Stradis Face Lift Pack Recalled Due to Component Defect
Stradis Healthcare is recalling Face Lift Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
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 2/5 (Moderate).
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 is a precautionary measure triggered by a component recall, with no specific injuries or illnesses reported in the source text.
Plain-English summary
Stradis Healthcare, LLC. is recalling Face Lift Packs that contain Devon Light Gloves. These convenience kits are used during surgery. The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, has recalled the gloves.
The affected product is identified by Pack 888-2532. The kits were distributed nationwide in the United States to specific states including Alabama, Alaska, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Mexico, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington. The product was also distributed to Canada and Dubai.
Consumers and healthcare facilities should stop using the affected Face Lift Packs and contact Stradis Healthcare for further instructions regarding the recall.
The recalled product
- Product
- Face Lift Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 1
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 888-2532
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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