Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture
Ossur H / F is recalling Lil Angel Vest P3 Kodel units due to a potential for partial or complete fracture of the plastic stabilizer strap.
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 structural defect in a medical device used for cervical spine traction, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Ossur H / F is recalling the Ossur Lil Angel Vest P3 Kodel, a pediatric-sized support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. The recall involves 435 units of all models, specifically identified by part number 545150K, manufactured from 2008 to the current date.
The recall was initiated because there is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. This defect could compromise the structural integrity of the device used for cervical spine traction.
The affected products were distributed nationwide in the United States and in Hong Kong. Consumers and healthcare providers should stop using the recalled vests and contact the recalling firm for further instructions.
The recalled product
- Product
- Ossur Lil Angel Vest P3 Kodel. 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
- Hazard
- 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: 545150K 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.
See all 6 products in this recall →Related recalls
Same manufacturer · Ossur H / F
See all →- HighMiami J Select Collar Recalled Due to Adhesive Failure
FDA (Devices) · 2024-10-09
- HighProsthetic knee recalled due to firmware defect causing device shutdown
FDA (Devices) · 2024-05-22
- HighProsthetic Knee Firmware Defect Risks Unintended Shutdown and Patient Falls
FDA (Devices) · 2024-05-22
- HighProsthetic knee recalled due to firmware issues causing potential device shutdown
FDA (Devices) · 2024-05-22
- HighOssur RHEO Knee XC Prosthetic Components Recall Due to Firmware Issues
FDA (Devices) · 2024-05-22
Same hazard · structural failure
See all →- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
- SevereRing Power Recalls Terex Vehicles Due to Potential Pintle Hitch Failure
NHTSA · 2026-10-02
Similar recalls
- ModerateOssur LIL Angel Vest Recalled for Labeling and Safety Testing Issues
FDA (Devices) · 2019-03-20
- ModerateOssur ReSolve Halo Vest Recalled for Labeling and Safety Testing Issues
FDA (Devices) · 2019-03-20
- SevereOssur LP Rotate Foot System Recalled for Insecure Assembly
FDA (Devices) · 2015-03-25
- HighOssur Recalls Rebound Air Walkers and Other Medical Devices
FDA (Devices) · 2016-04-06
- HighOssur Recalls Multiple Medical Devices Including Miami J Collars
FDA (Devices) · 2016-04-06
- HighOssur Recalls Multiple Medical Devices Including Back Support Suspenders
FDA (Devices) · 2016-04-06