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.
FDA Recall Z-2765-2026 · Posted 2026-07-23
Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2026-06-08
Product Quantity318 kits
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.
Firm 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].
Root Cause
Nonconforming Material/Component
Distribution Pattern
US: Mo, CO, IL
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.