CLASS II Device recall · Reported 15 Jan 2014 · FDA Enforcement Report

Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled

Ansell Sandel Medical Industries is recalling Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with, distributed nationwide in the US. The recall was initiated on 12 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes510 K exempt Device Listing Number D129456 Model Number 2210-N LN 0563 Jan 2016 LN 2263 Jul 2016

Quantity recalled50 cases (4800 units); 96 cases (576 units)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0635-2014
FDA event ID: 67005
Recalling firm: Ansell Sandel Medical Industries, Chatsworth, CA
Classification: Class II
Status: Terminated
Recall initiated: 12 Nov 2013
FDA classified: 7 Jan 2014
Reported: 15 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

12 Nov 2013	Recall initiated by company
7 Jan 2014	Classified by FDA	+56 days
15 Jan 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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 Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.

Where it was distributed

Worldwide Distribution: US (nationwide) including states of: 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 country of: Canada.

Nationwide Alabama California Colorado Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Minnesota Mississippi North Carolina Nebraska New York Oklahoma

Questions about this recall

Why was it recalled?

Which lots are affected?

510 K exempt Device Listing Number D129456 Model Number 2210-N LN 0563 Jan 2016 LN 2263 Jul 2016

Where was it sold?

Worldwide Distribution: US (nationwide) including states of: 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 country of: Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 67005

This product is part of a recall event; the main page for the event is Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled.

Reported	Class	Recall	Company	Reason	Where
15 Jan 2014	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled	Ansell Sandel Medical Industries	Sterility	Nationwide
15 Jan 2014	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled	Ansell Sandel Medical Industries	Sterility	Nationwide
15 Jan 2014	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled	Ansell Sandel Medical Industries	Sterility	Nationwide
15 Jan 2014	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# recalled	Ansell Sandel Medical Industries	Sterility	Nationwide
15 Jan 2014	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled	Ansell Sandel Medical Industries	Sterility	Nationwide
15 Jan 2014	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled	Ansell Sandel Medical Industries	Sterility	Nationwide

More recalls from Ansell Sandel Medical Industries

All 7

Reported	Class	Recall	Company	Reason	Where
15 Jan 2014Device	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled	Ansell Sandel Medical Industries	Sterility	Nationwide
15 Jan 2014Device	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled	Ansell Sandel Medical Industries	Sterility	Nationwide
15 Jan 2014Device	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# recalled	Ansell Sandel Medical Industries	Sterility	Nationwide
15 Jan 2014Device	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled	Ansell Sandel Medical Industries	Sterility	Nationwide
15 Jan 2014Device	CLASS II	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 recalled	Ansell Sandel Medical Industries	Sterility	Nationwide

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All 3,809

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2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide