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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmJuly 08, 2026
Date PostedAugust 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2995-2026
Recall Event ID 99489
510(K)NumberK213481 
Product Classification General surgery tray - Product Code LRO
ProductMedline 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.
Code Information 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.
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley 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
ActionMedline 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 Commerce246 kits
DistributionUS 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 CycleTPLC 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.
510(K) Database510(K)s with Product Code = LRO
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