Class II Recall

Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline

Summary

The FDA issued a Class II for Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit S by Medline Industries, LP. Reason: Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to pote.

Details

Source

Device Recall

External ID

Z-2994-2026

Action Date

2026-09-02

Status

Ongoing

Product Description

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.

Lot/Code Info: 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.

Quantity Affected: 2262 kits

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.

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-07-08

Company

Medline Industries, LP

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 168 device recalls issued in the same week, part of 445 device-related FDA actions this month.

Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medline Industries, LP have FDA actions?

Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2994-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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