Stradis Standard Pack Recalled Due to Medtronic Component Recall
Stradis Healthcare is recalling Standard Packs containing Devon Light Gloves because the glove component was recalled 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 medical device component. The source text does not report any illnesses, injuries, or deaths, and the hazard is derived from the upstream component recall rather than a direct reported safety incident, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Standard 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, has recalled that specific component.
The affected product is identified by the code Pack 681-022A. The distribution pattern for these products includes nationwide distribution in the United States to specific states, as well as Canada and Dubai. The source text does not specify the exact number of units recalled or the specific dates of distribution.
Consumers and healthcare facilities should stop using the affected Standard Packs and contact Stradis Healthcare or Medtronic for further instructions regarding the recall of the Devon Light Glove component.
The recalled product
- Product
- Standard 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 681-022A
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
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