MHRA: DSI/2026/009 NGPod Device Recall Mandates UK-Wide Disposal

• The MHRA has issued a DSI/2026/009 directive for the immediate quarantine and disposal of all NGPod pH testing devices in the UK.
• The NGPod pH testing device withdrawal is primarily due to the manufacturer ceasing trading in the UK as of July 20, 2026, making continued support impossible.
• A prior Field Safety Corrective Action (FSCA) was initiated after two adverse incidents in January 2026, where the NGPod device gave misleading 'green' results despite nasogastric tube misplacement in the lung, one of which was fatal.
• The manufacturer had previously updated the device's Instructions For Use (IFU) to include contraindications and clarify that the NGPod system alone does not confirm tube placement.
• Healthcare providers must adhere strictly to the quarantine and dispose NGPod medical device directive to mitigate patient safety risks and potential legal liability.

Compliance officers and legal counsel for healthcare providers must ensure immediate adherence to the MHRA's directive to quarantine and dispose of all NGPod devices to mitigate patient safety risks and potential legal liability, especially given the device's history of inaccurate readings and association with a fatal incident.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a critical directive, DSI/2026/009, mandating the immediate quarantine and disposal of all NGPod devices across the UK. This comprehensive MHRA DSI/2026/009 NGPod device recall affects both the handheld device and its associated sensor, which are designed to test pH levels to assist in the correct placement of nasogastric tubes. Healthcare providers are instructed to cease all use of these devices without delay.

The urgent NGPod pH testing device withdrawal stems primarily from the manufacturer's cessation of trading in the UK as of July 20, 2026. This means the manufacturer can no longer provide essential support for the continued use of the medical device, prompting their decision to recall the product from the market. Without appropriate manufacturer oversight, the MHRA has identified a significant risk of patient harm should the device remain in use.

Consequently, all healthcare facilities and individual practitioners are required to quarantine NGPod devices UK-wide, securing any remaining stock. Following this, the directive instructs users to dispose NGPod medical device units in accordance with established protocols. This measure is crucial to prevent any further use of the unsupported equipment and to mitigate potential risks to patient safety.

While the manufacturer's cessation of trading is the immediate catalyst for the recall, the NGPod system has a documented history of safety concerns that previously led to a Field Safety Corrective Action (FSCA) earlier this year. This FSCA was initiated following the assessment of two adverse incident reports received by the MHRA in January 2026, highlighting critical flaws in the device's performance.

In both reported incidents, the NGPod device provided a 'green' result, which typically indicates an acidic pH (below 5.5), suggesting that the nasogastric tube had been correctly placed. However, subsequent investigations revealed that in these cases, the nasogastric tube misplacement NGPod had occurred, with the tube erroneously located in the patient's lung. Tragically, one of these adverse incidents resulted in a fatal outcome.

The MHRA acknowledged that multiple factors likely contributed to the patient's death. However, the agency could not definitively rule out a contributing role of the NGPod result within the clinical decision pathway. These incidents underscored the potential for the device to provide misleading information, leading to severe patient harm.

The Medicines and Healthcare products Regulatory Agency NGPod engagement predates the current recall. Following the adverse incident reports, the MHRA had requested NGPod Global to initiate the aforementioned Field Safety Corrective Action. In discussions with the regulatory body, the manufacturer had previously made updates to the device's Instructions For Use (IFU).

These updates aimed to address identified risks by incorporating specific contraindications. These included prohibiting use in patients experiencing significant aspiration of gastric contents, individuals with conditions where the respiratory tract might contain acidic secretions, and situations where clinical assessment indicated that radiographic confirmation of tube placement was essential. Furthermore, the revised IFU clarified that the NGPod system alone is insufficient to determine anatomical tube location and does not independently confirm nasogastric tube placement, emphasizing its role as an aid rather than a definitive diagnostic tool.

The MHRA's directive carries significant implications for healthcare providers, necessitating immediate and thorough compliance. Compliance officers and legal counsel for healthcare providers must ensure immediate adherence to the MHRA's directive to quarantine and dispose of all NGPod devices to mitigate patient safety risks and potential legal liability, especially given the device's history of inaccurate readings and association with a fatal incident. The continued use of an unsupported and potentially faulty medical device could expose institutions to considerable legal and reputational risks.

Beyond the immediate recall, healthcare providers are strongly advised to review their internal protocols for nasogastric tube placement and verification, ensuring that alternative, validated methods are in place and consistently followed. Furthermore, a comprehensive review of past patient cases where the NGPod device was utilized should be considered, particularly for patients who experienced adverse events following tube placement. Healthcare professionals are also reminded of their ongoing responsibility to report any incidents involving medical devices, with specific guidance provided for reporting in Scotland via the Incident Reporting & Investigation Centre (IRIC) and local systems.

Compliance officers and legal counsel for healthcare providers must ensure immediate adherence to the MHRA's directive to quarantine and dispose of all NGPod devices to mitigate patient safety risks and potential legal liability, especially given the device's history of inaccurate readings and association with a fatal incident. They should also review internal protocols and past patient cases where this device was used.

Source: Original reporting via GOV.UK