The Recall Desk
HighFDA (Devices)·Z-0938-2025·Announced 2025-01-22

Surgical Suction Tubes Recalled for Sterile Packaging Defects

ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical 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 involving medical devices with potential sterile barrier compromise. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score at this level.

Plain-English summary

Sklar Instruments is recalling ECONO STERILE medical procedure kits containing suction and surgical tubes. Affected products include Yankauer suction tubes (Models 96-4176 and 96-4177), Frazier tubes (Models 96-5434 through 96-5440), and Baron suction tubes (Models 96-5492 through 96-5494). A total of 150 units with lot codes FSS4, FSS5, or FSS6 were distributed nationwide.

The recall was initiated due to reports of various packaging issues that may result in a breach of the sterile barrier. Compromised sterile packaging could allow contamination of medical instruments before use, creating potential infection risk during surgical procedures.

Healthcare facilities and medical professionals who have received these affected devices should verify the lot codes on their products. Contact with Sklar Instruments is recommended for instructions on return, replacement, or product verification.

The recalled product

Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO
Manufacturer
Sklar Instruments
Category
Medical Device — Surgical instruments
Hazard
  • sterile-barrier-compromise
  • packaging-defect

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)

  • 1) 96-4176
  • UDI/DI 50649111493674
  • Lot codes: FSS4
  • FSS5
  • 2) 96-4177
  • UDI/DI 50649111493681
  • 3) 96-5434
  • UDI/DI 50649111493612
  • 4) 96-5435
  • UDI/DI 50649111493629
  • FSS6
  • 5) 96-5436
  • UDI/DI 50649111493636
  • 6) 96-5437
  • UDI/DI 50649111493643
  • 7) 96-5438
  • UDI/DI 50649111493650
  • 8) 96-5439
  • UDI/DI 50649111493667
  • 9) 96-5440

Distribution

Distributed nationwide across the United States.

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