CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Medline medical convenience kits, labeled as: Sinus Pack-lf recalled

Medline Industries is recalling Medline medical convenience kits, labeled as: Sinus Pack-lf, Medline Kit, distributed nationwide in the US. The recall was initiated on 8 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedline 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 recalled2262 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2994-2026
FDA event ID: 99489
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jul 2026
FDA classified: 21 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Jul 2026	Recall initiated by company
21 Aug 2026	Classified by FDA	+44 days
2 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.

Nationwide Arizona California Iowa Idaho Illinois Indiana Massachusetts Maryland Michigan Minnesota Missouri Montana New York Ohio Texas Wisconsin Wyoming

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 99489

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026	CLASS II	Medline medical convenience kits, labeled as: Neuro CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide

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30 Sep 2026Device	CLASS II	Medline Convenience Kits: Major Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide

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