Z-2765-2026Class I

MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL...

Name: Z-2765-2026 MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL...
Creator: Medline Industries, LP
Published: 2026-06-08
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-06-08 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of 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... on 2026-06-08. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2765-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-07-23
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: OJH Orthopedic Tray
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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 [email protected].
Quantity in commerce: 318 kits
Distribution: US: Mo, CO, IL
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2765-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2764-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22
Z-2765-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)