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.
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. 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 C
- 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
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
FDA (Devices) · 2014-01-15
- 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
FDA (Devices) · 2014-01-15
Same hazard · cut injury
See all →- HighHALO Tumblers with Metal Straws Recalled for Laceration Hazard
CPSC · 2024-10-31
- HighPrimal Kitchen Avocado Oil Recalled for Glass Bottle Breakage Risk
FDA (Food) · 2024-07-24
- HighMultichem IA Plus and Controls Recalled Due to Broken Glass Vials
FDA (Devices) · 2023-10-18
- ModerateWinnebago Travel Trailers Recalled for Sharp Cabinet Door Handles
NHTSA · 2022-11-29
- HighMountain Trail Mix recalled due to glass contamination
FDA (Food) · 2021-10-27