The Recall Desk
HighFDA (Devices)·Z-0726-2025·Announced 2025-01-01

Surgical procedure kits recalled for elevated endotoxin levels

Medline surgical kits containing sterile surgical patties and strips have been recalled due to higher-than-expected endotoxin levels in raw materials. The affected supplies may pose a risk during sterile surgical procedures.

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 of surgical kit components with out-of-specification endotoxin contamination. Endotoxin in sterile surgical supplies poses a risk of infection during surgical procedures. No illnesses or injuries have been reported, placing this at the 'High' level per the rubric.

Plain-English summary

Medline Industries has recalled 22,970 custom convenience surgical kits containing sterile Codman surgical patties and strips. The kits were distributed nationwide in the United States and in Canada and are used in procedures including craniotomy, laminectomy, and spinal reconstruction.

Medline discovered that surgical patties and strips in specific lots of these kits contained higher-than-expected levels of endotoxin in the raw materials used for production, which may have resulted in out-of-specification endotoxin levels in the finished products. Endotoxin, a bacterial byproduct, can pose a risk during sterile surgical procedures if present in elevated levels.

Affected healthcare facilities should identify recalled kits using the product SKUs and lot numbers provided in the FDA recall notice. Kits should be removed from use and stored separately. Facilities should contact Medline Industries for replacement, refund, or disposal instructions.

No illnesses or injuries have been reported in connection with this recall. Healthcare providers should verify whether they have received affected product and take appropriate action based on the recall notice.

The recalled product

Product
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6)
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical kits
Hazard
Affected units
22,970

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: CDS780045N
  • 10193489355406 (each)
  • 40193489355407 (case)
  • Lot Numbers: 22JBI816 22JBI817
  • UDI-DI: CDS780119U
  • 10193489371116 (each)
  • 40193489371117 (case)
  • UDI-DI: CDS780119V
  • 10195327114916 (each)
  • 40195327114917 (case)
  • Lot Numbers: 22FBU189 22DBN874
  • UDI-DI: CDS981753K
  • 10193489848946 (each)
  • 40193489848947 (case)
  • Lot Numbers: 22DLA844
  • UDI-DI: CDS981923X
  • 10195327434298 (each)
  • 40195327434299 (case)
  • Lot Numbers: 23HBS882
  • UDI-DI: CDS982719Q

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

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