Sklar Instruments iris hooks recalled for sterile packaging integrity issues
Sklar Instruments is recalling ECONO STERILE iris hook surgical kits due to packaging defects that may compromise sterile barrier integrity. No injuries reported.
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 involving potential sterile barrier breach on surgical instruments used in high-risk eye procedures. No reported illnesses or injuries; the hazard is theoretical contamination. Classified as High per rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25 medical procedure kits (Model 96-2224A) due to reports of packaging issues that may result in a breach of the sterile barrier.
The affected kits were distributed nationwide. The recall involves 25-unit packages identified by lot code HSI and UDI/DI 50649111487932.
If the sterile barrier is compromised, the surgical instruments may become contaminated with bacteria or fungi. These kits are used in eye surgery, where sterile conditions are essential. No illnesses or injuries have been reported.
Healthcare facilities and surgical centers with affected kits should discontinue use immediately and contact Sklar Instruments for replacement or return instructions.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
- 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)
- 96-2224A
- UDI/DI 50649111487932
- Lot codes: HSI
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.
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