CooperSurgical Recalls Milex Arcing Diaphragms Due to Incorrect Size
CooperSurgical, Inc. is recalling two units of Milex Arcing Diaphragms (Model MXWS95) because they contain an incorrect size diaphragm.
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 involves a situation that could cause temporary or medically reversible health consequences. The defect is a sizing error, and no injuries or illnesses are reported in the source text.
Plain-English summary
CooperSurgical, Inc. is recalling two units of the Milex Arcing Diaphragm, Size 95, Model Number MXWS95. The recall was initiated because the products were identified to contain an incorrect size diaphragm.
The affected units are from Lot # 130438. These products were distributed in the United States to the states of Oregon and New York.
Consumers and healthcare providers who have these specific units should stop using them and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Milex Arcing Diaphragm Size 95; Model Number: MXWS95
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 2
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)
- Lot# 130438
Distribution
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