Siemens StreamLab Refrigerated Storage Module Recall for Missing Warning Label
Siemens is recalling StreamLab Refrigerated Storage Modules because they may lack a warning label regarding potential interference with pacemaker functionality.
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: The recall involves a risk of harm to pacemaker functionality, which is a high-risk hazard, but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 186 StreamLab Refrigerated Storage Module 15000 units. The recall was initiated because the modules may have been shipped without a warning label indicating a potential risk of interference to pacemaker functionality.
The affected products were distributed to numerous US states, including Alabama, Arizona, California, Florida, New York, and Texas, as well as to various foreign countries such as Canada, Germany, India, and the United Kingdom. The specific Siemens Material Number for the affected units is 10482428, and the UDI is 00630414949765.
Hospitals and healthcare facilities should check their inventory for these specific modules. If a unit is found, it should be removed from service and the manufacturer contacted for further instructions regarding the missing warning label.
The recalled product
- Product
- STREAMLAB - REFRIGERATED STORAGE MODULE 15000
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 186
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 (2)
- Siemens Material Numbers: 10482428
- UDI: 00630414949765
Distribution
Part of a larger recall action
This product is one of 9 recalled by Siemens Healthcare Diagnostics, Inc. 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 9 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · electromagnetic interference
See all →- HighSix foot display cables recalled over inadequate shielding and interference
FDA (Devices) · 2025-10-22
- HighTwelve foot display cables recalled over inadequate shielding and interference
FDA (Devices) · 2025-10-22
- HighMonitor display cables recalled over inadequate shielding and electromagnetic interference
FDA (Devices) · 2025-10-22
- HighOperating tables recalled because interference can leave them unresponsive to controls
FDA (Devices) · 2025-09-03
- HighOlympus Quest Spectrum 3 Fluorescent Imaging System Recalled for EMC Defect
FDA (Devices) · 2024-11-06
Similar recalls
- ModerateSiemens FlexLab Automation Modules Recalled for Potential Safety Concerns
FDA (Devices) · 2016-11-23
- HighSiemens StreamLAB Analytical Workcell Recalled for Trip and Fall Hazard
FDA (Devices) · 2014-07-02
- HighSiemens Hettich Centrifuge Modules Recalled for Premature Bucket Failures
FDA (Devices) · 2016-07-06
- HighSiemens Reagent Management System Recalled for Electrical Safety Hazard
FDA (Devices) · 2015-12-30
- HighSiemens Reagent Management System Recalled for Electrical Hazard
FDA (Devices) · 2015-12-30
- ModerateSiemens EasyLink Data Management System Recalled for Software Limitations
FDA (Devices) · 2015-07-08