Dynarex CPR Shield Recalled for Incorrect Orientation Labeling
Dynarex Corporation is recalling CPR Shields with One Way Valves because the 'THIS SIDE UP' label is on the wrong side, posing a potential health hazard if misused.
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 describes a labeling error that poses a 'potential' hazard without reporting any actual illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Dynarex Corporation is recalling CPR Shields With One Way Valve and Barrier Filter, Reorder No. 4921. The product is manufactured for Dynarex Corporation and made in China. It is used as a physical barrier for mouth-to-mouth resuscitation.
The recall was initiated because the 'THIS SIDE UP' label is printed on the wrong side of the product. The source text states that this labeling error poses a potential health hazard if the wrong labeling is followed by caregivers.
The recall affects 208 domestic cases and 42 foreign cases, distributed worldwide in the USA, Canada, and Mexico. The affected lot numbers are 28619 and 28621. Consumers should stop using the product and contact Dynarex Corporation for instructions on how to proceed.
The recalled product
- Product
- CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
- Manufacturer
- Dynarex Corporation
- 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 Numbers 28619 & 28621
Distribution
Distribution scope not specified by the agency.
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