The Recall Desk
ModerateFDA (Devices)·Z-1239-2015·Announced 2015-03-11

CooperSurgical Pessary Kit Recalled for Incorrect Size Labeling

CooperSurgical is recalling 95 units of Pessary Kit-CUBE#2 because the packaging label displays the incorrect size.

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, and the hazard is a minor labeling error regarding product size, which fits the criteria for a moderate severity recall.

Plain-English summary

CooperSurgical, Inc. is recalling 95 units of the Pessary Kit-CUBE#2, 1-3/8 in, 35 mm (Part Number: MXKPEC02). The recall is due to an incorrect size being printed on the packaging label.

The affected products were distributed nationwide. The specific lot numbers involved are 144351 and 142789.

Consumers who have this product should check the packaging label for the incorrect size and contact the manufacturer for instructions on how to proceed.

The recalled product

Product
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
Affected units
95

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 (2)

  • Lot numbers: 144351
  • 142789

Distribution

Distributed nationwide across the United States.