| | Class 1 Device Recall MEDLINE medical procedure convenience kit |  |
| Date Initiated by Firm | June 08, 2026 |
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| Date Posted | July 23, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2765-2026 |
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| Recall Event ID |
99297 |
| Product Classification |
Orthopedic tray - Product Code OJH
|
| Product | MEDLINE medical procedure convenience kit labeled as:
1) LISTON TOTAL KNEE-LF, Medline kit SKU CDSOPT590T;
2) LISTON TOTAL KNEE-LF, Medline kit SKU CDSOPT590U;
3) TOTAL KNEE CDS, Medline kit SKU CDS983930J;
4) LISTON HIP CDS-LF, Medline kit SKU CDS984556L;
5) LISTON HIP CDS-LF, Medline kit SKU CDS984556M;
6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q. |
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| Code Information |
Medline kit SKU CDSOPT590T, UDI/DI 10195327555009 (each) 40195327555000 (case), Kit Lot Number 24GDA740;
Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 26EDA279;
Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 26BDB734;
Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 26ADA474;
Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25LDA001;
Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25KDB325;
Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25GDB517;
Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25FDB017;
Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 25DDA155;
Medline kit SKU CDSOPT590U, UDI/DI 10198459180255 (each) 40198459180256 (case), Kit Lot Number 24LDA248;
Medline kit SKU CDS983930J, UDI/DI 10193489512298 (each) 40193489512299 (case), Kit Lot Number 25KBL209;
Medline kit SKU CDS984556L, UDI/DI 10195327554996 (each) 40195327554997 (case), Kit Lot Number 24JDC180;
Medline kit SKU CDS984556L, UDI/DI 10195327554996 (each) 40195327554997 (case), Kit Lot Number 24HDA321;
Medline kit SKU CDS984556M, UDI/DI 10198459180248 (each) 40198459180249 (case), Kit Lot Number 25ADB327;
Medline kit SKU DYNJ905162Q, UDI/DI 10198459235900 (each) 40198459235901 (case), Kit Lot Number 26CBD346;
Medline kit SKU DYNJ905162Q, UDI/DI 10198459235900 (each) 40198459235901 (case), Kit Lot Number 25KBU219. |
| 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 | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing ICU Medical, Inc. pain management kits with Bupivacaine Hydrochloride in Dextrose Injection, USP. ICU Medical, Inc. has been made aware of an urgent medical device recall initiated by Elevaris Medical Devices Inc. for Bupivacaine Hydrochloride in Dextrose Injection ampules due to quality issues, which could result in drug ineffectiveness. |
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FDA Determined
Cause 2 | Other |
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| Action | Medline Industries, LP issued an URGENT MEDICAL DEVCIE RECALL notice to its consignees on 6/8/2026 via email and USPS first class mail. The notice explained the issue and requested the following actions be taken:
1. Check stock and quarantine all affected product.
2. Use Website link: https://recalls.medline.com to respond.
3. Once response is received, Medline will send over-labels to affix to affected inventory (if applicable).
4. If the consignee further distributed or transferred the affected product, those to whom the product was sent are to be notified.
For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 318 kits |
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| Distribution | US: Mo, CO, IL |
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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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