CooperSurgical Recalls Mislabeled Os Finder Cervical Dilators
CooperSurgical is recalling 2,250 Os Finder Cervical Dilators due to mislabeled blister trays. The product inside is correct, but the packaging label is incorrect.
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 explicitly states the product inside is correct and the issue is limited to packaging labeling, fitting the 'Minor labeling errors' criterion for a Moderate score.
Plain-English summary
CooperSurgical, Inc. is recalling 2,250 units (45 boxes of 50) of the Os FinderTM Cervical Dilator, Part Number 1176. The recall is due to a labeling error on the individual product blister trays. The printing on the top web or Tyvek lid of the blister tray incorrectly indicates that the package contains a Pipet Current or Part Number MX140, while the display box correctly identifies the Os FinderTM Cervical Dilators.
The source text confirms that the product inside the individual package is the correct Os Finder Cervical Dilator. The recall is limited to Lot 284288, which has an expiration date of 02/24/2023. The affected units were distributed nationwide.
Healthcare providers and consumers should check their inventory for this specific lot number and part number. If the product is found, it should be returned to the supplier or the manufacturer for credit. The FDA has classified this as a Class II recall.
The recalled product
- Product
- COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
- Manufacturer
- CooperSurgical, Inc.
- 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)
- Lot 284288 - Expiration date: 02/24/2023
Distribution
Distributed nationwide across the United States.
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