Sandel Healthcare Safety Devices Weighted Safety Scalpel #3… — Class II medical device recall Z-0639-2014
Terminated recall by Ansell Sandel Medical Industries LLC, reported 2014-01-15, distributed nationwide. Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety s
| Recall number | Z-0639-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ansell Sandel Medical Industries LLC, Chatsworth, CA, United States |
| Recall initiated | 2013-11-12 |
| Classified | 2014-01-07 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2016-04-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | sterility |
| Model numbers | 1203, 1553, 2215-NLN |
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 Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0639-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.