Ethicon Recalls PERMA-HAND Silk Sutures Due to Labeling Mismatch
Ethicon is recalling 840 units of PERMA-HAND Silk Sutures because the product inside the packaging does not match the size or type indicated on the label.
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 a labeling mismatch without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving labeling errors or low-risk contamination.
Plain-English summary
Ethicon, Inc. is recalling 840 units of PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T, Lot MEH906. The recall was initiated because the sutures inside the packaging are not the same size or type as indicated on the label.
The affected products were distributed to the following US states: AR, CA, FL, GA, KS, LA, MO, MS, ND, NE, NJ, NY, OH, PA, and WI. The sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
Healthcare providers and facilities should stop using the affected sutures and contact Ethicon for further instructions. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 840
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)
- Product Lot MEH906
Distribution
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