Southmedic Recalls Sterile Scalpels Labeled as Non-Sterile
Southmedic, Inc. is recalling 3,300 sterile disposable scalpels because the product contains non-sterile items labeled as sterile.
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: The recall involves a medical device where the sterility assurance is compromised. While no injuries are reported, using non-sterile devices in medical procedures presents a significant risk of harm, fitting the 'risk-of-harm products where injury has not yet been reported' criterion for High severity.
Plain-English summary
Southmedic, Inc. has initiated a recall of its Sterile Disposable Scalpel (Rx only). The affected units are intended for use in various medical procedures for the preparation, scraping, and cutting of tissue.
The recall is necessary because the lot contains non-sterile products that were incorrectly labeled as sterile. This discrepancy poses a risk to patients who may rely on the sterility of the device for safe medical use.
The recalled product includes 3,300 scalpels with Part Number 73-0115 and Lot Number 092517. These units were distributed to Iowa, Illinois, Nebraska, New York, and Texas.
The recalled product
- Product
- Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
- Manufacturer
- Southmedic, Inc.
- Affected units
- 3,300
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 (1)
- Part Number 73-0115 Lot Number 092517
Distribution
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