Z-2996-2026Class II

Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK...

Name: Z-2996-2026 Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK...
Creator: Medline Industries, LP
Published: 2026-07-08
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-07-08 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of 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... on 2026-07-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2996-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-08
Posted: 2026-08-21
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: OJG Neurological Tray
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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 [email protected].
Quantity in commerce: 3468 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2996-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2994-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-2995-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-2996-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-2997-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21

Product code OJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)