openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 6
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.
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Code information
P/N: 545100K units from 2008 to current
Distribution pattern
Distribution US Nationwide and Hong Kong
device · product 2 of 6
Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Code information
P/N: 545100L units from 2008 to current
Distribution pattern
Distribution US Nationwide and Hong Kong
device · product 3 of 6
Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Code information
P/N: 545100S units from 2008 to current
Distribution pattern
Distribution US Nationwide and Hong Kong
device · product 4 of 6
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.
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Code information
P/N: 545150K units from 2008 to current
Distribution pattern
Distribution US Nationwide and Hong Kong
device · product 5 of 6
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.
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Code information
P/N: 545150L units from 2008 to current
Distribution pattern
Distribution US Nationwide and Hong Kong
device · product 6 of 6
Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
