Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture
Ossur H / F is recalling Lil Angel Vest P3 Lambswool units because the plastic stabilizer strap may fracture. The recall covers 435 units distributed in the US and Hong Kong.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (fracture) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ossur H / F is recalling the Ossur Lil Angel Vest P3 Lambswool, a pediatric-sized support structure used with the halo system for cervical spine traction. The recall involves 435 total units across all models, specifically those with part number 545150L manufactured from 2008 to the present.
The recall is being issued because there is a potential for the plastic stabilizer strap on the vest to partially or completely fracture. This product was distributed nationwide in the United States and in Hong Kong.
Consumers should stop using the affected vests immediately. The source text does not specify further consumer instructions or contact information for the recall.
The recalled product
- Product
- Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
- Manufacturer
- Ossur H / F
- Affected units
- 435
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)
- P/N: 545150L units from 2008 to current
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Ossur H / F under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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