Angio Pack surgical trays recalled for incomplete sealing and sterility breach
Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device where manufacturing defects may compromise product sterility. No illnesses, injuries, or deaths have been reported. The hazard represents a risk to patient safety if sterile integrity is lost, meeting the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stradis Healthcare is recalling Angio Pack surgical procedure trays (Item No. 686-199, lot number 22236491017) due to manufacturing defects. The outer bag of the tray may be incompletely sealed, which could compromise the sterility of the kit—a critical requirement for safe use in medical and surgical procedures.
The affected Angio Packs were distributed nationwide in the United States and Canada. The recall involves units with UDI codes M7526861991 (case) and M7526861990 (kit). No illnesses or injuries have been reported to date.
The recalled product
- Product
- STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 24
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 (3)
- UDI/DI (case) M7526861991
- UDI/DI (kit)M7526861990
- Serial/Lot Numbers: 22236491017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare 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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