The Recall Desk
HighFDA (Devices)·Z-2428-2023·Announced 2023-08-23

Endoscopic Surgical Grasper Recalled for Potential Rotation Knob Cracking

Carefusion is recalling specific lots of surgical graspers due to potential cracking of the rotation knob caused by incorrect adhesive use in manufacturing. Affected devices may fail during 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: FDA Class II device with potential for failure during use due to manufacturing defect, but no injuries or illnesses have been reported. Classified as 'High' under the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER (Reference SP90-7266), an endoscopic surgical instrument used in minimally invasive surgery.

The recalled devices have the potential to crack or break at the rotation knob due to incorrect adhesive use during manufacturing. Failure of this component during surgical use could impact device function.

The recall affects devices distributed in the United States and Canada with UDI/DI 10885403161513, specifically lot numbers B23 and C23.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Endoscopic Surgery
Hazard
  • manufacturing-defect
  • mechanical-failure

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 (3)

  • UDI/DI 10885403161513
  • Lot Numbers: B23
  • C23

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category