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

Medline medical convenience kits, labeled as recalled

Medline Industries is recalling Medline medical convenience kits, labeled as: Craniotomy Pack, 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 SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 25JMG396; Medline SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 26AMH848; Medline SKU Number DYNJ88056A, UDI 10198459372667 (each) 40198459372668 (case), Lot Number 25FMD894; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25JMH786; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF523; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF530; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 26CMD479; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABD437; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABO388; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23EBA762; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23HBG168; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23KBW672.

Quantity recalled246 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-2995-2026
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: Spinal Implants

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) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.

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 SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 25JMG396; Medline SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 26AMH848; Medline SKU Number DYNJ88056A, UDI 10198459372667 (each) 40198459372668 (case), Lot Number 25FMD894; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25JMH786; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF523; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF530; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 26CMD479; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABD437; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABO388; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23EBA762; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23HBG168; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23KBW672.

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

This product is part of a recall event; the main page for the event is Medline medical convenience kits, labeled as: Sinus Pack-lf recalled.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026	CLASS II	Medline medical convenience kits, labeled as: Sinus Pack-lf recalled	Medline Industries	Other	Nationwide
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

More recalls from Medline Industries

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Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS I	Medline Basic Homecare Beds and Medlite Homecare Beds recalled	Medline Industries	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS I	Medline Basic Homecare Beds and Medlite Homecare Beds recalled	Medline Industries	Other	Nationwide
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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