Cypress Medical Products Recalls Skin Staple Remover Kits Due to Iodine Levels
Cypress Medical Products LLC is recalling specific surgical kits because they do not meet iodine assay requirements for their 36-month expiration dating.
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, which typically corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Cypress Medical Products LLC is recalling the 241-McKesson Premium Skin Staple Remover Kit, Item #100123 McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products Skin Staple Remover Kit. The recall involves 12,206 cases of these manual surgical instruments.
The products are being recalled because they do not meet the iodine assay level requirements necessary to support a 36-month expiration dating. This is a Class II recall, indicating that use of or exposure to the product might cause temporary or medically reversible adverse health consequences.
The affected products were distributed in the United States to the states of Colorado, Florida, Georgia, Kentucky, Michigan, Missouri, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Washington, and Wisconsin. Consumers and healthcare facilities should stop using these specific items and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products Skin Staple Remover Kit. McKesson Item # 241, 100123, and 100124, Cypress Item # 82-15 Manual surgical instrument for…
- Manufacturer
- Cypress Medical Products LLC
- Hazard
- Affected units
- 12,206
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 (4)
- Item 241
- 100123
- 100124
- 82-15
Distribution
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