Ossur LIL Angel Vest Recalled for Labeling and Safety Testing Issues
Ossur Americas is recalling 45 LIL Angel Vests because the titanium pin labels incorrectly list ceramic tips and require confirmatory safety testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error and confirmatory safety testing, which aligns with the rubric for moderate severity involving minor labeling errors or precautionary measures.
Plain-English summary
Ossur Americas is recalling 45 units of the LIL Angel Vest, including P2 and P3 models in Kodel, Lambswool, and Sorbex materials. The recall covers all lots of these products manufactured between June 30, 2009, and December 13, 2018.
The recall was initiated because the second line of the description on the titanium pin labels mistakenly lists "ceramic tip" instead of "titanium pin." Additionally, Halo system products labeled as MR conditional are undergoing confirmatory safety testing to verify their MR conditional parameters.
The affected products were distributed in the United States and in Australia, Germany, New Zealand, and Belgium. Consumers should stop using the affected vests and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX
- Manufacturer
- Ossur Americas
- Affected units
- 45
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)
- All lots of the products manufactured from 06/30/2009 - 12/13/2018
Distribution
Part of a larger recall action
This product is one of 8 recalled by Ossur Americas 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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