25CME312; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 25FME826; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 24IMA157; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 24IMF249; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23EBI617; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23GBJ097; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23HBS862; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23JBU735; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23KBI060; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23ABS340; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23ABS768; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23BBB045; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23HBP969; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 22HBR343; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 22HBT245; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 22LBL269; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24DBD707; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24DBD912; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24HBR037; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24IBF556; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24JBM973; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 23LBG405; Medline Kit SKU DYNJ903679I, UDI/DI 10198459225758 (each) 40198459225759 (case), Lot Number 25BBD293; Medline Kit SKU DYNJ903679I, UDI/DI 10198459225758 (each) 40198459225759 (case), Lot Number 25BBF473; Medline Kit SKU DYNJ903679I, UDI/DI 10198459225758 (each) 40198459225759 (case), Lot Number 25BBF871; Medline Kit SKU DYNJ903679J, UDI/DI 10198459313035 (each) 40198459313036 (case), Lot Number 25DBU804; Medline Kit SKU DYNJ903679J, UDI/DI 10198459313035 (each) 40198459313036 (case), Lot Number 25EBN687; Medline Kit SKU DYNJ903679J, UDI/DI 10198459313035 (each) 40198459313036 (case), Lot Number 25FBR466; Medline Kit SKU DYNJ903679K, UDI/DI 10198459399916 (each) 40198459399917 (case), Lot Number 25HBF447; Medline Kit SKU DYNJ903679K, UDI/DI 10198459399916 (each) 40198459399917 (case), Lot Number 25KBT345.
FEI Number	1417592
Recalling Firm/ Manufacturer	Medline Industries, LP 3 Lakes Dr Northfield IL 60093-2753
For Additional Information Contact	Haley Barclay 800-359-1704
Manufacturer 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 ²	Nonconforming Material/Component
Action	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.
Quantity in Commerce	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.
Total Product Life Cycle	TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. ² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. ³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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