Surgical Blade Safety Cartridges Recalled Due to Missing Sterilization
Southmedic is recalling 450 units of sterile surgical blade cartridges (Lot W92761) because the product was not sterilized but was labeled and distributed as sterile. Non-sterile surgical blades could cause infection if used on patients.
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: This is an FDA Class II medical device recall involving a risk-of-harm product (non-sterile surgical instrument) with no reported injuries or illnesses, meeting the rubric criterion for Score 3 (High): 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Southmedic, Inc. is recalling 450 units of Southmedic Safety Cartridge with Southmedic Plus Surgical Blade (GTIN 620974002628, Lot W92761). The affected product was distributed in Illinois.
The company identified that Lot W92761 was not sent out for sterilization as required. Instead, the product was transferred directly to distribution and sold to customers with sterile labeling, despite being non-sterile. Using a non-sterile surgical blade in medical procedures could result in patient infection.
This recall affects customers who purchased this product for medical use in Illinois. Healthcare facilities and medical professionals who received this lot should stop using it immediately.
Customers who have this product should stop using it and contact Southmedic for instructions on return or replacement with a properly sterilized unit.
The recalled product
- Product
- Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
- Manufacturer
- Southmedic, Inc.
- Affected units
- 450
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 (2)
- GTIN 620974002628
- Lot number: W92761
Distribution
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