The Recall Desk
HighFDA (Devices)·Z-0639-2014·Announced 2014-01-15

Sandel Weighted Safety Scalpels Recalled for Exposed Blades

Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, compromising sterility and posing an injury risk.

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 harm (injury) due to compromised sterility and exposed blades, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ansell Sandel Medical Industries LLC is recalling select lots of Sandel Weighted Safety Scalpels, specifically Model Number 2215-N LN 1203 and 1553. The recall involves 4,128 units from lot 1203 and 3,548 units from lot 1553. These devices are manual surgical scalpel blades used for making incisions in general surgical procedures.

The recall was initiated because the scalpel blades in the affected packages are 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. The 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. Healthcare facilities and consumers should stop using these specific lots and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 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 China
Manufacturer
Ansell Sandel Medical Industries LLC
Category
Medical Device — Surgical Instruments
Hazard

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 →

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