electronic Recalls

325 recalls tagged with “electronic”.

Health & Personal Care
HIGH
FDA DEVICE

BD Recalls 38 Veritor Connect Software Units Over Credential Access Risk (2025)

BD recalled 38 Veritor Connect Software units distributed to healthcare providers worldwide. Unauthorized access to product service credentials could affect confidentiality, integrity or availability of the product and data. Stop using the software and follow the recall instructions provided by the manufacturer.

BD
Product service
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Health & Personal Care
HIGH
FDA DEVICE

BD EpiCenter Recall: 2,050 Units Worldwide Over Unauthorized Access Risk

BD recalled 2,050 units of the EpiCenter Microbiology Data Management System due to unauthorized access to product service credentials. The defect could allow access to confidential data. Stop using affected devices and follow manufacturer guidance for updates or replacement.

Becton Dickinson &
Product service
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Health & Personal Care
HIGH
FDA DEVICE

BD Recalls 62 BD MAX System IVD Units Worldwide Over Credential Breach (2025)

BD MAX System recall affects 62 units distributed worldwide in 2025 after unauthorized access to service credentials. An unauthorized actor accessed credentials used by BD technical support teams. Healthcare providers should stop using the devices and follow the manufacturer’s recall instructions.

BD
Product service
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls 160 DxC 500i Modules and DxI 9000 Analyzers in 2025 Recall

Beckman Coulter recalls 160 DxC 500i Clinical Analyzer Modules and the DxI 9000 Access Immunoassay Analyzer worldwide after a software anomaly could misapply manual dilution factors. The defect affects samples already in progress using the same Sample ID. Stop using the devices immediately and follow the recall instructions. Beckman Coulter will provide instructions via the recall process.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls 571 DxI 9000 Immunoassay Analyzers and DxC 500i (2025)

Beckman Coulter recalled 571 DxI 9000 Access Immunoassay Analyzers and DxC 500i Clinical Analyzers distributed worldwide. A software anomaly may prevent correct application of manual dilution factors for tests already in progress on the same Sample ID. Labs should stop using the devices immediately and follow recall instructions.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DEVICE

HeartSine Pad-Pak Defibrillator Pads Recalled for 1,291,165 Units in 2025

HeartSine Technologies recalled 1,291,165 Pad-Pak defibrillator pads sold nationwide in the United States and worldwide. A defect may allow damage pins to disrupt the mechanical fit and electrical contact. Stop using the pads immediately and follow the manufacturer's recall instructions.

HeartSine Technologies
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Fisher & Paykel Recall 51,144 Airvo 2 and myAirvo 2 Humidifiers Over Power-Disconnect Audible Alert

Fisher & Paykel Healthcare recalled 51,144 Airvo 2 and myAirvo 2 humidifiers in the United States. The devices may emit an audible alert for less than 120 seconds after power is disconnected. This could delay user awareness to reconnect power and lead to oxygen desaturation. Patients and healthcare providers should stop using the device and await manufacturer instructions.

Fisher & Paykel Healthcare
When unintentionally
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems LOGIQ P9 R4.5 Ultrasound System Recalled for Inaccurate Liver Readings (37 Units)

GE Medical Systems recalled 37 LOGIQ P9 R4.5 ultrasound systems sold nationwide in the United States and globally after regulators flagged UGAP measurements that may misrepresent liver steatosis. The UGAP data may display inaccurate values representing liver steatosis, potentially guiding inappropriate clinical decisions. Clinicians should stop using the affected devices and await recall guidance.

GE Medical Systems
The Ultrasound-Guided
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Health & Personal Care
HIGH
FDA DEVICE

Cardinal Health 200 Salem Sump Anti-Reflux Valve Recalled for Breakage Risk (2025)

Cardinal Health 200, LLC recalls all lots of the Salem Sump Anti-Reflux Valve worldwide after complaints of valve breakage. The recall covers CE-marked valves with multiple identifiers. Hospitals and clinicians should stop using the device immediately and follow manufacturer instructions. This notice alerts providers to check for the affected code and act now.

Cardinal Health
Firm has
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Health & Personal Care
HIGH
FDA DEVICE

Cardinal Health 200 Salem Sump Gastroduodenal Tubes Recalled Worldwide for ARV Breakage

Cardinal Health 200, LLC recalled Salem Sump gastroduodenal tubes worldwide after reports of anti-reflux valve breakage. The ARV can fail under excessive force during use. Healthcare providers and patients should stop using the device immediately and follow the manufacturer instructions for recall communication.

Cardinal Health 200
Firm has
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Oral Probe Recalled for 5,209 Units Misconfigured as Rectal Probes (2025)

Baxter Healthcare recalled 5,209 oral/axillary probes used with Welch Allyn SureTemp Plus thermometers nationwide in the United States, Canada and Colombia. The probes were inadvertently programmed with the rectal configuration, which can yield a lower temperature reading. Healthcare providers and patients should stop using the affected probes immediately and follow Baxter’s recall instructions.

Baxter Healthcare
Affected oral/axillary
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Health & Personal Care
HIGH
FDA DEVICE

Enterix InSure ONE FIT Recall Affects 201,426 Tests Over False Negatives (2025)

Enterix recalled 201,426 InSure ONE Fecal Immunochemical Test kits after a sensitivity failure linked to Test Card Lot TT241102. The issue may cause false negative results. Healthcare providers and patients should stop using the affected kits and follow the manufacturer’s recall instructions.

Enterix
InSure ONE
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Health & Personal Care
HIGH
FDA DRUG

Accord Healthcare Recalls 54,432 Levothyroxine 88 mcg Tablets for Subpotent Potency (2025)

Accord Healthcare recalled 54,432 bottles of Levothyroxine Sodium Tablets, USP, 88 mcg, distributed nationwide in the United States. The recall is due to subpotent assay content observed during long-term stability testing. Patients should stop using the product immediately and contact Accord Healthcare or their healthcare provider for guidance.

Levothyroxine Sodium
Subpotent: During
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Health & Personal Care
HIGH
FDA DRUG

IntegraDose Oxytocin IV Solution Recall 2025 for Subpotent Drug, 853 Bags Nationwide

IntegraDose Compounding Services recalled 853 IV bags of Oxytocin 30 Units/500 mL in 0.9% sodium chloride. The recall is nationwide in the United States. Testing found no oxytocin in the IV bags. Stop using the product and contact IntegraDose or a healthcare provider for guidance.

IntegraDose Compounding Services
Subpotent Drug:
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Health & Personal Care
HIGH
FDA DEVICE

Alcon CONSTELLATION Ultravit 10K & HyperVit 20K Recall for 28,323 Units (2025)

Alcon recalls 28,323 CONSTELLATION Ultravit 10K and CONSTELLATION HyperVit 20K devices used in hospitals worldwide. The recall lists an unspecified hazard. Hospitals should stop using the devices immediately and follow the manufacturer’s instructions. Access the FDA recall notice for details.

Alcon
XXX
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Health & Personal Care
HIGH
FDA DEVICE

Noah Medical Galaxy System GAL-001 Recall of 47 Units for Password-Protected Manual Access (2025)

Noah Medical recalled 47 Galaxy System bronchoscopic visualization devices distributed to 20 US states and internationally to Hong Kong and Australia. The recall centers on password-protected Instructions for Use. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.

Noah Medical
Due to
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