CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Econo Sterile medical procedure kits labeled as recalled
Sklar Instruments is recalling Econo Sterile medical procedure kits labeled as: Econo Sterile Scalpel Hdl #3 W/Metric, distributed nationwide in the US. The recall was initiated on 3 Dec 2024 and the FDA has classified it as Class II.
Check your package
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-0937-2025
- FDA event ID
- 95946
- Recalling firm
- Sklar Instruments, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Dec 2024
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 3 Dec 2024 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +44 days |
| 22 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
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
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Where it was distributed
Domestic: Nationwide Distribution
Questions about this recall
Is Econo Sterile medical procedure kits labeled as: Econo Sterile Scalpel Hdl #3 W/Metric recalled?
Yes. Sklar Instruments recalled Econo Sterile medical procedure kits labeled as: Econo Sterile Scalpel Hdl #3 W/Metric on 3 Dec 2024. The recall is Class II and its status is Ongoing. Recall number Z-0937-2025.
Why was it recalled?
Reports of various packaging issues that may result in a breach of the sterile barrier.
Which lots are affected?
96-3500M, UDI/DI 50649111149960, Lot codes: SK-125
Where was it sold?
Domestic: Nationwide Distribution
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.
More recalls from Sklar Instruments
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
| Device | CLASS II | Econo Sterile medical procedure kits labeled as recalled | Sklar Instruments | Sterility | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |