Sandel Weighted Safety Scalpels Recalled for Exposed Blades
Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.
What this means for you
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 injury due to compromised sterility, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ansell Sandel Medical Industries LLC is recalling select lots of Sandel Weighted Safety Scalpels. The affected products are the 2215-L Weighted Safety Scalpel, #3L Handle with #15 Blade, packaged in boxes of 12. The recall involves 96 cases, totaling 1,920 units.
The recall is being issued 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 injury. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and in Canada. Specific US states listed include 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. Users should stop using the affected scalpels and contact the recalling firm for instructions.
The recalled product
- Product
- Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 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 C
- Manufacturer
- Ansell Sandel Medical Industries LLC
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)
- 510 K exempt Device Listing Number D129456 Model Number 2215-L LN 2052
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
Same manufacturer · Ansell Sandel Medical Industries LLC
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
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- HighSandel Weighted Safety Scalpels Recalled Due to Exposed Blades
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