Medical procedure trays recalled for incomplete outer bag sealing
Stradis Medical recalls Henry Schein temp stimulator supplies due to incomplete outer bag sealing that may compromise kit sterility. Affected units should not be used until reviewed.
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 a Class II FDA recall of medical devices with potential sterility compromise due to incomplete sealing. No illnesses or injuries have been reported, and the hazard is theoretical risk of sterility breach rather than confirmed harm. The score reflects the risk-of-harm nature of surgical procedure trays combined with the absence of reported adverse events.
Plain-English summary
Henry Schein Temp Stimulator Supplies (Item No. 570-2883) manufactured by Stradis Medical, LLC dba Stradis Healthcare are being recalled due to manufacturing defects that may result in incompletely sealed outer bags on medical and surgical procedure trays and kits.
An incomplete seal on the outer bag may compromise the sterility of the kit, creating a potential risk if the products are used without verification of seal integrity.
This recall affects units distributed nationwide in the United States and Canada, with lot/serial number 22229489323 identified in the recall notice.
Healthcare facilities and users in possession of affected units should stop use and contact Stradis Medical, LLC or Henry Schein directly for guidance on the recall and replacement procedures.
The recalled product
- Product
- HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
- 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) H65857028831
- UDI/DI (kit)M75257028831
- Serial/Lot Numbers: 22229489323
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
- HighCenturion Medical Products Recalls Surgical Trays Due to Incomplete Seals
FDA (Devices) · 2020-02-12
- HighSurgical Instrument Trays Recalled for Compromised Outer Bag Sterility
FDA (Devices) · 2023-02-22
- HighCystoscopy kits recalled for potential sterility breach from packaging defects
FDA (Devices) · 2023-01-18
- HighSurgical convenience kits recalled for compromised sterility packaging
FDA (Devices) · 2023-02-22
- HighSurgical kit recall due to outer bag perforation and sterility risk
FDA (Devices) · 2022-04-13