Urgent site urgencyFDA Class I

MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T

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.

Agency
FDA Device
Recall date
Jun 8, 2026
Status
Ongoing
Company
Medline Industries, LP

1. What product was recalled?

MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T

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.

Quantity: 318 kits

Code or lot text: 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.

LOT
Kit Lot Number 24GDA740
LOT
Kit Lot Number 24HDA321
LOT
Kit Lot Number 24JDC180
LOT
Kit Lot Number 24LDA248
LOT
Kit Lot Number 25ADB327
LOT
Kit Lot Number 25DDA155
LOT
Kit Lot Number 25FDB017
LOT
Kit Lot Number 25GDB517
LOT
Kit Lot Number 25KBL209
LOT
Kit Lot Number 25KBU219.
LOT
Kit Lot Number 25KDB325
LOT
Kit Lot Number 25LDA001
LOT
Kit Lot Number 26ADA474
LOT
Kit Lot Number 26BDB734
LOT
Kit Lot Number 26CBD346
LOT
Kit Lot Number 26EDA279
LOT
Medline kit SKU CDS983930J
LOT
Medline kit SKU CDS984556L
LOT
Medline kit SKU CDS984556M
LOT
Medline kit SKU CDSOPT590T
LOT
Medline kit SKU CDSOPT590U
LOT
Medline kit SKU DYNJ905162Q
LOT
UDI/DI 10193489512298 (each) 40193489512299 (case)
LOT
UDI/DI 10195327554996 (each) 40195327554997 (case)
LOT
UDI/DI 10195327555009 (each) 40195327555000 (case)
LOT
UDI/DI 10198459180248 (each) 40198459180249 (case)
LOT
UDI/DI 10198459180255 (each) 40198459180256 (case)
LOT
UDI/DI 10198459235900 (each) 40198459235901 (case)
RECALL-NUMBER
Z-2765-2026

MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N

MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N

Quantity: 52 kits

Code or lot text: UDI/DI 10198459266621 (each) 40198459266622 (case), Lot Numbers: 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, 25GDA213.

LOT
25GDA213.
LOT
25KDB472
LOT
26ADA161
LOT
26ADB079
LOT
26BDB740
LOT
26DDA718
LOT
Lot Numbers: 26EDA285
LOT
UDI/DI 10198459266621 (each) 40198459266622 (case)
RECALL-NUMBER
Z-2764-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the 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.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Colorado, Illinois

View source evidence for state distribution
  • Colorado: US: Mo, CO, IL
  • Illinois: US: Mo, CO, IL

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Device source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.