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
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.
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 breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27