Stradis ACL Pack Recalled Due to Component Glove Recall
Stradis Healthcare is recalling ACL Packs containing Devon Light Gloves because the manufacturer, Medtronic, is recalling 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 Class II recall driven by a component recall without reported injuries or illnesses in the source text, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Stradis Healthcare, LLC. is recalling ACL Packs that contain Devon Light Gloves. These convenience kits are used during surgery. The recall is being conducted because the manufacturer of the component, Medtronic, is recalling the Devon Light Gloves.
The affected product is identified by Pack 693-055. The distribution pattern includes the United States nationwide 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 Canada and Dubai.
The source text does not specify specific actions for consumers or healthcare providers beyond the fact that the kits are being recalled due to the component recall.
The recalled product
- Product
- ACL Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- 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 693-055
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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