Recall Z-2764-2026 ยท LRO General Surgery Tray
Medline Industries, LP
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
| Date | Jul 23, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 t |
| Quantity | 52 kits |
| Distribution | US: Mo, CO, IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213481 | Medline General Surgery Tray Medline Industries, Inc., May 24, 2022 |