| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | September 02, 2026 |
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| Date Posted | October 15, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0174-2027 |
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| Recall Event ID |
99886 |
| Product Classification |
laparoscopy kit - Product Code FDE
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| Product | Medline surgical convenience kits labeled as:
1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC;
2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AB;
3) CATH LAB ENDO AAA, Medline product number/SKU DYNJ35312I;
4) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AA. |
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| Code Information |
Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 25GME600;
Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 25DMJ601;
Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 25CMA596;
Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 24FMB407;
Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 24CMH524;
Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 23LMF661;
Medline product number/SKU DYNJ0656274AC, UDI/DI 10195327517311 (each) 40195327517312 (case), lot number 23JME256;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 23GMB142;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 23FMH674;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 23BMC121;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 23AMB446;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 22KMG366;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 22GMB609;
Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 22DDA108;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 22CME324;
Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 22CDB128;
Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 22BDA125;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 22AMG393;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21LMF161;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21LMB777;
Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 21JDC440;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21GME576;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21FMC491;
Medline product number/SKU DYNJ0656274AB, UDI/DI 10193489857900 (each) 40193489857901 (case), lot number 21CME380;
Medline product number/SKU DYNJ0656274AA, UDI/DI 10193489827095 (each) 40193489827096 (case), lot number 21BMD994;
Medline product number/SKU DYNJ35312I, UDI/DI 10193489481877 (each) 40193489481878 (case), lot number 21ADA403.
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| 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 |
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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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Quantity in Commerce | 472 kits |
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| Distribution | US Nationwide distribution. |
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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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