Sklar Instruments ECONO STERILE Blackhead Extractor Kits Recall
Sklar Instruments is recalling ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. The kits were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device with a potential sterile barrier breach. No reported illnesses or injuries are stated in the source. The hazard is a packaging defect that could allow contamination, which is a precautionary concern rather than a confirmed harm or high-risk pathogen.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25 blackhead extractor kits, Model Number 96-2395M (UDI/DI 50649111448896, Lot SK-133), distributed nationwide in packages of 25 units.
The recall is due to various packaging issues that may result in a breach of the sterile barrier. A compromised sterile barrier could allow contamination of the medical device.
Consumers who have purchased these kits should stop using them and contact Sklar Instruments or their supplier for instructions on return or replacement.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
- 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)
- 96-2395M
- UDI/DI 50649111448896
- Lot codes: SK-133
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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