The Recall Desk
HighFDA (Devices)·Z-0720-2025·Announced 2025-01-01

Medline surgical procedure kits recalled due to endotoxin contamination

Medline brand surgical procedure convenience kits in specific lots contain higher-than-expected endotoxin levels in surgical patties and strips. The contamination was found in raw materials used to produce sterile components.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving confirmed out-of-specification endotoxin contamination in sterile surgical components, which constitutes a risk-of-harm product where injury has not yet been reported. Per the rubric, Class II recalls without reported hospitalization or injury are rated as High severity.

Plain-English summary

Medline Industries is recalling medical procedure convenience kits containing surgical patties and strips in 38 different SKU configurations from specific manufacturing lots. Approximately 6,467 kits are affected, labeled with names including SINUS CDS-1, NASAL PACK, FESS PACK-POB, SINUS PACK, ENT PACK, TRANSPHENOIDAL PACK, HEAD AND NECK PACK, and others.

The surgical patties and strips in these kits were found to contain higher-than-expected levels of endotoxin in the raw material used to produce the sterile components. This resulted in out-of-specification endotoxin levels in the finished goods. Endotoxin is a bacterial component that can trigger inflammatory responses and pyrogenic reactions when present in sterile medical products.

The recalled kits were distributed nationwide in the United States and in Canada. Healthcare facilities and providers who have received affected kits should stop using them and contact Medline Industries for guidance on returns or replacements. Affected lot numbers are identified by UDI-DI and SKU code. No illnesses or injuries have been reported to date.

The recalled product

Product
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical procedure kits
Hazard
Affected units
6,467

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)

  • UDI-DI: CDS982901F
  • 10889942216970 (each)
  • 40889942216971 (case)
  • Lot Numbers: 23HBQ152
  • UDI-DI: DYNJ17493G
  • 10195327224424 (each)
  • 40195327224425 (case)
  • Lot Numbers: 23GBW775
  • UDI-DI: DYNJ33520A
  • 10884389851333 (each)
  • 40884389851334 (case)
  • Lot Numbers: 23HDB834
  • UDI-DI: DYNJ44845G
  • 10889942712311 (each)
  • 40889942712312 (case)
  • Lot Numbers: 23HBF195
  • UDI-DI: DYNJ48330B
  • 10195327113506 (each)
  • 40195327113507 (case)
  • Lot Numbers: 23HBO622

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 10 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · endotoxin contamination

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