Agency classClass IIOur severity:High FDA (Devices)·Z-0635-2014·Announced 2014-01-15

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 and involves a risk of harm (injury) due to compromised sterility, 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 select lots of Sandel Weighted Safety Scalpels, specifically the #3 Disposable Safety Handle with #10 Blade. The affected products are manufactured in China and packaged in Mexico. The recall involves 50 cases (4,800 units) and 96 cases (576 units) of the device.

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 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. The affected lots are identified by Lot Number 0563 (January 2016) and Lot Number 2263 (July 2016). Users should stop using these devices and contact the recalling firm for instructions.

The recalled product

Product: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 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 China…
Manufacturer: Ansell Sandel Medical Industries LLC
Category: Medical Device — Surgical Instruments
Hazard: injury
sterility-compromise

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

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 →

Same manufacturer · Ansell Sandel Medical Industries LLC

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Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades
FDA (Devices) · 2014-01-15
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Sandel Weighted Safety Scalpels Recalled for Exposed Blades
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Sandel Weighted Safety Scalpels Recalled for Exposed Blades
FDA (Devices) · 2014-01-15
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Sandel Weighted Safety Scalpels Recalled for Exposed Blades
FDA (Devices) · 2014-01-15
High
Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades
FDA (Devices) · 2014-01-15

Same hazard · injury