Endoscopic surgical graspers recalled for potential rotation knob failure
Carefusion is recalling specific lots of Snowden-Pencer surgical graspers used in endoscopy due to a manufacturing defect that could cause the rotation knob to crack or break. The affected instrument may malfunction during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall involving a mechanical defect in a surgical instrument with no reported hospitalizations or injuries. The hazard—cracking or breaking of the rotation knob—is a real manufacturing defect that could compromise instrument function during surgery, qualifying it as a risk-of-harm product with no reported adverse incidents.
Plain-English summary
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER (5mm, 45cm, ratcheted model, part number SP90-7220) used in endoscopic surgical procedures. The recall affects lots B23 and C23, distributed in the United States and Canada.
The product has been found to have a manufacturing defect involving the incorrect application of adhesive during production. This defect can cause the rotation knob to crack or break, potentially compromising the surgeon's ability to control the instrument during a procedure.
No injuries or illnesses related to this defect have been reported to date. However, the potential for malfunction during surgery poses a risk to patient and surgical team safety.
Patients or healthcare providers who have received this product should contact Carefusion to determine if their instrument is from an affected lot and to arrange replacement or corrective action.
The recalled product
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopic surgical device
- Manufacturer
- Carefusion 2200 Inc
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 10885403161278
- Lot Numbers: B23
- C23
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Carefusion 2200 Inc 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 15 products in this recall →Related recalls
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