Stradis Blepharoplasty Packs Recalled Due to Component Recall
Stradis Healthcare is recalling Blepharoplasty Packs because they contain Devon Light Gloves, which are 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 illnesses, injuries, or specific hazards, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Stradis Healthcare, LLC. is recalling Blepharoplasty Packs (Pack 888-2533) because they contain a component, the Devon Light Glove, that is being recalled by its manufacturer, Medtronic. These packs are used during surgery.
The recall is a direct result of the manufacturer's recall of the gloves contained within the kits. The source text does not specify the nature of the defect in the gloves or any associated health risks.
The affected products were distributed nationwide in the United States to specific states including AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, and WA, as well as to Canada and Dubai. The source text does not provide instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- Blepharoplasty Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 1
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 888-2533
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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