Stryker Cub pediatric cribs sold in USA missing two warning labels
Stryker is recalling Cub Pediatric Cribs, model FL19H, because cribs sold in the USA are missing two access door warning labels.
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: Rubric level 2 covers minor labelling errors: the recall concerns two missing warning labels, and the source describes no defect in the crib itself.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling the Cub Pediatric Crib, model FL19H. About 590 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
Cribs sold in the USA are missing two access door warning labels. The source record does not describe a defect or malfunction in the crib itself.
Affected product carries UDI-DI 07613327169348, across the serial numbers listed in the FDA enforcement record.
Facilities can identify affected cribs by the model and serial numbers above, and may contact Stryker for further information.
The recalled product
- Product
- Cub Pediatric Crib, Model FL19H
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 590
Distribution
Distributed nationwide across the United States.
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