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Product Recall  from XOTHRM

XOTHRM to make you aware of an issue currently under investigation involving certain SmartPad2 units:

  • XOTHRM has received two reports of SmartPad2 units exhibiting localized overheating within the heating assembly. Both incidents were reported on August 21, 2026. No injuries have been reported.

Note: This recall should be carried out between the customer and XOTHRM.

SmartPad2

What happened?
XOTHRM has received two reports of SmartPad2 units exhibiting localized overheating within the heating assembly. Both incidents were reported on August 21, 2026.

No injuries have been reported.

What is being done?
XOTHRM has received and evaluated both units. Their preliminary evaluation indicates that the visible discoloration resulted from localized heating within a specific area of the internal heating assembly.

They have identified the area where the localized heating occurred and are working directly with their heating assembly manufacturer and engineering partners to determine why it occurred and whether other units could be affected.

The root cause has not yet been determined.

Status : Monitor

Please review the instructions below and submit your response(s) and question(s) to XOTHRM support@xothrm.com

What To Do

Please take this precautionary step:

As a precaution, customers with SmartPad2 serial numbers 250000001 through 250001500 should temporarily stop using their SmartPad2 units until further notice.

Details:

The inclusion of a serial number within this range does not mean that the unit has experienced or will experience this condition. This range represents the population currently included in the precautionary stop-use notice while the investigation continues.

Please keep your SmartPad2 and do not dispose of, modify, open, or attempt to repair the device. There is no need to return your SmartPad2 at this time unless specifically instructed to do so.

XOTHRM recognizes that many customers recently participated in the SmartPad2 Upgrade Program. The condition currently under investigation is within the heating assembly installed during that program; however, it appears to be different from and unrelated to the issue that prompted the original upgrade.

XOTHRM has temporarily stopped shipments of potentially affected units, quarantined applicable inventory, and is working with its manufacturing and engineering partners to determine the root cause, potential scope, and appropriate next steps.

If your SmartPad2 has exhibited unusual heating, discoloration, a burn mark, unusual odor, melting, or any other unexpected heating behavior, do not use the unit and contact XOTHRM Customer Success at support@xothrm.com.

XOTHRM will provide additional information and instructions as soon as meaningful new information becomes available.


Affected Product and Lost List


  Expressaire Branded Sterile Tourniquet Cuff Products Affected Item Codes

Item CodePH SKUUDIAffected Lot Numbers
553322081082395(01) 00885914010532S0922STY, R0310STY, R0801STY, Q0930STY, P0620STY, O0815STY, N0730STY, M0930STY
553323081082403(01) 00885914010549Q1115STY
564001081398486(01) 00885914044513Q0301STY
564003(01) 00885914044537S0922STY, S1101STY, Q0930STY, Q1115STY, P1015STY, M0730STY, M0930STY, M1230STY
564005(01) 00885914044551P0325STY
564006(01) 00885914044568S0922STY, S1101STY, S1214STY, R0310STY, R0601STY, R0801STY, R1101STY, R1201STY, Q0930STY, Q1115STY, P1015STY, O0120STY, N0330STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY
564007(01) 00885914044575S0823STY, S0922STY, S1101STY, R0310STY, R0801STY, R1101STY, R1201STY, Q1115STY, P0325STY, P0620STY, N0730STY, M0130STY, M0730STY, M0930STY, M1230STY
564008(01) 00885914044582S0823STY, S0922STY, S1101STY, S1214STY, R0310STY, R0601STY, R0801STY, R1101STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, N0330STY, N0730STY, M0730STY, M0930STY
564009(01) 00885914044599S0922STY, S1101STY, R0801STY, R1101STY, Q0301STY, Q1115STY, P0325STY, P0620STY, P1015STY, O0815STY, N0330STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY
564010(01) 00885914044605S0823STY, S0922STY, S1101STY, R0601STY, R1101STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, M0730STY
564011(01) 00885914044612S0823STY, S0922STY, S1101STY, R0310STY, R0601STY, R0801STY, R1101STY, R1201STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, O0815STY, N0330STY, N0730STY, M0730STY, M0930STY, M1230STY
564012(01) 00885914044629S0922STY, S1101STY, R0601STY, R1101STY, Q0301STY, Q1115STY, P0325STY, P0620STY, P1015STY, O1020STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY
564013(01) 00885914044636S0823STY, S0922STY, S1101STY, R0801STY, R1101STY, Q0301STY, Q0930STY, P0325STY, P0620STY, O0815STY, N0330STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY
564014(01) 00885914044643S0823STY, S0922STY, S1101STY, S1214STY, R0601STY, R1101STY, Q0301STY, N0730STY, M0130STY, M0730STY, M0930STY
564015(01) 00885914044650S0823STY, S0922STY, S1101STY, R1101STY, Q0301STY, Q1115STY, P0620STY, O0815STY, O1020STY, N0730STY, M0130STY, M0730STY, M0930STY, M1230STY
564017(01) 00885914044674S0922STY, R0310STY, Q0301STY, Q1115STY, O0815STY, O1020STY, N0330STY
564019081398676(01) 00885914044698R0310STY
564044081399153(01) 00885914044964Q0301STY
A70107000081287457(01) 00885914035443R1101STY
A70107001081287465(01) 00885914035450R1201STY, Q0301STY
A70107002081287473(01) 00885914035467S0922STY, S1101STY, R0601STY, R0801STY, Q0301STY, P1015STY, O0120STY, N0730STY, M0130STY
A70107003081287481(01) 00885914035474R0601STY, Q0301STY, Q1115STY, P0620STY, P1015STY, O0120STY, O0815STY, N0330STY, M0130STY, M0430STY, M0730STY, M0930STY
A70107004081287499(01) 00885914035481R0310STY, R1201STY
A70107005081287507(01) 00885914035498S0922STY, S1214STY, R0601STY, R0801STY, Q0301STY, Q1115STY, P0620STY, P1015STY, N0730STY, M0130STY, M0730STY, M0930STY
A70107006081287515(01) 00885914035504S0823STY, S0922STY, S1214STY, R0601STY, R1101STY, Q0930STY, Q1115STY, P0325STY, P1015STY, O0815STY, N0330STY, N0730STY, M0130STY, M0730STY, M0930STY
A70107007081287523(01) 00885914035511S0922STY, S1101STY, S1214STY, R1101STY, R1201STY, Q0301STY, Q1115STY, P0325STY, P1015STY, O0120STY, N0730STY, M1230STY, L0120STY
A70107008081287531(01) 00885914035528S0823STY, S1101STY, R0310STY, R0601STY, R1101STY, R1201STY, Q1115STY, P0325STY, P1015STY, N0730STY, M1230STY, L0120STY
A70107009081287549(01) 00885914035535S0823STY, R0310STY, R0601STY, R1101STY, R1201STY, Q0301STY, Q1115STY, P0325STY, O1020STY, N0730STY, L0120STY
A70107010081287556(01) 00885914035542S0823STY, S0922STY, S1101STY, R0310STY, R1101STY, Q0301STY, Q0930STY, P0325STY, P1015STY, O0120STY, O0815STY, N0730STY, M1230STY, L0120STY
A70107011081287564(01) 00885914035559S0823STY, S0922STY, S1101STY, S1214STY, R0601STY, R0801STY, Q0301STY, N0730STY, M0130STY, M0930STY, M1230STY, L0120STY
A70107012081287572(01) 00885914035566S0922STY, S1101STY, R0601STY, R1101STY, Q0930STY, Q1115STY, P1215STY, O1020STY, N0730STY, M0730STY, M0930STY
A70107013081287580(01) 00885914035573S0922STY, R0310STY, R0601STY, R0801STY, Q1115STY, P0620STY, O0120STY, N0330STY, N0730STY, M0130STY, M0730STY, M0930STY, L0120STY
A70107014081287598(01) 00885914035580Q0930STY, Q1115STY
A70107016081287614(01) 00885914035603P0325STY
A70107017081287622(01) 00885914035610Q0301STY

  ASP Global Branded Sterile Tourniquet Cuff Products Affected Item Codes

Item CodePH SKUUDIAffected Lot Numbers
ASP-5640037035296(01) 00840216106703P1015STY, P1215STY, N0330STY, N0530STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY
ASP-564006081398536(01) 00840216106710P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0730STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY
ASP-5640077035297(01) 00840216106727P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY
ASP-564008081398551(01) 00840216106734P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY
ASP-564009081398569(01) 00840216106741P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY
ASP-5640107035298(01) 00840216106758P1015STY, P1215STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY
ASP-564011081398593(01) 00840216106765P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY
ASP-564012081398601(01) 00840216106772P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY
ASP-564013081398619(01) 00840216106789P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY
ASP-564014081398627(01) 00840216106796P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY
ASP-564015081398635(01) 00840216106802P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY

  MPR Branded Sterile Tourniquet Cuff Products Affected Item Codes

Item CodePH SKUUDIAffected Lot Numbers
DB-7018-01Q(10) UDI was not applicable at time of manufactureN0330STY, Q1115STY
DB-7020-02Q(10) UDI was not applicable at time of manufactureQ1115STY
DB-7024-02Q(10) UDI was not applicable at time of manufactureN0330STY
DT-7018-01Q081435007(10) UDI was not applicable at time of manufactureS1101STY, Q0301STY, P1015STY, N0330STY, N0530STY
DT-7024-01Q081435023(10) UDI was not applicable at time of manufactureS1101STY, R1201STY, Q0301STY, Q1115STY, P1015STY, N0330STY
DT-7024-02Q081434836(10) UDI was not applicable at time of manufactureR1201STY, Q0301STY, Q1115STY, O1020STY, N0330STY, N0530STY, M0930STY
DT-7030-01Q081435122(10) UDI was not applicable at time of manufactureS1101STY, P1015STY, N0330STY, N0730STY
DT-7030-02Q081434844(10) UDI was not applicable at time of manufactureS1101STY, R1201STY, Q1115STY, O1020STY, N0330STY, N0530STY, N0730STY
DT-7034-01Q081435130(10) UDI was not applicable at time of manufactureR1201STY, Q1115STY, P1015STY
DT-7034-02Q081434851(01) 00840001403239S0823STY, S1101STY, R1201STY, Q1115STY, O1020STY, N0330STY, N0530STY, M0930STY
DT-7044-01Q081435148(10) UDI was not applicable at time of manufactureR1201STY, P1015STY
DT-7044-02Q081434869(01) 00840001403253S0823STY, R1201STY, N0330STY, N0530STY, M0730STY, M0930STY
DT-7108-02Q081434786(10) UDI was not applicable at time of manufactureS1101STY, R1201STY
DT-7112-01Q081434984(10) UDI was not applicable at time of manufactureO1020STY, N0530STY
DT-7112-02Q081434794(10) UDI was not applicable at time of manufactureQ0301STY
DT-7115-01Q081434992(10) UDI was not applicable at time of manufactureS1101STY
DT-7115-02Q081434810(10) UDI was not applicable at time of manufactureS1101STY, P1015STY, N0330STY
DT-7218-02Q081434828(01) 00840001403314S0922STY, S1101STY, R1201STY, Q1115STY, P1015STY, N0530STY