Surgical Procedure Trays Recalled Over Incomplete Outer Bag Seals
Stradis Medical is recalling surgical procedure trays due to manufacturing defects that may leave outer bags incompletely sealed, potentially breaching kit sterility. No illnesses have been reported.
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 involving surgical procedure kits with a potential sterility breach hazard. The rubric classification of 'risk-of-harm products where injury has not yet been reported' applies: sterile surgical instruments are critical to prevent infection, but no illnesses or injuries have been reported and the hazard is theoretical rather than confirmed.
Plain-English summary
Stradis Medical, LLC (dba Stradis Healthcare) is recalling medical and surgical procedure trays and kits marketed as HENRY SCHEIN Vas Pack, Item No. 888-2520. The recall affects 304 units distributed nationwide in the United States and Canada (lot number 22256490684).
Certain manufacturing conditions resulted in incomplete sealing of the outer bag on these kits. An incomplete seal may allow the sterile contents to be compromised before the kit is opened for use.
Healthcare facilities and professionals who have these kits should stop using them and contact Stradis Healthcare for return or replacement instructions. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- HENRY SCHEIN, Vas Pack, Item No.888-2520,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 304
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) H65888825201
- UDI/DI (kit)M75288825200
- Serial/Lot Numbers: 22256490684
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.
See all 78 products in this recall →Related recalls
Same manufacturer · Stradis Medical, LLC dba Stradis Healthcare
See all →- HighStradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2022-12-21
- HighGeneral Surgery Procedure Kit Recalled for Sterility Concerns
FDA (Devices) · 2022-12-21
- HighStradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal
FDA (Devices) · 2022-12-21
- HighSurgical Procedure Trays Recalled for Potential Sterility Breach
FDA (Devices) · 2022-12-21
- HighSurgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect
FDA (Devices) · 2022-12-21
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighPHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
FDA (Devices) · 2023-01-18
- HighSurgical kit recall due to outer bag perforation and sterility risk
FDA (Devices) · 2022-04-13
- HighNeurological surgical kits may have compromised packaging sterility
FDA (Devices) · 2022-04-13
- HighTotal Knee Surgical Kit Recall Due to Potential Sterility Breach
FDA (Devices) · 2022-04-13
- HighAnterior Hip Surgical Kit Recall Due to Potential Sterility Breach
FDA (Devices) · 2022-04-13
- HighCenturion Medical Products Recalls Surgical Trays Due to Incomplete Seals
FDA (Devices) · 2020-02-12