Serious riskFDA DeviceJul 29, 2026Class I

Medline kits recalled for possible bupivacaine ineffectiveness

Medline medical procedure kits used for knee and hip surgeries contain pain management medications with quality issues that could make them less effective. The affected kits were distributed to hospitals and surgical centers in Missouri, Colorado, and Illinois.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

Check your facility's inventory for the recalled kit SKUs: CDSOPT590T, CDSOPT590U, CDS983930J, CDS984556L, CDS984556M, and DYNJ905162Q
Do not use kits with the lot numbers listed in the recall notice
Contact Medline Industries for instructions on returning or replacing affected kits
Review your procedure records if these kits were used, and consult with your medical team about any patients who may have been affected

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 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.
Sold in: US: Mo, CO, IL
Made for: Adults (18 years to 100 years)

This recall covers 2 products — see all of them.

Details

Units affected: 318 kits
Illnesses reported: None reported
Manufactured in: 3 Lakes Dr, N/A, Northfield, IL, United States
Classification: Class I
Recall number: Z-2765-2026

In the FDA's words

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. 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. 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. Distribution: US: Mo, CO, IL Affected quantity: 318 kits
Hazard: 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.

2 products in this recall

Medline procedure kits recalled for bupivacaine ineffectiveness risk

Medline is recalling 370 medical procedure convenience kits across two product entries. The kits include pain management kits made by ICU Medical that contain bupivacaine hydrochloride in dextrose injection, which was recalled over quality issues that could make the drug less effective. No injuries have been reported, and the kits were distributed in Missouri, Colorado, and Illinois.

The agency lists each product separately. Check every one you might have.

MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Z-2764-2026 · 52 kits
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTA… (this page)
Z-2765-2026 · 318 kits