Z-0636-2014Class II

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

Name: Z-0636-2014 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade...
Creator: Ansell Sandel Medical Industries LLC
Published: 2013-11-12
License: https://open.fda.gov/license/

Ansell Sandel Medical Solutions LLC / initiated 2013-11-12 / Terminated / root cause: packaging

FDA source

Ansell Sandel Medical Industries LLC began a recall of Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736... on 2013-11-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0636-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-12
Posted: 2014-01-08
Terminated: 2016-04-06
Recalling firm: Ansell Sandel Medical Solutions LLC
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 Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
Product code: GDZ Handle, Scalpel
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: The firm, Ansell, sent an "URGENT: VOLUNTARY RECALL OF ANSELL SANDEL WEIGHTED SAFET SCALPEL" letter dated November 11, 2013 to its customers and posted a website notification on November 11, 2013. The letter described the product, problem and actions to be taken. The customers were instructed: Do not ship SANDEL Weighted Safety Scalpel products 2210-L, 2210-N, 2211-L, 2211-N, 2215-L, 2215-N, or 2220-N to a hospital or end user with the listed lot numbers; quarantine SANDEL Weighted Safety Scalpel products in your inventory; and complete the attached response form and return it to attention: Ansell; via fax at 818-534-2510 or email [email protected]. Additionally, if you have distributed this product to other accounts, please notify them of the voluntary recall and instruct them to return any outstanding stock to you as indicated in the attachment. If you have any questions or need additional information, please contact Customer Service by calling 866-764-3327 (6:00am-5:00pm PST/9:00am-8pm EST) or email [email protected]
Quantity in commerce: 15 cases (1440 units); 96 cases (96 units); 96 cases (2880 units)
Distribution: 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.
Product codes and lots: 510 K exempt Device Listing Number D129456 Model Number 2211-N LN 2782 9/2015 LN 1413 4/2016 LN 1623 5/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0636-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0635-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-07
Z-0636-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-07
Z-0637-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-07
Z-0638-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-07
Z-0639-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-07
Z-0640-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-07
Z-0641-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-07

Product code GDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)