Surgical instrument kits recalled for potential sterile packaging defects
Sklar Instruments is recalling 41,850 units of ECONO STERILE surgical procedure kits due to packaging defects that may compromise the sterile barrier, affecting multiple clamp and hemostat models used in general orthopedic surgery.
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: This is an FDA Class II recall involving packaging defects that could compromise the sterile barrier in surgical instruments. No illnesses or injuries have been reported, fitting the criterion for high-risk products where potential harm could occur but has not yet materialized.
Plain-English summary
Sklar Instruments has recalled 41,850 units of ECONO STERILE surgical instrument kits distributed nationwide. The recall affects 31 different models of surgical instruments, including various clamps, hemostats, and forceps used in general orthopedic surgery.
The kits are being recalled due to packaging defects that may breach the sterile barrier. A compromised sterile barrier could allow the instruments to become contaminated, creating a potential safety risk during surgical procedures.
Healthcare facilities and practitioners with these products should verify whether their instruments are included in the recall by checking their lot numbers and model numbers against the FDA's detailed list. Affected individuals should contact Sklar Instruments or the FDA for guidance on how to proceed.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECO
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- contamination-risk
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 (20)
- 1) 96-2352A
- UDI/DI 50649111488151
- Lot codes: HSI
- 2) 96-2353
- UDI/DI 50649111397996
- Lot codes: SK-130
- 3) 96-2355A
- UDI/DI 50649111488144
- 4) 96-2356A
- UDI/DI 50649111488137
- 5) 96-2358A
- UDI/DI 50649111488168
- 6) 96-2417
- UDI/DI 50649111440272
- 7) 96-2580
- UDI/DI 50649111062696
- Lot codes: FSF12
- FSF13
- FSF17
- FSF20
Distribution
Distributed nationwide across the United States.
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