Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades
Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially 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 is classified as FDA Class II. The hazard involves a risk of harm (injury) due to compromised sterility and exposed blades, but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Ansell Sandel Medical Industries LLC is recalling specific lots of Sandel Healthcare Safety Devices Weighted Safety Scalpels. The affected products are Model Number 2210-L, consisting of a #3 Long Disposable Safety Handle with a #10 Blade. The recall involves 13 cases (312 units) from lot number LN 0662 (dated 2/2015) and 24 cases (1,176 units) from lot number LN 2052 (dated 6/2015).
The recall was initiated because the scalpel blades are packaged exposed beyond the safety shield. This defect could compromise the integrity of the package and the sterility of the scalpel, leading to potential injury. The products are 510(k) exempt and have Device Listing Number D129456.
The affected scalpels were distributed worldwide, including nationwide in the United States (specifically in AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX, and WI) and in Canada. Users should check their inventory for the specific lot numbers and model numbers listed above. If the products match the recalled description, they should be removed from use and returned to the distributor or manufacturer.
The recalled product
- Product
- Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 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…
- Manufacturer
- Ansell Sandel Medical Industries LLC
- Hazard
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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See all →- HighSandel Weighted Safety Scalpels Recalled Due to Exposed Blades
FDA (Devices) · 2014-01-15
- HighSandel Weighted Safety Scalpels Recalled for Exposed Blades
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- HighSandel Weighted Safety Scalpels Recalled for Exposed Blades
FDA (Devices) · 2014-01-15
- HighSandel Weighted Safety Scalpels Recalled for Exposed Blades
FDA (Devices) · 2014-01-15
- HighSandel Weighted Safety Scalpels Recalled Due to Exposed Blades
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