Sandel Weighted Safety Scalpels Recalled for Exposed Blades
Ansell Sandel Medical Industries LLC is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, compromising sterility and causing injury.
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 risk-of-harm product (exposed surgical blade compromising sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ansell Sandel Medical Industries LLC is recalling specific lots of Sandel Weighted Safety Scalpels. The affected devices are manual surgical scalpel blades used for making incisions in general surgical procedures. The recall involves 15 cases (1,440 units), 96 cases (96 units), and 96 cases (2,880 units) of the product.
The recall is being issued because the scalpel blade is packaged exposed beyond the safety shield. This defect could compromise the integrity of the package and the sterility of the scalpel, leading to injury. The product was distributed worldwide, including nationwide in the United States and in Canada.
Healthcare facilities and consumers should stop using the affected Sandel Weighted Safety Scalpels immediately. The device listing number is D129456, and the model number is 2211-N. Affected lots include LN 2782 (September 2015), LN 1413 (April 2016), and LN 1623 (May 2016).
The recalled product
- Product
- Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China…
- Manufacturer
- Ansell Sandel Medical Industries LLC
Distribution
Part of a larger recall action
This product is one of 7 recalled by Ansell Sandel Medical Industries LLC 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 7 products in this recall →Related recalls
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