Data Foundry

Medical device recalls 2016

Ossur Lil Angel Vest P2 Lambswool — Class II medical device recall Z-1511-2016

Terminated recall by Ossur H / F, reported 2016-04-27, distributed nationwide. There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

Recall numberZ-1511-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmOssur H / F, Reykjavik, N/A, Iceland
Recall initiated2016-03-14
Classified2016-04-19
Reported by FDA2016-04-27
Terminated2016-08-16
DistributedNationwide (US)
Countries outside the USHK
Quantity435 all
Reason classesdevice malfunction

Product

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.

Reason for recall

There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1511-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.