Intuitive Surgical Recalls 8mm Large Hem-O-Lok Clip Applier Devices
Intuitive Surgical is voluntarily recalling 509 units of 8mm Large Hem-O-Lok Clip Appliers due to a Class II device defect. The affected instruments were distributed to facilities in eight US states.
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: The recall is classified as FDA Class II, which indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is voluntarily recalling 509 units of the 8mm Large Hem-O-Lok Clip Applier. These devices are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The recall was initiated on November 3, 2014, and was classified as Class II by the FDA.
The affected units are identified by part number 470230-04 and are specifically the 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. The recall status is currently terminated, with the termination date recorded as February 3, 2015.
The devices were distributed in the United States to facilities in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts. The source text does not specify the exact nature of the defect or the reason for the recall, nor does it report any specific injuries or illnesses associated with the use of these devices.
The recalled product
- Product
- 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 509
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)
- Part number
- 470230-04
Distribution
Part of a larger recall action
This product is one of 22 recalled by Intuitive Surgical, 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.
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