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FDAFDA recall Z-2995-2026 · Sep 2, 2026

Medline Industries, LP: Medline medical convenience kits recall

Recall found

Product

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.

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification
Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status
Ongoing
Codes, lots and dates
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.
Quantity
246 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
Voluntary or mandated
Voluntary: Firm initiated
Recall started
2026-07-08

Source: openFDA enforcement record Z-2995-2026 · search recall number Z-2995-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.

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