The Recall Desk
ModerateFDA (Devices)·Z-2498-2020·Announced 2020-07-15

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.

What this means for you

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

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.