Stradis Face Lift Pack Recalled Due to Component Recall
Stradis Healthcare is recalling Face Lift Packs because they contain a Devon Light Glove that is being recalled by its manufacturer, Medtronic.
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, which typically involves a temporary or medically reversible adverse health consequence. As no specific injuries, illnesses, or structural defects are reported in the source text, and it is a precautionary recall driven by a component recall, it fits the Moderate severity criteria.
Plain-English summary
Stradis Healthcare, LLC. is recalling one unit of the Face Lift Pack. This convenience kit is used during surgery and contains a Devon Light Glove. The recall is being conducted because the manufacturer of the glove, Medtronic, is recalling that specific component.
The affected product is identified by Pack 693-102. The distribution pattern indicates the product was distributed nationwide in the United States to specific states including AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, and WA. The product was also distributed to Canada and Dubai.
The source text does not specify the exact nature of the defect in the Devon Light Glove or provide instructions for consumers on how to dispose of or return the product. Users should refer to the official FDA recall notice for further details.
The recalled product
- Product
- Face Lift Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
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)
- Pack 693-102
Distribution
Part of a larger recall action
This product is one of 51 recalled by Stradis Healthcare, LLC. 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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