Stradis Breast Augmentation Kits Recalled Due to Component Recall
Stradis Healthcare is recalling breast augmentation kits because they contain Devon Light Gloves, which are being recalled by the manufacturer 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: This is a Class II recall involving a component recall without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary action.
Plain-English summary
Stradis Healthcare, LLC. is recalling 24 units of Breast Augmentation Packs and Breast Augmentation Expanded Packs. These kits are used during surgery and contain Devon Light Gloves.
The recall is being conducted because the manufacturer of the Devon Light Gloves, Medtronic, is recalling that specific component. The affected packs were distributed nationwide in the United States to specific states, as well as to Canada and Dubai.
Consumers and healthcare facilities should stop using these kits and contact Stradis Healthcare for instructions on how to return the product.
The recalled product
- Product
- Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 24
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 (7)
- Pack 681-502
- 693-177
- 681-243
- 681-502
- 693-158
- 682-502
- 681-503
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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