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

FDA device recall Z-2765-2026 · posted 2026-07-23 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

OJH

Quantity affected

318 kits

Distribution

US: Mo, CO, IL

Date initiated

2026-06-08

Date posted

2026-07-23

Location

Northfield, IL