MHRA Issues DSI/2026/009 for NGPod pH Testing Device: Manufacturer Ceases Operations, Product Withdrawn and Must Be Destroyed

MHRA Issues DSI/2026/009 for NGPod pH Testing Device: Manufacturer Ceases Operations, Product Withdrawn and Must Be Destroyed

Published on 13 October 2026 13:32 | Recalls and Safety Alerts

On 24 August 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued Device Safety Information DSI/2026/009 concerning the NGPod handheld device and NGPod sensor, which are intended to aid nasogastric (NG) tube placement. The document states that the product will be withdrawn from the UK market; the manufacturer has ceased operations in the UK and is unable to continue supporting product use. Users should quarantine all remaining stock and destroy all NGPod devices.

Two Issues to Separate

The document actually addresses two matters. One is the corporate status: MHRA states that NGPod Global ceased UK operations on 20 July 2026 and is therefore unable to support continued use of the medical device. MHRA specifically notes that the cessation of operations itself is not directly related to the current safety concerns. The other matter is the safety event. In January 2026, MHRA received two UK adverse event reports and subsequently required the company to initiate a Field Safety Corrective Action (FSCA). Both reports had the same scenario: the device gave a green result indicating pH < 5.5, clinicians therefore considered the NG tube correctly placed, but the tube was later found to be in the lung.

One of these cases resulted in death. Regarding causation for the fatal case, MHRA's wording leaves room: according to its explanation, multiple factors were considered related to the death, but it cannot be excluded that the NGPod test result played a role in the clinical decision pathway. This phrasing places the device result back into the entire clinical decision chain for assessment, rather than attributing causation unilaterally.

Previous Corrective Actions by the Manufacturer

After communication with MHRA, the manufacturer updated the Instructions for Use (IFU), adding three new contraindications: patients with obvious aspiration of gastric contents, airways that may contain acidic secretions, and situations where clinical assessment indicates a need for imaging confirmation. The IFU also added that the NGPod system itself cannot determine the anatomical location of the tube, nor can it independently confirm whether NG tube placement is correct. These changes occurred before the cessation of operations and market withdrawal, following a path of first revising the IFU, then losing support due to the disappearance of the legal entity.

Official Requirements for Users and Distribution Channels

For healthcare institutions and professionals, MHRA's requirements can be broken down into four steps. First, immediately stop using the NGPod handheld device and sensor. Second, identify, quarantine, and destroy all NGPod devices, because the manufacturer can no longer accept returns. Third, return confirmation of the field safety notice to the manufacturer. Fourth, switch to other pH testing methods to aid NG tube placement, and follow local and national guidance. MHRA added a prerequisite: the alternative pH testing method should bear a CE mark and have a manufacturer's intended purpose of testing human gastric fluid. Users should also inventory local stocks of alternative pH testing devices to ensure continuity of care.

For distribution channels, MHRA requires identifying all NGPod devices in stock and under control, immediately stopping supply, quarantining and destroying them, and notifying customers who may have received affected devices of the actions required. Adverse event reporting channels differ by region: England and Wales use the Yellow Card system; Scotland uses IRIC and local incident recording systems; Northern Ireland also uses the Yellow Card and follows the agency's medical device policy. The document states that there is no patient-facing notification for this action because the relevant actions are carried out by professionals.

Why This Withdrawal Case Is Worth Reading

On the surface, this is merely the withdrawal of a small-volume product. Upon closer examination, it presents three risk patterns simultaneously. First, the capability boundary of the testing method. A green result was treated as evidence of correct placement, but pH value cannot determine anatomical location. Second, the time limit of IFU remediation. An IFU update can narrow the scope of use, but once the legal entity ceases operations, this layer of remediation loses its vehicle for continued enforcement. Third, replacement preparation. Product withdrawal does not equal simply switching brands; users must confirm that the alternative method bears a CE mark, has an intended purpose matching human gastric fluid, and must inventory stock in advance. For companies producing similar placement aids or point-of-care testing products, these three points are not isolated cases.

Sources and Applicability Notes

Source: UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Safety Information DSI/2026/009, 'NGPod pH testing device: quarantine and dispose of all devices', published 24 August 2026.

• https://www.gov.uk/drug-device-alerts/ngpod-ph-testing-device-quarantine-and-dispose-of-all-devices-dsi-slash-2026-slash-009
• MHRA Device Safety Information PDF original, downloadable version of the same document: https://assets.publishing.service.gov.uk/media/6a8c40cca8f84a582b842838/NGPod_pH_testing_device_quarantine_and_dispose_of_all_devices__DSI2026009_.pdf
• MHRA Alerts, recalls and safety information: medicines and medical devices listing page, used to verify the issuing body, publication type, and publication date of this DSI: https://www.gov.uk/drug-device-alerts

Verification scope and access date: This review verified the full text of the above DSI page, including summary, advice for healthcare institutions and distribution channels, risk explanation, reporting channels, and additional information, and cross-checked against the MHRA Device Safety Information PDF and MHRA alerts listing page; access date was 13 October 2026. The affected scope is subject to the official original text; MHRA lists affected lot numbers and serial numbers as 'All'. This article does not reproduce the model list item by item.

Applicability notes: This article is an interpretation of publicly available UK MHRA regulatory information and does not constitute a conclusion or commitment regarding any specific product, company, or registration application. The adverse event course and causation judgment for the fatal case are based on the wording of the MHRA original text and do not constitute a determination of the primary cause of the event. Withdrawal and disposal requirements are UK market arrangements; different regulatory jurisdictions may have different determinations and requirements for similar products. For specific products, the latest notices from local regulatory authorities and manufacturers should prevail, and information may change with subsequent official updates.

Information sources:

• Medicines and Healthcare products Regulatory Agency (MHRA) — Device Safety Information (DSI/2026/009) 2026-08-24
• Medicines and Healthcare products Regulatory Agency (MHRA) — DSI/2026/009 original PDF
• Medicines and Healthcare products Regulatory Agency (MHRA) — Alerts, recalls and safety information: medicines and medical devices

AIMEILI Regulatory Interpretation and Business Impact

From AIMEILI's perspective, this MHRA DSI highlights several critical regulatory and business considerations for medical device manufacturers, distributors, CROs, and regulatory affairs teams.

Regulatory Interpretation

• Manufacturer cessation triggers market withdrawal: When a manufacturer ceases operations, it can no longer fulfill post-market surveillance, vigilance, and corrective action obligations. Regulatory authorities may require withdrawal and destruction of devices, leaving users to find alternatives. Companies should have contingency plans for business continuity and regulatory obligations.
• FSCA and IFU limitations: The case shows that updating an IFU can mitigate risks but is not a substitute for robust design and clinical evidence. If the legal entity disappears, the IFU update becomes unenforceable. Manufacturers should ensure that risk controls are not solely dependent on labeling.
• Clinical decision support and device limitations: The device provided a pH result that was misinterpreted as anatomical placement confirmation. Manufacturers of point-of-care and diagnostic aids must clearly communicate limitations and ensure that intended use and contraindications are unambiguous.
• Alternative device requirements: MHRA specified that replacement pH testing methods must bear a CE mark and be intended for testing human gastric fluid. This underscores the importance of intended purpose and regulatory status when selecting alternatives.
• Regional reporting channels: Adverse event reporting requirements vary across the UK. Companies should ensure their vigilance procedures cover Yellow Card, IRIC, and local incident reporting systems as applicable.

Business Impact

• Supply chain and inventory management: Distributors must immediately identify, quarantine, and destroy affected devices, and notify customers. This can cause operational disruption and require clear communication plans.
• Continuity of care: Healthcare providers must inventory alternative pH testing devices to avoid gaps in NG tube placement confirmation. This may drive demand for compliant alternatives.
• Opportunities for compliant manufacturers: Manufacturers of CE-marked pH testing devices intended for human gastric fluid may see increased demand in the UK. However, they must ensure their intended purpose, labeling, and clinical evidence align with MHRA expectations.
• Risk management and due diligence: Companies should assess their own dependence on single manufacturers or suppliers and evaluate the regulatory status and business stability of partners.
• Regulatory intelligence: This case demonstrates the need to monitor MHRA DSIs and other regulatory alerts to respond quickly to safety actions and market changes.

AIMEILI advises manufacturers and distributors to review their post-market surveillance systems, ensure clear intended use and contraindications, and prepare contingency plans for supply chain disruptions. For regulatory affairs teams, this case reinforces the importance of robust clinical evaluation, risk management, and labeling that accurately reflects device limitations.