Recall Record: Class I Recall: MEDLINE medical procedure convenience kit labeled as: HIP… by Medline Industries, LP

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Medline Industries, LP. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Medline Industries, LP should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Medline Industries, LP directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Medline Industries, LP’s FDA history

Argus HQ has recorded 293 total FDA actions tied to Medline Industries, LP: 0 warning letters, 293 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Why was MEDLINE medical procedure convenience kit labeled as: HIP recalled?

FDA's recall record states the reason as: 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.

Who should I contact about this recall?

Contact Medline Industries, LP directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Medline Industries, LP had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 293 total FDA actions tied to Medline Industries, LP, including 293 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2764-2026.

Related enforcement actions

• Recall: Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product… →
• Recall: Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product N… →
• Recall: Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Pro… →
• Recall: Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count,… →
• Recall: Medline Industries, LP — Class I recall: MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medlin… →
• Recall: Medline Industries, LP — Class II recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French size… →
• Recall: Medline Industries, LP — Class I recall: MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G →
• Recall: Medline Industries, LP — Class II recall: Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ… →