Surgical procedure kit recalled due to incompletely sealed outer bag
A HENRY SCHEIN extremity pack surgical kit is being recalled because its outer bag may not be completely sealed, which could compromise the sterility of the kit. 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 medical device recall involving a sterility breach in surgical procedure trays—a risk-of-harm product used in invasive procedures. Although no illnesses or injuries have been reported, the potential for contamination during surgery represents a significant patient safety risk.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling HENRY SCHEIN EXTREMITY PACK surgical procedure trays and kits (Item No. 570-2946) due to a manufacturing defect. The outer bags of these kits may be incompletely sealed, which could result in a breach of the kit's sterility.
Sterile surgical procedure trays are intended to maintain the cleanliness and safety of medical instruments and materials used during procedures. If the outer bag seal is compromised, the kit may no longer be sterile and could pose a contamination risk during surgery or medical procedures.
The recall affects 144 units distributed nationwide in the United States and Canada. The affected lot is identified by Serial/Lot Number 22242490745. Facilities and medical providers who have received this product should contact the manufacturer or the FDA for further guidance on affected units and appropriate corrective actions.
The recalled product
- Product
- HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 144
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) H65857029461
- UDI/DI (kit)M75257029460
- Serial/Lot Numbers: 22242490745
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
- HighAnterior Hip Surgical Kit Recall Due to Potential Sterility Breach
FDA (Devices) · 2022-04-13
- 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
- HighPHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
FDA (Devices) · 2023-01-18
- HighSurgical convenience kits recalled for compromised sterility packaging
FDA (Devices) · 2023-02-22