Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1995-2015·Announced 2015-07-15

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.

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 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: component-recall
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

Distributed nationwide across the United States.

The notice also names 33 states specifically:

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 →

Same manufacturer · Stradis Healthcare, LLC.

See all →

Moderate
Stradis Hand Pack Recall Due to Medtronic Glove Component Issue
FDA (Devices) · 2015-07-15
Moderate
Stradis ENT Packs Recalled Due to Medtronic Glove Component Recall
FDA (Devices) · 2015-07-15
Moderate
Stradis Blepharoplasty Packs Recalled Due to Component Recall
FDA (Devices) · 2015-07-15
High
Stradis Arthroscopy Packs Recalled Due to Component Recall
FDA (Devices) · 2015-07-15
Moderate
Stradis Healthcare Recalls Surgical Set Up Packs Containing Recalled Devon Light Gloves
FDA (Devices) · 2015-07-15

Same hazard · component recall