Stradis Lima Pack Surgical Kits Recalled Due to Component Issue
Stradis Healthcare is recalling Lima Pack surgical kits because they contain a Devon Light Glove component that Medtronic is recalling.
What this means for you
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). The source text does not report any illnesses, injuries, or deaths, and the hazard is theoretical pending the resolution of the component issue.
Plain-English summary
Stradis Healthcare, LLC. is recalling Lima Pack surgical kits. These kits are used during surgery and contain a Devon Light Glove component. The recall is being conducted because the manufacturer of the component, Medtronic, is recalling the Devon Light Glove.
The affected product is identified by Pack 682-927. The kits 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 kits were also distributed to Canada and Dubai.
Consumers and healthcare facilities should stop using the affected Lima Pack kits and contact Stradis Healthcare for instructions on how to return or dispose of the product.
The recalled product
- Product
- Lima Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 2
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 682-927
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
Same manufacturer · Stradis Healthcare, LLC.
See all →- ModerateStradis Hand Pack Recall Due to Medtronic Glove Component Issue
FDA (Devices) · 2015-07-15
- ModerateStradis ENT Packs Recalled Due to Medtronic Glove Component Recall
FDA (Devices) · 2015-07-15
- ModerateStradis Blepharoplasty Packs Recalled Due to Component Recall
FDA (Devices) · 2015-07-15
- HighStradis Arthroscopy Packs Recalled Due to Component Recall
FDA (Devices) · 2015-07-15
- ModerateStradis Healthcare Recalls Surgical Set Up Packs Containing Recalled Devon Light Gloves
FDA (Devices) · 2015-07-15
Same hazard · component recall
See all →- HighAnesthesia sets recalled because they contain recalled leaking Clearlink IV sets
FDA (Devices) · 2025-10-22
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringes
FDA (Devices) · 2024-09-04