FDA Class II Recall: Medline convenience kits labeled as: 1) MAJOR GYN… by Medline Industries, LP

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G; 7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A; 8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B; 9) DIEP FLAP, Medline Kit SKU DYNJ910832A; 10) C-SECTION, Medline Kit SKU DYNJ911236; 11) LAPAROTOMY, Medline Kit SKU DYNJ911243; 12) OPEN HEART A&B, Medline Kit SKU DYNJ911245; 13) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332; 14) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332A. 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 II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. 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 II, 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 360 total FDA actions tied to Medline Industries, LP: 0 warning letters, 360 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

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 360 total FDA actions tied to Medline Industries, LP, including 360 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-3024-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions

• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2)… →
• Recall: Medline Industries, LP — Class II recall: Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS… →
• Recall: Medline Industries, LP — Class II recall: Medline convenience kits containing Healthmark Instrument Channel Brushes. SIN… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2)… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197;… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784;… →
• Recall: Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A →
• Recall: Medline Industries, LP — Class I recall: Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB31… →