Recall Record: Class II Recall: Medline medical convenience kits, labeled as: 1) SINUS… by Medline Industries, LP

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; 12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I; 13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J; 14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K. 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

Why was Medline medical convenience kits, labeled as: 1) SINUS PA recalled?

FDA's recall record states the reason as: Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

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-2994-2026.

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… →