Stradis Healthcare Recalls General Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling General Packs that contain Devon Light Gloves. The recall is necessary because the glove manufacturer, Medtronic, is recalling the specific 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: This is a Class II recall involving a surgical component. The source text does not report any illnesses, injuries, or deaths, and the hazard is derived from the component manufacturer's recall rather than a specific reported safety failure in the kit itself.
Plain-English summary
Stradis Healthcare, LLC. is recalling General Packs that contain Devon Light Gloves. These packs are used during surgery. The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, is recalling the gloves.
The affected product is identified as Pack 670-115. The distribution pattern includes the United States nationwide to specific states, as well as Canada and Dubai.
Consumers and healthcare facilities should stop using these General Packs and contact Stradis Healthcare for further instructions regarding the recall.
The recalled product
- Product
- General Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- 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 670-115
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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