ECONO STERILE medical procedure kits recalled for potential sterile barrier breach
Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits nationwide due to packaging issues that may breach the sterile barrier. No injuries or illnesses have been reported.
What this means for you
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: The recall involves potential breach of the sterile barrier on medical procedure kits, which poses a risk-of-harm to patients if contamination occurs. Although this is a Class II FDA recall with no reported illnesses to date, the potential for serious infection from a compromised sterile barrier on medical instruments justifies a High severity rating.
Plain-English summary
Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits due to reports of packaging issues that may result in a breach of the sterile barrier. The recalled products are: SIMS UTERINE CURETTE #3 STER25 (Model 96-4113, Lot SK-133), KEVORK ENDO CURET W/BAS STER25 (Model 96-4144A, Lot HSC21), and KEVORKIAN CURET W/O BAS STER25 (Model 96-4145A, Lot HSC21). These kits are used in cervical procedures.
The affected products were distributed nationwide. A breach in the sterile barrier could allow contamination of the instruments, which could potentially result in infection if the kits are used in procedures.
No illnesses or injuries related to this issue have been reported to date. Any healthcare facility or provider who has received these products should contact Sklar Instruments or the FDA with questions regarding the recall.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- packaging-defect
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 (9)
- 1) 96-4113
- UDI/DI 50649111492899
- Lot codes: SK-133
- 2) 96-4144A
- UDI/DI 50649111492523
- Lot codes: HSC21
- 3) 96-4145A
- UDI/DI 50649111492608
- Lot codes: HSC21.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03