| | Class 2 Device Recall MEDLINE |  |
| Date Initiated by Firm | May 04, 2026 |
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| Date Posted | June 17, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2496-2026 |
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| Recall Event ID |
98994 |
| Product Classification |
Kit, surgical instrument, disposable - Product Code KDD
|
| Product | MEDLINE Medical Procedure Kits labeled as:
1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A;
2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B;
3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C;
4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414;
5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G;
6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F;
7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G. |
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| Code Information |
Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887, (each) 40195327191888, (case), Lot Number 22HMA818;
Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887, (each) 40195327191888, (case), Lot Number 22GMG188;
Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23FMB021;
Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23CMB395;
Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23BMF105;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 25BMG115;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KMG981;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KMG043;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KME988;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24JMC883;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24HMG291;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24GMG957;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24GMC708;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24EMD960;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24EMD976;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24CMC199;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23LMH271;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23LMC861;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23JMI184;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23JMC583;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23IMH859;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23HME147;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23HMB823;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23GMD479;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23FMH321;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23FME722;
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24EMC843;
Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 26CME546;
Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 26AMD910;
Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25KMF065;
Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25IMI592;
Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25HMB017A;
Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25HMB017;
Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25GMK081;
Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25DMI874;
Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25BME130;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 24CBE682;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23LBN771;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23LBJ194;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23KBO599;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23FBO284;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23EBM695;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22IBP839;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22GBU984;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22EBB509;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22DBE259;
Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22CBX946;
Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 25CMI392;
Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 24LMA643;
Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 24EMD913;
Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 23GMB073;
Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 23FMF264;
Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 23EMA833;
Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 24CMA172;
Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 23LMB006;
Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 23KMF820;
Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 23FMA119;
Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 23AMG228;
Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 22HMB147;
Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 22BMH157. |
| 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 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers.
For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 1432 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI. |
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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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