| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | December 16, 2025 |
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| Date Posted | January 14, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1087-2026 |
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| Recall Event ID |
98197 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | Medline medical procedure convenience kits labeled as:
1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF;
2) ROBOTIC PROCEDURE, REF CDS982128Q;
3) CUH THORACIC, REF CDS984338M;
4) THORACIC PROCEDURE, REF CDS984640I;
5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O;
6) LAP CHOLE PACK, REF DYNJ57640F;
7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D;
8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D;
9) LAPAROSCOPY PACK, REF DYNJ68187B;
10) LAPAROSCOPY PACK, REF DYNJ82368A;
11) ROBOTIC KIDNEY PACK, REF DYNJ85261;
12) DOWNTOWN ROBOTICS, REF DYNJ86178B;
13) DAVINCI LITHOTOMY PACK, REF DYNJ87610;
14) ROBOTIC WHIPPLE PACK, REF DYNJ88433;
15) PROSTATE DAVINCI, REF DYNJ900127G;
16) GENERAL LAPAROSCOPY, REF DYNJ901847M;
17) LAG TLH, REF DYNJ901890N;
18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S;
19) LAP, REF DYNJ904576B;
20) ROBOTIC, REF DYNJ905147B;
21) ROBOTICS GYN, REF DYNJ905824M;
22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B;
23) CHN OR BASIC ROBOTIC, REF DYNJ905982I;
24) KIT ROBOTIC RFD, REF DYNJ906311F;
25) ROBOTIC PROSTATE, REF DYNJ906381G;
26) DAVINCI, REF DYNJ907392C;
27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C;
28) GYN, REF DYNJ908504B;
29) UROLOGY ROBOTIC, REF DYNJ908588I;
30) THORACIC ROBOTICS, REF DYNJ908777A;
31) GENERAL ROBOT, REF DYNJ908969A;
32) KIT ROBOTIC, REF DYNJ909870B;
33) ROBOTIC THORACOSCOPY, REF DYNJ910924. |
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| Code Information |
REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25FBK870;
REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25EBD110;
REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25EBC253;
REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25DBG393;
REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25FBQ303;
REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25EBD631;
REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25DBM322;
REF CDS984640I: UDI/DI 10198459318955 (EA) 40198459318956 (CS), Lot Number 25DBT807;
REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25DMG099;
REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25CMJ006;
REF DYNJ57640F: UDI/DI 10198459011115 (EA) 40198459011116 (CS), Lot Number 25FDB347;
REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25EBK539;
REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25DBD145;
REF DYNJ63392D: UDI/DI 10198459164507 (EA) 40198459164508 (CS), Lot Number 25BLA967;
REF DYNJ68187B: UDI/DI 10198459382086 (EA) 40198459382087 (CS), Lot Number 25FMG440;
REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25EMH020;
REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25CMF917;
REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25FBK331;
REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25EBR783;
REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBP320;
REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBC981;
REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25DBA834;
REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25CBM884;
REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25FBK123;
REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25EBF929;
REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25CBT135;
REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25FMC215;
REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMF199;
REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMC621;
REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25FBO994;
REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25EBE439;
REF DYNJ901847M: UDI/DI 10198459037863 (EA) 40198459037864 (CS), Lot Number 25BBM364;
REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25FBJ408;
REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25EBJ877;
REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBO236;
REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBC133;
REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMH506;
REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMD329;
REF DYNJ905147B: UDI/DI 10193489569032 (EA) 40193489569033 (CS), Lot Number 25GDB060;
REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25DMK337;
REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25CMF465;
REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25EBG945;
REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25CBM218;
REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25EMD118;
REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25DMJ823;
REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMJ265;
REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC374;
REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC546;
REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25EBI860;
REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25DBR934;
REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25CBF096;
REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBJ655;
REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBE873;
REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25EBB258;
REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25DBR935;
REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25DMH137;
REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25CMJ730;
REF DYNJ907405C: UDI/DI 10195327541392 (EA) 40195327541393 (CS), Lot Number 25CMF429;
REF DYNJ908504B: UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25FBG752;
REF DYNJ908504B: UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25DBS537;
REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25FDA930;
REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDB953;
REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDA576;
REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25DDA437;
REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25CDB060;
REF DYNJ908777A: UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577;
REF DYNJ908777A: UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577Z;
REF DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25EBI127;
REF DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBP413;
REF DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBD522;
REF DYNJ909870B: UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25EBF813;
REF DYNJ909870B: UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25DBD407;
REF DYNJ910924: UDI/DI 10198459203442 (EA) 40198459203443 (CS), Lot Number 25EBK656. |
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
800-359-1704 |
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Manufacturer Reason
for Recall | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/16/2025 via email and USPS first class mail. The notice explained the issue, potential risk, and requested the following:
"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 quantityof affected product you have in inventory on the form. Even if you do not have any affected productin inventory, please complete and submit the form.
Website link: https://recalls.medline.comRecall Reference #: R-25-145-FGX5
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 | 4536 units |
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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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