Stradis Vein Surgery Packs Recalled Due to Component Issue
Stradis Healthcare is recalling 55 vein surgery packs because they contain a Devon Light Glove component subject to a separate recall by Medtronic.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or specific hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling 55 units of Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, and Vein Ablation Pack. These convenience kits are used during surgery and contain a Devon Light Glove component.
The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, has issued a recall for that specific item. The source text does not specify the nature of the defect or hazard associated with the Devon Light Glove, nor does it report any illnesses or injuries.
The affected products were distributed nationwide in the United States to specific states, as well as to Canada and Dubai. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items, such as returning them or seeking refunds.
The recalled product
- Product
- Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 55
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 (20)
- Pack 682-949
- 682-937
- 682-900
- 682-370
- 682-218
- 682-1264
- 682-1529
- 682-076
- 682-192
- 682-962
- 682-968
- 682-177
- 682-394
- 682-988
- 682-156
- 682-063
- 682-151
- 682-917
- 682-250
- 682-409
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