Stradis Healthcare Recalls Lipo Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling Lipo Packs, Expended Packs, and Trays because they contain Devon Light Gloves that Medtronic is recalling.
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 action taken because a component (Devon Light Glove) is being recalled by its manufacturer. The source text does not report any illnesses, injuries, or specific defects, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling 13 units of Lipo Pack, Liposuction Expended Pack, and Liposuction Tray products. These convenience kits are being recalled because they contain a component, the Devon Light Glove, which is subject to a separate recall by its manufacturer, Medtronic.
The affected products 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 products were also distributed to Canada and Dubai.
The specific product codes involved are 681-025, 681-268, 681-254, 681-013, 681-506, and 888-2587. The source text does not specify the exact nature of the defect in the Devon Light Glove or the specific health risks associated with its use. Consumers and healthcare providers should stop using these kits and contact Stradis Healthcare or Medtronic for further instructions regarding the component recall.
The recalled product
- Product
- Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 13
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 (6)
- Pack 681-025
- 681-268
- 681-254
- 681-013
- 681-506
- 888-2587
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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