Ossur Lil Angel Vest P2 Kodel Recalled for Potential Plastic Strap Fracture
Ossur H / F is recalling 435 Lil Angel Vest P2 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 medical device with a structural defect that could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ossur H / F is recalling 435 units of the Lil Angel Vest P2 Kodel, a pediatric-sized support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. The recall covers units with part number 545100K manufactured from 2008 to the current date.
The recall is being issued because there is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. The affected products were distributed nationwide in the United States and in Hong Kong.
Consumers should stop using the affected vests and contact the recalling firm for further instructions.
The recalled product
- Product
- Ossur Lil Angel Vest P2 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
- 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: 545100K 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 →- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
- Severe
- SevereRing Power Recalls Terex Vehicles Due to Potential Pintle Hitch Failure
NHTSA · 2026-10-02
- SevereKuat Pivot V3 Swing-Away Hitch Adapter Recall for Weld Cracking
NHTSA · 2026-10-01
- HighStarcraft Super Lite Maxx Travel Trailer Recall for Water Tank Fasteners
NHTSA · 2026-09-30
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
- ModerateOssur Halo System Ring Kits Recalled for Labeling and Safety Testing
FDA (Devices) · 2019-03-20
- ModerateStryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
FDA (Devices) · 2016-03-02
- HighOssur Recalls Rebound Air Walkers and Other Medical Devices
FDA (Devices) · 2016-04-06