Stradis Surgical Packs Recalled Due to Medtronic Glove Component Issue
Stradis Healthcare is recalling surgical and general surgery packs because they contain Devon Light Gloves, a component being 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: The recall is a precautionary measure triggered by a component recall from the manufacturer (Medtronic) without specific reported injuries or illnesses in the source text, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Surgical Packs and General Surgery Packs. These kits are used during surgery and contain Devon Light Gloves. The recall is being conducted because the manufacturer of the gloves, Medtronic, is recalling the Devon Light Glove component.
The affected products are identified by the following codes: Pack 40604EBS, 693-152, 40759MMS, and 888-2371. The quantity involved is 4 units. The 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. The products were also distributed to Canada and Dubai.
Consumers and healthcare facilities should stop using these surgical packs and contact Stradis Healthcare, LLC. for further instructions regarding the recall.
The recalled product
- Product
- Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- 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 40604EBS
- 693-152
- 40759MMS
- 888-2371
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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