| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | September 02, 2026 |
|---|
| Date Posted | October 15, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0177-2027 |
|---|
| Recall Event ID |
99886 |
| Product Classification |
Neurological tray - Product Code OJG
|
| Product | Medline surgical convenience kits labeled as:
1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A;
2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M. |
|---|
| Code Information |
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 26BBC545;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 26ABM193;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25LBD334;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25JBL305;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25IBF209;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25HBI041;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25FBF808;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25EBO692;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25DBG912;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25BBS302;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25ABN459;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24LBQ417;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24KBL387;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24KBB074;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24IBI827;
Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24HBL301;
Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 22CLA280;
Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 22ALA687;
Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21KLA284;
Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21JLA298;
Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21HLA613;
Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21GLA706;
Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21DLA076;
Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21ALA482;
Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 20LLA600.
|
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield
IL
60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
|---|
Manufacturer Reason
for Recall | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 9/2/2026 via USPS first class mail and email. The notice explained the issue, potential risk, 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-26-201-FG, 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."
Those consignees who further distributed the product were directed to notify the parties to whom the affected product was distributed.
For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
|---|
| Quantity in Commerce | 1900 kits |
|---|
| Distribution | US Nationwide distribution. |
|---|
| Total Product Life Cycle | TPLC 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.
|
|
|
|
