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.
What this means for you
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
Same manufacturer · Stradis Healthcare, LLC.
See all →- ModerateStradis Hand Pack Recall Due to Medtronic Glove Component Issue
FDA (Devices) · 2015-07-15
- ModerateStradis ENT Packs Recalled Due to Medtronic Glove Component Recall
FDA (Devices) · 2015-07-15
- ModerateStradis Blepharoplasty Packs Recalled Due to Component Recall
FDA (Devices) · 2015-07-15
- HighStradis Arthroscopy Packs Recalled Due to Component Recall
FDA (Devices) · 2015-07-15
- ModerateStradis Healthcare Recalls Surgical Set Up Packs Containing Recalled Devon Light Gloves
FDA (Devices) · 2015-07-15
Same hazard · component recall
See all →- HighAnesthesia sets recalled because they contain recalled leaking Clearlink IV sets
FDA (Devices) · 2025-10-22
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringes
FDA (Devices) · 2024-09-04