| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | July 08, 2026 |
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| Date Posted | August 21, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2996-2026 |
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| Recall Event ID |
99489 |
| Product Classification |
Neurological tray - Product Code OJG
|
| Product | Medline medical convenience kits, labeled as:
1) NEURO CDS, Medline Kit SKU CDS985246J;
2) NEURO PACK, Medline Kit SKU DYNJ32770V;
3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D;
4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D;
5) NEURO PACK, Medline Kit SKU DYNJ45121I;
6) NEURO LAMINECTOMY PACK, Medline Kit SKU DYNJ58012A;
7) NEURO PACK SJ, Medline Kit SKU DYNJ63477A;
8) BASIC NEURO PACK, Medline Kit SKU DYNJ83071A. |
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| Code Information |
Medline Kit SKU CDS985246J, UDI/DI 10193489232394 (each) 40193489232395 (case), Lot Number 22HMB295;
Medline Kit SKU CDS985246J, UDI/DI 10193489232394 (each) 40193489232395 (case), Lot Number 22IMB860;
Medline Kit SKU DYNJ32770V, UDI/DI 10195327090111 (each) 40195327090112 (case), Lot Number 22FMB806;
Medline Kit SKU DYNJ40095D, UDI/DI 10195327281250 (each) 40195327281251 (case), Lot Number 23GMI744;
Medline Kit SKU DYNJ42844D, UDI/DI 10193489880564 (each) 40193489880565 (case), Lot Number 25EBV362;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25CMH980;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25FMB096;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25GMA066;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25GMH940;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25BMI081;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 25IMC735;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24DME519;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24EMG256;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24GMJ491;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24IMA243;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24JMA162;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24JMD784;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24KMI470;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24ABN077;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24ABN475;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 24DBA116;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23AMH395;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23EMA407;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23HBH164;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23HBO192;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23HBV863;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23IBF802;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23IBS028;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 23JBV613;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22BME230;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22CMA406;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22EMB248;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22EMI134;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22HME564;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22IMA455;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22JMI068;
Medline Kit SKU DYNJ45121I, UDI/DI 10193489887631 (each) 40193489887632 (case), Lot Number 22LMB601;
Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 24BMI624;
Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 24EME751;
Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23AMJ022;
Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23CMB364;
Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23EMD743;
Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23FMH669;
Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 23JME474;
Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 22DMH314;
Medline Kit SKU DYNJ58012A, UDI/DI 10193489863994 (each) 40193489863995 (case), Lot Number 22LME727;
Medline Kit SKU DYNJ63477A, UDI/DI 10195327123451 (each) 40195327123452 (case), Lot Number 22EMB958;
Medline Kit SKU DYNJ63477A, UDI/DI 10195327123451 (each) 40195327123452 (case), Lot Number 22EMC777;
Medline Kit SKU DYNJ83071A, UDI/DI 10195327452490 (each) 40195327452491 (case), Lot Number 23HMF326. |
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
800-359-1704 |
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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. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | Medline 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. |
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| Quantity in Commerce | 3468 kits |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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