FDA Issues Correction Notice for Medline Convenience Kits Containing ICU Medical Pain Management Components (June 8, 2026)

Summary

On June 8, 2026, the FDA issued a correction notice for Medline convenience kits containing ICU Medical pain management components and Huons bupivacaine hydrochloride in dextrose injection. This is a Class I recall, the most serious type. Continued use of uncorrected products may cause serious injury or death. Exporters should verify inventory, lots, and UDI, and improve labeling and post-market surveillance processes.

Source and Applicability

• Source: FDA CDRH News & Updates
• Original publication date: August 12, 2026
• Article date: August 14, 2026
• Source link: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/convenience-kit-correction-medline-issues-correction-convenience-kits-containing-icu-medical-pain

This article is compiled from public information from FDA CDRH News & Updates. Specific requirements are subject to the latest official release by the regulatory authority.

Full Translation of Core Content

This recall involves corrections to certain devices, not their removal from the point of use or sale. The FDA has identified this recall as the most serious type. Continued use of the device without correction may cause serious injury or death.

Affected Products

The FDA has learned that Medline has sent letters to affected customers recommending correction of specific convenience kits by removing components affected by the Huons Co., Ltd. recall before continued use. The affected devices are as follows:

• Product Description: Total Knee CDS; SKU: CDS983930J; UDI/DI (single): 10193489512298; UDI/DI (case): 40193489512299; Lot: 25KBL209
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556L; UDI/DI (single): 10195327554996; UDI/DI (case): 40195327554997; Lot: 24JDC180
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556L; UDI/DI (single): 10195327554996; UDI/DI (case): 40195327554997; Lot: 24HDA321
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556M; UDI/DI (single): 10198459180248; UDI/DI (case): 40198459180249; Lot: 25ADB327
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556N; UDI/DI (single): 10198459266621; UDI/DI (case): 40198459266622; Lot: 26EDA285
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556N; UDI/DI (single): 10198459266621; UDI/DI (case): 40198459266622; Lot: 26DDA718
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556N; UDI/DI (single): 10198459266621; UDI/DI (case): 40198459266622; Lot: 26BDB740
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556N; UDI/DI (single): 10198459266621; UDI/DI (case): 40198459266622; Lot: 26ADB079
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556N; UDI/DI (single): 10198459266621; UDI/DI (case): 40198459266622; Lot: 26ADA161
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556N; UDI/DI (single): 10198459266621; UDI/DI (case): 40198459266622; Lot: 25KDB472
• Product Description: LISTON Hip CDS-LF; SKU: CDS984556N; UDI/DI (single): 10198459266621; UDI/DI (case): 40198459266622; Lot: 25GDA213
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590T; UDI/DI (single): 10195327555009; UDI/DI (case): 40195327555000; Lot: 24GDA740
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590U; UDI/DI (single): 10198459180255; UDI/DI (case): 40198459180256; Lot: 26EDA279
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590U; UDI/DI (single): 10198459180255; UDI/DI (case): 40198459180256; Lot: 26BDB734
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590U; UDI/DI (single): 10198459180255; UDI/DI (case): 40198459180256; Lot: 26ADA474
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590U; UDI/DI (single): 10198459180255; UDI/DI (case): 40198459180256; Lot: 25LDA001
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590U; UDI/DI (single): 10198459180255; UDI/DI (case): 40198459180256; Lot: 25KDB325
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590U; UDI/DI (single): 10198459180255; UDI/DI (case): 40198459180256; Lot: 25GDB517
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590U; UDI/DI (single): 10198459180255; UDI/DI (case): 40198459180256; Lot: 25FDB017
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590U; UDI/DI (single): 10198459180255; UDI/DI (case): 40198459180256; Lot: 25DDA155
• Product Description: LISTON Total Knee-LF; SKU: CDSOPT590U; UDI/DI (single): 10198459180255; UDI/DI (case): 40198459180256; Lot: 24LDA248
• Product Description: Total Knee Pack; SKU: DYNJ905162Q; UDI/DI (single): 10198459235900; UDI/DI (case): 40198459235901; Lot: 26CBD346
• Product Description: Total Knee Pack; SKU: DYNJ905162Q; UDI/DI (single): 10198459235900; UDI/DI (case): 40198459235901; Lot: 25KBU219

Actions Required

Do not use the bupivacaine hydrochloride contained in the affected kits. Check your inventory for convenience kits containing bupivacaine hydrochloride in dextrose injection and quarantine these products until overlay labels are provided. All other components in the kit may continue to be used.

On June 8, Medline sent a letter to all affected customers recommending the following actions:

• Immediately check inventory for affected items and lot numbers. Quarantine all affected products.
• Complete the recall response form to obtain overlay labels to affix to affected inventory.
• Affix overlay labels to affected products. The labels provide staff with instructions to remove and discard the affected components before using the kit.
• If you have distributed, resold, or transferred affected products to other companies or individuals, inform them of this recall.

Reason for Correction

Medline is recalling specific Medline kits containing ICU Medical, Inc. pain management kits, which include Huons' bupivacaine hydrochloride in dextrose injection (USP). Huons Co., Ltd. has initiated a recall of bupivacaine hydrochloride in dextrose injection (USP). Risks of using compromised injectables include infection, inflammatory reactions, and/or reduced anesthetic effect. When used in the intrathecal space, there is a risk of cerebrospinal fluid contamination and meningitis, which may progress to encephalitis and require emergency conversion to general anesthesia.

As of June 8, Medline has not reported serious injuries or deaths related to this issue.

Device Use

Convenience kits contain various surgical instruments, dressings, and/or other materials, as well as drug components intended for use in various surgical procedures.

Contact Information

U.S. customers with questions about this recall should call Medline Industries at 1-866-359-1704 or email recalls@medline.com.

What Does This Information Mean for Medical Device Companies?

Information such as this from FDA CDRH News & Updates should first be incorporated into a company's regulatory intelligence and post-market surveillance, rather than merely viewed as general news. Companies need to determine whether the update is a guidance document, recall safety, product approval, digital health, quality system, or post-market regulatory information, and confirm whether it affects existing registration projects or products under development.

If the content involves specific products, testing performance, risk alerts, or regulatory actions, companies should further assess whether it affects product classification, 510(k), De Novo, PMA pathways, technical files, labeling, quality system records, or post-market reporting obligations. For companies advancing U.S. market registration, the original link, publication date, scope of applicability, and internal conclusions should be recorded in the project ledger.

What Materials Should Companies Focus on Reviewing?

It is recommended to review the product classification basis, applicable regulatory clauses, predicate device or equivalence determination, performance testing, software and cybersecurity documentation, risk management, clinical evidence, labeling, and quality system readiness.

Common Risks

Common risks include: misjudging the FDA pathway, ignoring changes in guidance documents, insufficient performance testing design, overly broad labeling claims, unclear post-market reporting obligations, and directly applying materials from other markets to U.S. registration.

AIMEILI Regulatory Interpretation and Business Impact

The Medline convenience kit correction notice published by the FDA appears to target the recall of bupivacaine hydrochloride injection components contained in surgical convenience kits. In reality, it reflects stricter regulatory scrutiny of "device + drug" combination products and higher requirements for post-market labeling corrections and quality traceability. For Chinese medical device manufacturers, especially those exporting to the U.S. market or planning to register convenience kit products through the FDA 510(k)/De Novo pathways, this should be examined from four dimensions: combination product classification, supply chain risk, labeling management, and post-market surveillance.

Registration Pathway and Classification

First, at the registration pathway and classification level, the products involved are not purely medical devices but convenience kits containing a drug component (bupivacaine hydrochloride). When evaluating such combination products, the FDA applies both medical device regulations (21 CFR Part 800 series) and drug-related requirements. When planning to bring such products to the U.S. market, Chinese companies cannot prepare technical files solely according to device requirements; they must also determine whether the product is considered a combination product due to its drug component, which may require additional FDA drug evaluation or stricter risk management. If the product is planned to clear through the 510(k) pathway, it is necessary to confirm substantial equivalence with a marketed product, especially whether the drug-containing component is within the permitted regulatory scope.

Technical Files and Clinical Evaluation

Second, in terms of technical files and clinical evaluation, this recall indicates that drug-containing components may pose clinical risks due to contamination, endotoxins, or stability issues of active ingredients. Chinese companies should re-evaluate their risk management documentation, list microbial contamination, pyrogenic reactions, and neurotoxicity of injectable components as key hazards, and supplement relevant data in biocompatibility, sterilization validation, and stability testing. If a product contains the same components as an international supplier, even if not directly involved in this recall, companies should proactively search supply chain information and assess whether technical files need updating or change applications need resubmission, to avoid being passively involved in FDA enforcement actions due to upstream supplier quality issues.

Labeling and Instructions for Use

Third, in terms of labeling and instructions for use, the FDA requires correction of label information through "overlay labels," which suggests that companies must reserve space for updatable, overlay labels in product label design and establish clear label change control procedures. For companies exporting to the U.S., labels should include UDI codes, and UDI information must be accurately searchable in the GUDID database. At the same time, a batch traceability system for laboratories and inventory should be established to ensure that upon receiving similar recalls or safety alerts, affected batches can be quickly identified and quarantine, correction, and distributor notification can be implemented.

Post-Market Maintenance and Regulatory Response

Finally, from the perspective of post-market maintenance and regulatory response, this correction notice is a Class I recall, the most serious type, but the FDA still allows correction through overlay labels rather than physical removal of all kits. This indicates that the FDA encourages more efficient labeling corrections in recall handling, provided that companies have sufficiently robust recall response plans and distributor notification mechanisms. When establishing quality management systems, Chinese companies should incorporate such FDA recall cases into management review inputs, update complaint handling and recall management procedures, strengthen oversight responsibilities for overseas agents and distributors, and ensure that in similar events, inventory quarantine, response form submission, overlay label production, and downstream notification can be completed quickly, thereby reducing regulatory penalties and reputational damage risks.

FAQ

Does an FDA public page update necessarily represent a regulatory change?

Not necessarily. It is necessary to distinguish between news, guidance, database pages, recall information, and formal regulatory documents. Important content should be judged by returning to the original FDA text and applicable regulations.

What should companies do after seeing an FDA update?

It is recommended to first determine whether it affects product classification, registration pathway, technical files, or post-market obligations, and then decide whether to update the project plan.

Content Review and Applicability Boundaries

Content author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team. Source principle: Prioritize official regulatory agencies, international organizations, standards organizations, and public regulatory materials; industry media and project experience are only auxiliary references. Applicability boundaries: This article is for preliminary understanding, material preparation, and project planning, and does not replace the formal requirements of the target country's regulatory authority, testing conclusions, or legal advice.

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