The Recall Desk
HighFDA (Devices)·Z-0641-2014·Announced 2014-01-15

Sandel Weighted Safety Scalpels Recalled for Exposed Blades

Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, 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 involves a risk-of-harm product (surgical scalpel) where injury has not yet been reported, 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. The recall involves 48 cases (384 units) of the Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade. These devices are manual surgical scalpel blades used for making incisions in various general surgical procedures.

The recall is being issued because the scalpel blade is 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 affected units were distributed worldwide, including nationwide in the United States and in Canada.

Healthcare facilities and consumers should stop using these devices immediately. The source text does not specify a particular action for disposal or return, but users should verify if their devices match the description of the exposed blade defect.

The recalled product

Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 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 2220-N LN 1793

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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