Stradis Tummy Tuck Pack Recalled Due to Component Defect
Stradis Healthcare is recalling Tummy Tuck Packs because they contain a Devon Light Glove component that is subject to a separate recall by Medtronic.
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 a precautionary measure triggered by a component recall (Devon Light Glove) without specific reports of injury or illness in the source text, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling one unit of the Tummy Tuck Pack, which contains a Devon Light Glove used during surgery. The recall is being conducted because the manufacturer of the glove component, Medtronic, is recalling the Devon Light Glove.
The affected product, identified by Pack 693-223, was distributed nationwide to specific US 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 recalled Tummy Tuck Packs and contact Stradis Healthcare for instructions on how to return or dispose of the product.
The recalled product
- Product
- Tummy Tuck 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 693-223
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.
See all 51 products in this recall →Related recalls
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