Intuitive Recalls da Vinci Harmonic ACE Curved Shears Due to Sterility Risk
Intuitive Surgical is recalling da Vinci Harmonic ACE Curved Shears because sterile packaging may be damaged during transit, potentially compromising sterility.
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 involves a potential breach in sterility for a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 43,755 units of da Vinci Harmonic ACE Curved Shears. The recall was initiated after an internal inspection revealed that the sterile packaging for these inserts may become damaged during transit. The potential damage includes pinholes or small openings on the pouch, which could lead to a breach in sterility.
The affected products were distributed in the United States and numerous international locations, including Australia, Canada, China, Germany, India, Japan, and the United Kingdom. The recall covers all lots of the product.
Healthcare providers and facilities should stop using the affected inserts and contact Intuitive Surgical for further instructions on how to return or dispose of the products. Patients who have had procedures using these instruments should contact their healthcare provider if they have concerns regarding the sterility of the equipment used.
The recalled product
- Product
- daVinci Harmonic ACE Curved Shears
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 43,755
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 (1)
- All Lots
Distribution
Distribution scope not specified by the agency.
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