| | Class 2 Device Recall Medline Convenience Kits |  |
| Date Initiated by Firm | May 21, 2026 |
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| Date Posted | June 29, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2542-2026 |
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| Recall Event ID |
99162 |
| Product Classification |
Tray, surgical - Product Code LRP
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| Product | Medline Convenience Kits:
1) SUTURE TRAY, Model Number: SUT12260;
2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390;
3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715;
4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351;
5) MYELOGRAM PACK, Model Number: P155615A;
6) CHEST TUBE INSERTION TRAY, Model Number: MNS3390;
7) LACERATION TRAY, Model Number: SUT18660A;
8) GENERAL BIOPSY TRAY, Model Number: MNS5985;
9) LACERATION TRAY, Model Number: DYNDL1351;
10) 20GX3" RADIAL ART LINE KIT, Model Number: ART351;
11) ARTERIAL LINE TRAY, Model Number: ART600;
12) SUTURE TRAY, Model Number: SUT12260;
13) ER SUTURING TRAY, Model Number: SUT9710C;
14) INCISION & DRAINAGE TRAY, Model Number: ID2060;
15) LACERATION TRAY - SNAG FREE, Model Number: SUT12265;
16) BIOPSY TRAY, Model Number: DYNDH1466;
17) GENERAL BIOPSY TRAY, Model Number: MNS5985;
18) SUTURE SET, Model Number: SUT19665;
19) MYELOGRAM-LF SAFE PACK, Model Number: P124863;
20) 20GX3" RADIAL ART LINE KIT, Model Number: ART351;
21) LACERATION TRAY, Model Number: SUT18660A;
22) 20GX6" FEMORAL ART LINE KIT, Model Number: ART352;
23) BIOPSY PACK, Model Number: DYNDH1699;
24) SUTURE TRAY, Model Number: SUT12260;
25) CHEST TUBE INSERTION TRAY, Model Number: MNS3390;
26) ARTHROGRAM TRAY, Model Number: SPEC0070B;
27) SUTURING SET, Model Number: SUT4155;
28) SUTURE TRAY, Model Number: SUT16080;
30) MYELOGRAM TRAY CHOICE, Model Number: DYNDH1213;
31) MYELOGRAM PACK, Model Number: P155615A;
32) LACERATION TRAY - SNAG FREE, Model Number: SUT12265 |
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| Code Information |
1) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2026031190;
2) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025120590;
3) MNS9715, UDI-DI: 10653160292029(each), 00653160292022(case), Lot Number: 2025120890;
4) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025120990;
5) P155615A, UDI-DI: 10889942219889(each), 40889942219880(case), Lot Number: 2025120890;
6) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025102790;
7) SUT18660A, UDI-DI: 10653160359302(each), 00653160359305(case), Lot Number: 2025120890;
8) MNS5985, UDI-DI: 00653160204407(each), 10653160204404(case), Lot Number: 2025120590;
9) DYNDL1351, UDI-DI: 10884389278352(each), 40884389278353(case), Lot Number: 2025120190;
10) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025112690;
11) ART600, UDI-DI: 10653160312727(each), 00653160312720(case), Lot Number: 2025112690;
12) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2025112690;
13) SUT9710C, UDI-DI: 10653160331254(each), 00653160331257(case), Lot Number: 2025103090;
14) ID2060, UDI-DI: 10653160310006(each), 00653160310009(case), Lot Number: 2025101790;
15) SUT12265, UDI-DI: 00653160130898(each), 10653160130895(case), Lot Number: 2025102390;
16) DYNDH1466, UDI-DI: 10193489193756(each), 20193489193753(case), Lot Number: 2025102190;
17) MNS5985, UDI-DI: 00653160204407(each), 10653160204404(case), Lot Number: 2025101690;
18) SUT19665, UDI-DI: 10653160288572(each), 00653160288575(case), Lot Number: 2025102490;
19) P124863, UDI-DI: 10889942140787(each), 40889942140788(case), Lot Number: 2025102090;
20) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025101090;
21) SUT18660A, UDI-DI: 10653160359302(each), 00653160359305(case), Lot Number: 2025092690;
22) ART352, UDI-DI: 10653160323747(each), 00653160323740(case), Lot Number: 2025100790;
23) DYNDH1699, UDI-DI: 10653160349914(each), 00653160349917(case), Lot Number: 2025092590;
24) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2025092690;
25) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025091590;
26) SPEC0070B, UDI-DI: 10193489196627(each), 20193489196624(case), Lot Number: 2025100890;
27) SUT4155, UDI-DI: 00653160008760(each), 50653160008765(case), Lot Number: 2025100990;
28) SUT16080, UDI-DI: 00653160225051(each), 10653160225058(case), Lot Number: 2025092690;
29) DYNDH1213, UDI-DI: 10653160383864(each), 00653160383867(case), Lot Number: 2025091990;
30) P155615A, UDI-DI: 10889942219889(each), 40889942219880(case), Lot Number: 2025090490;
31) SUT12265, UDI-DI: 00653160130898(each), 10653160130895(case), Lot Number: 2025090590 |
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 5/21/26 was sent to customers.
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-26-082-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.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 15662 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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