Cardinal Health Recalls Gomco Style Circumcision Clamp Trays Due to Labeling Error
Cardinal Health is recalling Gomco Style Circumcision Clamp Trays because two lots were labeled as containing 1.1cm clamps but actually contained 1.3cm clamps.
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, but the source text describes a labeling error regarding clamp size without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for minor labeling errors or low-risk issues where harm has not been reported.
Plain-English summary
Cardinal Health is recalling Gomco Style Circumcision Clamp Trays, which are instruments used to compress the foreskin of the penis during circumcision of a male infant. The recall involves two specific lots: SSI-0034 (380 units) and 10-1100 (60 units). The affected lots were distributed nationwide, including in Arkansas, Kansas, West Virginia, North Carolina, Texas, Alabama, Mississippi, and Virginia.
The reason for the recall is a labeling discrepancy. The affected trays were labeled as containing a 1.1cm circumcision clamp, but they actually contained a 1.3cm clamp. The specific lot numbers involved are 462799 and 476803 for SSI-0034, and 462788 and 485406 for 10-1100.
Healthcare providers and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the supplier or Cardinal Health for further instructions. This recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
- Manufacturer
- Cardinal Health
- Hazard
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)
- SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406
Distribution
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