Gf Health Products Recalls Drop Arm Versamode Due to Incorrect Casters
Gf Health Products is recalling 66 units of the Drop Arm Versamode because the front casters are incorrect. The devices were distributed in the US and internationally.
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, and the source text does not report any injuries, illnesses, or specific safety hazards beyond the incorrect component, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Gf Health Products is recalling 66 units of the Drop Arm Versamode (Model 6810A) because the front casters on the devices are incorrect. The affected devices are identified by Device Identifier M36868101 and Lot number BMW316BS.
The recalled products were distributed nationwide to California, Wisconsin, Pennsylvania, Illinois, and Texas, as well as internationally to Mexico and Canada.
The source text does not specify specific instructions for consumers or healthcare facilities regarding the next steps for this recall.
The recalled product
- Product
- Drop Arm Versamode"
- Manufacturer
- Gf Health Products
- Hazard
- Affected units
- 66
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 (3)
- Model: 6810A
- Device Identifier: M36868101
- and Lot number: BMW316BS
Distribution
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