Stradis ENT Packs Recalled Due to Medtronic Glove Component Recall
Stradis Healthcare is recalling ENT Packs containing Devon Light Gloves due to a manufacturer recall of the 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: The recall is a precautionary measure driven by a component recall from the manufacturer (Medtronic) without explicit reports of injury or illness in the source text, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling ENT 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 products are identified by pack codes 888-2352 and 888-2434. The distribution pattern indicates the products were distributed nationwide in the United States to specific states, as well as to Canada and Dubai. The source text does not specify the total number of units recalled or the specific dates of distribution.
Consumers and healthcare facilities should stop using these ENT Packs and contact Stradis Healthcare or Medtronic for further instructions regarding the recall of the Devon Light Glove component.
The recalled product
- Product
- ENT Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 2
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 (2)
- Pack 888-2352
- 888-2434
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.
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