The Recall Desk
HighFDA (Devices)·Z-2416-2023·Announced 2023-08-23

Endoscopic Grasper Instrument Recalled for Rotation Knob Failure Risk

Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer DIAMOND-TOUCH GRASPER endoscopic surgical instrument due to a manufacturing defect that may cause the rotation knob to crack or break, potentially compromising surgical performance.

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 a Class II recall with no reported illnesses or injuries. Per the severity rubric, it qualifies as High (3) as a risk-of-harm product—a surgical instrument where a manufacturing defect could compromise function—where injury has not yet been reported.

Plain-English summary

Carefusion 2200 Inc is recalling the Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED endoscopic surgical instrument (Reference SP90-7018, Lot Number B23). A total of 3 units have been distributed to the US and Canada.

The recall was initiated due to a manufacturing defect involving the incorrect use of adhesive during production. This defect may cause the rotation knob to crack or break.

A cracked or broken rotation knob could compromise the device's functionality during endoscopic surgical procedures. Healthcare facilities and providers in possession of these units should verify the lot number and reference number against the recall information and discontinue use of affected devices.

The FDA classified this as a Class II recall. The device's unique identifier (UDI/DI) is 10885403159701. Additional details are available at the FDA website using recall number Z-2416-2023.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Endoscopic Surgical Instruments
Hazard
  • rotation-knob-cracking
  • manufacturing-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 (2)

  • UDI/DI 10885403159701
  • Lot Number B23

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category