Myco Medical Recalls Technocut Plus Safety Scalpels Due to Sterility Concerns
Myco Medical is recalling Technocut Plus safety scalpels due to labeling errors and defective packaging that may compromise sterility.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the source text describes labeling and packaging defects that may compromise sterility without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Myco Medical Supplies Inc is recalling 110,768 Technocut Plus, Sterile Single Use Safety Scalpels. The recall is due to pouch labeling and printing errors, as well as defective packaging that may result in compromised sterility.
The affected products were distributed worldwide, including in the United States (California, Florida, Illinois, Michigan, Missouri, New York, Ohio, Pennsylvania, South Carolina, Tennessee, and Wisconsin) and Canada. The specific catalogue numbers involved are 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, and 6008TR-20, with batch numbers ranging from 1208235 to 1212052.
Healthcare facilities and consumers should stop using these scalpels and contact Myco Medical Supplies Inc for instructions on return or replacement.
The recalled product
- Product
- Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
- Manufacturer
- Myco Medical Supplies Inc
- Affected units
- 110,768
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 (17)
- Catalogue number: 6008TR-10
- 6008TR-11
- 6008TR-12
- 6008TR-15
- 6008TR-20
- Batch numbers: 1208235
- 1210189
- 1211305
- 1208276
- 1211213
- 1208224
- 1210105
- 1212041
- 1208307
- 1211192
- 1212052
- 1210116.
Distribution
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