CooperSurgical Recalls ICSI Micropipettes Due to Missing Bend
CooperSurgical is recalling 480 ICSI Micropipettes because the required thirty-degree bend is absent. The affected units were distributed in Denmark, Italy, and Sweden.
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 defect is a structural deviation (missing bend) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CooperSurgical, Inc. is recalling 480 units of ICSI Micropipettes, part number MICC001-30-B1.0, under FDA recall number Z-1367-2019. The recall was initiated because the thirty-degree bend is absent from the product.
The affected units are identified by Lot 1557. These products were distributed in Denmark, Italy, and Sweden.
Consumers and healthcare providers should stop using the affected micropipettes and contact CooperSurgical for instructions on return or replacement.
The recalled product
- Product
- ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 480
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 1557
Distribution
Distribution scope not specified by the agency.
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