The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2765-2026·Announced 2026-07-29

MEDLINE Medical Procedure Kits Containing Bupivacaine Recalled Due to Drug Ineffectiveness

Medline Industries is recalling 318 medical procedure kits that contain ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection due to quality issues that could result in drug ineffectiveness.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall classification with documented quality issues that could result in drug ineffectiveness. Per rubric, FDA Class I recalls never go below severity 4.

Plain-English summary

The U.S. Food and Drug Administration has authorized the recall of MEDLINE medical procedure convenience kits. These kits are labeled as TOTAL KNEE-LF, TOTAL KNEE CDS, HIP CDS-LF, and TOTAL KNEE PACK with various Medline kit SKUs. The 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.

The affected kits were distributed in the United States in Missouri, Colorado, and Illinois. The recalling firm, Medline Industries, LP, has identified 318 kits affected by this recall. No illnesses or injuries have been reported in connection with this recall.

Healthcare facilities and patients should immediately stop using the affected kits. Affected kits should be returned to Medline Industries, LP for a full refund. Consumers with questions should contact Medline customer service.

The recalled product

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…
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical/Procedure Kit
Hazard
Affected units
318

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • Kit Lot Number 26BDB734
  • Kit Lot Number 26ADA474
  • Kit Lot Number 25LDA001
  • Kit Lot Number 25KDB325
  • Kit Lot Number 25GDB517
  • Kit Lot Number 25FDB017
  • Kit Lot Number 25DDA155
  • 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

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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