ECONO STERILE Dental Cement Spatula Kits Recalled for Packaging Issues
Sklar Instruments is recalling ECONO STERILE dental cement spatulas (Model 96-2245M) due to packaging defects that may compromise the sterile barrier. The product was distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with packaging defects that may compromise the sterile barrier. No illnesses or injuries reported. Per the rubric, this represents a risk-of-harm product without reported injury, classified as High (3).
Plain-English summary
Sklar Instruments is recalling ECONO STERILE CEMENT SPATULA #24 STRL CS/25 (Model 96-2245M), a dental mixing utensil supplied as sterile packages of 25 units. The affected product was distributed nationwide under lot code 0724962245M.
The recall addresses reports of various packaging defects that may result in a breach of the sterile barrier. For a medical device packaged as sterile, compromise of package integrity affects the sterilization assurance of the product.
Users in possession of affected product should verify their lot number against code 0724962245M and contact Sklar Instruments or the FDA with questions about product replacement or proper handling.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
- Manufacturer
- Sklar Instruments
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 96-2245M
- UDI/DI 50649111448612
- Lot codes: 0724962245M
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Sklar Instruments under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 30 products in this recall →Related recalls
Same manufacturer · Sklar Instruments
See all →- HighSklar Instruments iris hooks recalled for sterile packaging integrity issues
FDA (Devices) · 2025-01-22
- HighECONO STERILE Procedure Kits Recalled for Sterile Barrier Breach Risk
FDA (Devices) · 2025-01-22
- HighSklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues
FDA (Devices) · 2025-01-22
- HighSklar Instruments Sterile Surgical Kits Recalled for Packaging Defects
FDA (Devices) · 2025-01-22
- HighECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues
FDA (Devices) · 2025-01-22
Same hazard · sterile barrier compromise
See all →- HighBARD Dynamic Tip Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- ModerateDisposable Mixing Bowls with Spatula recalled for compromised sterile barrier
FDA (Devices) · 2026-05-06
- SevereTufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
FDA (Devices) · 2025-05-21
- HighIntroducer Needle REF NDL-107-04 Sterile Packaging Recall
FDA (Devices) · 2025-05-14
- HighGalt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue
FDA (Devices) · 2025-05-14
Similar recalls
- HighOral surgery scrapers recalled due to possible inadequate sterilization
FDA (Devices) · 2021-06-09
- ModerateDisposable Mixing Bowls with Spatula recalled for compromised sterile barrier
FDA (Devices) · 2026-05-06
- SevereCustomed Recalls EO Sterilized ENT Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- HighOral Surgery Devices Recalled for Potential Sterility Failures
FDA (Devices) · 2021-06-09
- HighSpinal Surgery Cement Delivery Cannula Kits Recalled for Potential Sterilization Failure
FDA (Devices) · 2021-06-09
- HighZVplasty Directional Cement Cannula recalled for inadequate sterilization
FDA (Devices) · 2021-06-09