| | Class 2 Device Recall Medline Convenience Kits |  |
| Date Initiated by Firm | January 05, 2026 |
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| Date Posted | February 20, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1434-2026 |
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| Recall Event ID |
98319 |
| 510(K)Number | K112666 |
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| Product Classification |
Dressing change tray - Product Code OXQ
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| Product | Medline Convenience Kits:
1) NAIL KIT, Model Number: DYKM1528 |
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| Code Information |
1) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25BBO366;
2) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABI804;
3) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABF375;
4) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24JBL155;
5) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24IBG900;
6) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBT801;
7) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBC584;
8) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24DBB692;
9) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24BBL239;
10) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23KBO692;
11) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23IBT788;
12) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23HBJ026;
13) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23EBK780;
14) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23DBL149;
15) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23CBJ576 |
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 | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 1/6/26 was sent to customers regarding Saline Wound Wash.
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. Upon completion of the below actions, please destroy 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 response form.
Website link: https://recalls.medline.com
Recall Reference #: R-25-267
Recall Code:
3. Your account will receive credit once the response form is submitted.
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 request that customers destroy any affected product. You should include your customers quantities on your response form.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
An URGENT MEDICAL DEVICE RECALL notification letter dated 1/5/26 was sent to customers regarding Meijer Saline Wound Wash item number 347792.
REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.
2. Please complete and return the enclosed response form listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form.
3. Your account will receive credit once the response form is submitted, if applicable.
4. If you are a distributor, or have resold or transferred this prod |
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| Quantity in Commerce | 8773 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands. |
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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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| 510(K) Database | 510(K)s with Product Code = OXQ
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