Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 15, 2014
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.
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 ste…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ansell Sandel Medical Industries LLC recalled Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with… - a moderate-severity action.
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with… was recalled by Ansell Sandel Medical Industries LLC in January 15, 2014. Reason: Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety …. Check the official notice for the remedy. Verify recall #Z-0636-2014 with the FDA Devices before acting.
The recall
Ansell Sandel Medical Industries LLC issued this moderate-severity FDA Devices recall-Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety ….
- Moderate
- severity level
- Class II
- classification
- January 15, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0636-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0636-2014) was formally reported on January 15, 2014, with the manufacturer initiating the action on November 12, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Ansell Sandel Medical Industries LLC is listed as the recalling firm, operating out of Chatsworth, CA. Federal records list the affected scope as 15 cases (1440 units); 96 cases (96 units); 96 cases (2880 units).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15 cases (1440 units); 96 cases (96 units); 96 cases (2880 units)
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0636-2014 |
| Date reported | January 15, 2014 |
| Date initiated | November 12, 2013 |
| Recalling firm | Ansell Sandel Medical Industries LLC |
| Firm location | Chatsworth, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0636-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ansell Sandel Medical Industries LLC. Units affected: 15 cases (1440 units); 96 cases (96 units); 96 cases (2880 units).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2014. Severity: Moderate. Recall number: Z-0636-2014.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0636-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 15, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.