MEDLINE medical procedure convenience kit labeled as recallZ-2765-2026 · Medline Industries, LP · initiated Jun 8, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-2765-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2026
- Posted by the FDA
- Jul 23, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 318 kits
- Product code
- OJH
- Distribution
- US: Mo, CO, IL
Product description
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS984556M; 6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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.
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. CDS983930JMedline Industries, Inc. · Orthopedic tray1 recall0 reports
- Medline Industries, Inc. CDS984556LMedline Industries, Inc. · Orthopedic tray1 recall0 reports
- Medline Industries, Inc. CDSOPT590TMedline Industries, Inc. · Orthopedic tray1 recall0 reports
- Medline Industries, Inc. CDS984556MMedline Industries, Inc. · Orthopedic tray1 recall0 reports
- Medline Industries, Inc. CDSOPT590UMedline Industries, Inc. · Orthopedic tray1 recall0 reports
- Medline Industries, Inc. DYNJ905162QMedline Industries, Inc. · Orthopedic tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99297).
- Z-2764-2026 · Open, ClassifiedMEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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