The Recall Desk
HighFDA (Devices)·Z-0638-2014·Announced 2014-01-15

Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades

Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades may be exposed, 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 harm (injury) due to compromised sterility, but the source text does not report any actual 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. The product consists of a #3 disposable safety handle with a #11 blade, manufactured in China and packaged in Mexico. The recall involves 96 cases, totaling 288 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 devices and contact the recalling firm for instructions.

The recalled product

Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 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

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 2211-L LN 2962

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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