Stradis Healthcare Recalls Shoulder Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling surgical shoulder packs because they contain Devon Light Gloves that are subject to a separate manufacturer 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 a precautionary action taken because a component is subject to a separate recall. The source text does not report any injuries, illnesses, or specific hazards, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling one lot of Shoulder Packs used during surgery. The recall is necessary because the packs contain Devon Light Gloves, which are subject to a separate recall by the manufacturer, Medtronic.
The affected product is identified by Pack 888-2349. The distribution pattern includes the United States (specifically 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, WA), Canada, and Dubai.
The source text does not specify the exact nature of the defect in the Devon Light Gloves or report any specific injuries or illnesses. Consumers and healthcare facilities should check their inventory for the specific pack code and stop using the product if it matches the recalled lot.
The recalled product
- Product
- Shoulder 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 888-2349
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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