Incisive Surgical Recalls INSORB Subcuticular Skin Staplers Due to Sterility Concerns
Incisive Surgical Inc is recalling 1,200 units of INSORB Subcuticular Skin Staplers (Ref 2030) due to a possible compromise of the sterile barrier integrity.
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 and involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Incisive Surgical Inc is recalling 1,200 units of the INSORB Subcuticular Skin Stapler, Reference 2030. The recall is being conducted because of a possible compromise of the sterile barrier integrity of the devices.
The affected units are identified by UDI 10867516000101 and Lot Number 182801. The distribution pattern for these units is listed as Israel. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Patients who have received these devices should contact their healthcare provider for further instructions.
The recalled product
- Product
- INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
- Manufacturer
- Incisive Surgical Inc
- Affected units
- 1,200
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)
- UDI 10867516000101 Lot Number 182801
Distribution
Distribution scope not specified by the agency.
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