| | Class 2 Device Recall Medline Convenience Kits |  |
| Date Initiated by Firm | January 07, 2026 |
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| Date Posted | February 17, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1392-2026 |
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| Recall Event ID |
98329 |
| Product Classification |
CT biopsy tray - Product Code OFG
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| Product | Medline Convenience Kits:
1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A;
2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A;
3) CT BIOPSY TRAY, Model Number: DYNDH1143C;
4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873;
5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934;
6) BREAST BIOPSY PACK, Model Number: DYNJ17489I;
7) VOR PACK-LF, Model Number: DYNJ48539;
8) VOR PACK-LF, Model Number: DYNJ48539A;
9) IR BIOPSY PACK, Model Number: DYNJ59897B;
10) BREAST PACK, Model Number: DYNJ82998 |
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| Code Information |
1) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 23ABK216;
2) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBU924;
3) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBQ267;
4) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBL439;
5) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBC364;
6) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23ABU170;
7) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBM302;
8) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBK913;
9) DYNDH1143C, UDI-DI: 10193489193336(each), 40193489193337(case), Lot Number: 22GBZ268;
10) DYNDH1873, UDI-DI: 10195327486464(each), 40195327486465(case), Lot Number: 23KBK476;
11) DYNDH1934, UDI-DI: 10195327519728(each), 40195327519729(case), Lot Number: 24FMF173;
12) DYNJ17489I, UDI-DI: 10195327224783(each), 40195327224784(case), Lot Number: 23CBL337;
13) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24GBD309;
14) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24EBQ366;
15) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24DBK656;
16) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24ABL751;
17) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23KBD033;
18) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23HBR688;
19) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23GBI270;
20) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23DMD933;
21) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23AMC919;
22) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22EMD675;
23) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22BMH767;
24) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 21JMC430;
25) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LMF497;
26) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LME482;
27) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25JBA908;
28) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25IBA545;
29) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25HBK043;
30) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25EBA588;
31) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 24IBT900;
32) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23EBQ760;
33) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 22LBH614;
34) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22LMF004;
35) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22JMG410 |
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 issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled 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 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes.
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-26-003
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 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes.
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-26-003-FGX1
Recall Code:
3. Upon receipt of your submitted response form, |
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| Quantity in Commerce | 2740 units |
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| Distribution | Worldwide distribution - US Nationwide. |
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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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