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 Code | PH SKU | UDI | Affected Lot Numbers |
| 553322 | 081082395 | (01) 00885914010532 | S0922STY, R0310STY, R0801STY, Q0930STY, P0620STY, O0815STY, N0730STY, M0930STY |
| 553323 | 081082403 | (01) 00885914010549 | Q1115STY |
| 564001 | 081398486 | (01) 00885914044513 | Q0301STY |
| 564003 | (01) 00885914044537 | S0922STY, S1101STY, Q0930STY, Q1115STY, P1015STY, M0730STY, M0930STY, M1230STY | |
| 564005 | (01) 00885914044551 | P0325STY | |
| 564006 | (01) 00885914044568 | S0922STY, S1101STY, S1214STY, R0310STY, R0601STY, R0801STY, R1101STY, R1201STY, Q0930STY, Q1115STY, P1015STY, O0120STY, N0330STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY | |
| 564007 | (01) 00885914044575 | S0823STY, S0922STY, S1101STY, R0310STY, R0801STY, R1101STY, R1201STY, Q1115STY, P0325STY, P0620STY, N0730STY, M0130STY, M0730STY, M0930STY, M1230STY | |
| 564008 | (01) 00885914044582 | S0823STY, S0922STY, S1101STY, S1214STY, R0310STY, R0601STY, R0801STY, R1101STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, N0330STY, N0730STY, M0730STY, M0930STY | |
| 564009 | (01) 00885914044599 | S0922STY, S1101STY, R0801STY, R1101STY, Q0301STY, Q1115STY, P0325STY, P0620STY, P1015STY, O0815STY, N0330STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY | |
| 564010 | (01) 00885914044605 | S0823STY, S0922STY, S1101STY, R0601STY, R1101STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, M0730STY | |
| 564011 | (01) 00885914044612 | S0823STY, S0922STY, S1101STY, R0310STY, R0601STY, R0801STY, R1101STY, R1201STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, O0815STY, N0330STY, N0730STY, M0730STY, M0930STY, M1230STY | |
| 564012 | (01) 00885914044629 | S0922STY, S1101STY, R0601STY, R1101STY, Q0301STY, Q1115STY, P0325STY, P0620STY, P1015STY, O1020STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY | |
| 564013 | (01) 00885914044636 | S0823STY, S0922STY, S1101STY, R0801STY, R1101STY, Q0301STY, Q0930STY, P0325STY, P0620STY, O0815STY, N0330STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY | |
| 564014 | (01) 00885914044643 | S0823STY, S0922STY, S1101STY, S1214STY, R0601STY, R1101STY, Q0301STY, N0730STY, M0130STY, M0730STY, M0930STY | |
| 564015 | (01) 00885914044650 | S0823STY, S0922STY, S1101STY, R1101STY, Q0301STY, Q1115STY, P0620STY, O0815STY, O1020STY, N0730STY, M0130STY, M0730STY, M0930STY, M1230STY | |
| 564017 | (01) 00885914044674 | S0922STY, R0310STY, Q0301STY, Q1115STY, O0815STY, O1020STY, N0330STY | |
| 564019 | 081398676 | (01) 00885914044698 | R0310STY |
| 564044 | 081399153 | (01) 00885914044964 | Q0301STY |
| A70107000 | 081287457 | (01) 00885914035443 | R1101STY |
| A70107001 | 081287465 | (01) 00885914035450 | R1201STY, Q0301STY |
| A70107002 | 081287473 | (01) 00885914035467 | S0922STY, S1101STY, R0601STY, R0801STY, Q0301STY, P1015STY, O0120STY, N0730STY, M0130STY |
| A70107003 | 081287481 | (01) 00885914035474 | R0601STY, Q0301STY, Q1115STY, P0620STY, P1015STY, O0120STY, O0815STY, N0330STY, M0130STY, M0430STY, M0730STY, M0930STY |
| A70107004 | 081287499 | (01) 00885914035481 | R0310STY, R1201STY |
| A70107005 | 081287507 | (01) 00885914035498 | S0922STY, S1214STY, R0601STY, R0801STY, Q0301STY, Q1115STY, P0620STY, P1015STY, N0730STY, M0130STY, M0730STY, M0930STY |
| A70107006 | 081287515 | (01) 00885914035504 | S0823STY, S0922STY, S1214STY, R0601STY, R1101STY, Q0930STY, Q1115STY, P0325STY, P1015STY, O0815STY, N0330STY, N0730STY, M0130STY, M0730STY, M0930STY |
| A70107007 | 081287523 | (01) 00885914035511 | S0922STY, S1101STY, S1214STY, R1101STY, R1201STY, Q0301STY, Q1115STY, P0325STY, P1015STY, O0120STY, N0730STY, M1230STY, L0120STY |
| A70107008 | 081287531 | (01) 00885914035528 | S0823STY, S1101STY, R0310STY, R0601STY, R1101STY, R1201STY, Q1115STY, P0325STY, P1015STY, N0730STY, M1230STY, L0120STY |
| A70107009 | 081287549 | (01) 00885914035535 | S0823STY, R0310STY, R0601STY, R1101STY, R1201STY, Q0301STY, Q1115STY, P0325STY, O1020STY, N0730STY, L0120STY |
| A70107010 | 081287556 | (01) 00885914035542 | S0823STY, S0922STY, S1101STY, R0310STY, R1101STY, Q0301STY, Q0930STY, P0325STY, P1015STY, O0120STY, O0815STY, N0730STY, M1230STY, L0120STY |
| A70107011 | 081287564 | (01) 00885914035559 | S0823STY, S0922STY, S1101STY, S1214STY, R0601STY, R0801STY, Q0301STY, N0730STY, M0130STY, M0930STY, M1230STY, L0120STY |
| A70107012 | 081287572 | (01) 00885914035566 | S0922STY, S1101STY, R0601STY, R1101STY, Q0930STY, Q1115STY, P1215STY, O1020STY, N0730STY, M0730STY, M0930STY |
| A70107013 | 081287580 | (01) 00885914035573 | S0922STY, R0310STY, R0601STY, R0801STY, Q1115STY, P0620STY, O0120STY, N0330STY, N0730STY, M0130STY, M0730STY, M0930STY, L0120STY |
| A70107014 | 081287598 | (01) 00885914035580 | Q0930STY, Q1115STY |
| A70107016 | 081287614 | (01) 00885914035603 | P0325STY |
| A70107017 | 081287622 | (01) 00885914035610 | Q0301STY |


ASP Global Branded Sterile Tourniquet Cuff Products Affected Item Codes
| Item Code | PH SKU | UDI | Affected Lot Numbers |
| ASP-564003 | 7035296 | (01) 00840216106703 | P1015STY, P1215STY, N0330STY, N0530STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY |
| ASP-564006 | 081398536 | (01) 00840216106710 | P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0730STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY |
| ASP-564007 | 7035297 | (01) 00840216106727 | P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY |
| ASP-564008 | 081398551 | (01) 00840216106734 | P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY |
| ASP-564009 | 081398569 | (01) 00840216106741 | P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY |
| ASP-564010 | 7035298 | (01) 00840216106758 | P1015STY, P1215STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY |
| ASP-564011 | 081398593 | (01) 00840216106765 | P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY |
| ASP-564012 | 081398601 | (01) 00840216106772 | P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY |
| ASP-564013 | 081398619 | (01) 00840216106789 | P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY |
| ASP-564014 | 081398627 | (01) 00840216106796 | P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY |
| ASP-564015 | 081398635 | (01) 00840216106802 | P1015STY, 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 Code | PH SKU | UDI | Affected Lot Numbers |
| DB-7018-01Q | (10) UDI was not applicable at time of manufacture | N0330STY, Q1115STY | |
| DB-7020-02Q | (10) UDI was not applicable at time of manufacture | Q1115STY | |
| DB-7024-02Q | (10) UDI was not applicable at time of manufacture | N0330STY | |
| DT-7018-01Q | 081435007 | (10) UDI was not applicable at time of manufacture | S1101STY, Q0301STY, P1015STY, N0330STY, N0530STY |
| DT-7024-01Q | 081435023 | (10) UDI was not applicable at time of manufacture | S1101STY, R1201STY, Q0301STY, Q1115STY, P1015STY, N0330STY |
| DT-7024-02Q | 081434836 | (10) UDI was not applicable at time of manufacture | R1201STY, Q0301STY, Q1115STY, O1020STY, N0330STY, N0530STY, M0930STY |
| DT-7030-01Q | 081435122 | (10) UDI was not applicable at time of manufacture | S1101STY, P1015STY, N0330STY, N0730STY |
| DT-7030-02Q | 081434844 | (10) UDI was not applicable at time of manufacture | S1101STY, R1201STY, Q1115STY, O1020STY, N0330STY, N0530STY, N0730STY |
| DT-7034-01Q | 081435130 | (10) UDI was not applicable at time of manufacture | R1201STY, Q1115STY, P1015STY |
| DT-7034-02Q | 081434851 | (01) 00840001403239 | S0823STY, S1101STY, R1201STY, Q1115STY, O1020STY, N0330STY, N0530STY, M0930STY |
| DT-7044-01Q | 081435148 | (10) UDI was not applicable at time of manufacture | R1201STY, P1015STY |
| DT-7044-02Q | 081434869 | (01) 00840001403253 | S0823STY, R1201STY, N0330STY, N0530STY, M0730STY, M0930STY |
| DT-7108-02Q | 081434786 | (10) UDI was not applicable at time of manufacture | S1101STY, R1201STY |
| DT-7112-01Q | 081434984 | (10) UDI was not applicable at time of manufacture | O1020STY, N0530STY |
| DT-7112-02Q | 081434794 | (10) UDI was not applicable at time of manufacture | Q0301STY |
| DT-7115-01Q | 081434992 | (10) UDI was not applicable at time of manufacture | S1101STY |
| DT-7115-02Q | 081434810 | (10) UDI was not applicable at time of manufacture | S1101STY, P1015STY, N0330STY |
| DT-7218-02Q | 081434828 | (01) 00840001403314 | S0922STY, S1101STY, R1201STY, Q1115STY, P1015STY, N0530STY |







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