Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2028-2015·Announced 2015-07-15

Stradis Hand Pack Recall Due to Medtronic Glove Component Issue

Stradis Healthcare is recalling Hand Packs containing Devon Light Gloves due to a manufacturer recall of the glove component 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: This is a Class II recall involving a component recall by the manufacturer without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary action.

Plain-English summary

Stradis Healthcare, LLC. is recalling Hand Packs that contain Devon Light Gloves used during surgery. The recall is being conducted because the manufacturer of the glove component, Medtronic, is recalling the Devon Light Glove.

The affected products are identified by pack codes 888-2376, 888-2397, 888-2414, and 888-2471. The quantity involved is 4 units. These products were distributed nationwide in the United States to specific states including Alabama, Alaska, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Mexico, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington. Distribution also extended to Canada and Dubai.

Healthcare facilities and consumers should stop using these Hand Packs and contact Stradis Healthcare or Medtronic for instructions on how to return or dispose of the affected products.

The recalled product

Product: Hand Pack - contains Devon Light Glove Used during surgery
Manufacturer: Stradis Healthcare, LLC.
Category: Medical Device — Surgical Gloves
Hazard: component-recall
Affected units: 4

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 (4)

Pack 888-2376
888-2397
888-2414
888-2471

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 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
Moderate
Stradis Surgical Packs Recalled Due to Medtronic Glove Component Issue
FDA (Devices) · 2015-07-15

Same hazard · component recall