nhtsa regulated Recalls

370 recalls tagged with “nhtsa regulated”.

Health & Personal Care
HIGH
FDA DEVICE

GE Healthcare Recalls 82 Millenium Myosight Dual-Head Gamma Cameras for Cardiac Imaging (2025)

GE HealthCare recalled 82 Millenium Myosight dual-head gamma cameras distributed worldwide. The devices could have been moved without adequate detector mounting support. This could cause a detector fall and life-threatening injury. Hospitals and healthcare providers should stop using the cameras immediately and follow manufacturer recall instructions.

GE Healthcare
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems Israel Recalls Elscint SPX4 Gamma Camera for Cardiac Imaging

GE Medical Systems Israel is recalling 45 units of the Elscint SPX4 dual-head gamma camera worldwide. The recall cites a risk from transporting or relocating systems past End of Guaranteed Service without adequate detector support. Hospitals and clinics should stop using the device immediately and follow manufacturer instructions.

GE Medical Systems Israel
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems Israel Recalls 11 Elscint Cardial Gamma Cameras in 2025

GE Medical Systems Israel recalls 11 Elscint Cardial dual-head gamma cameras used for cardiac imaging worldwide. The recall concerns detector mounting that could fail if the unit is moved without proper support. Hospitals should stop using these devices immediately and follow GE’s recall instructions.

GE Medical Systems Israel
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-P150 Bronchoscope Recall Expanded Over IFU Clarifications (2025)

Olympus Corporation of the Americas recalls its BF-P150 bronchoscope after updates to the instruction for use. The recall covers 1,019 units outside the U.S. Distribution was nationwide in the U.S. The agency classifies this as a high-hazard issue.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-H190 Bronchovideoscope Recall Expanded for IFU Updates in 2025

Olympus Corporation of the Americas recalls 5,221 units sold in the U.S. and 4,321 units overseas. The recall covers the EVIS EXERA III BRONCHOVIDEOSCOPE BF-H190. It flags updated instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

CareFusion 303 BD Alaris Infusion Sets Recalled for Flow, Bolus Accuracy Issues (2025)

CareFusion 303 BD Alaris infusion pump modules and compatible infusion sets are recalled nationwide in the U.S. and multiple international markets. The recall covers reference numbers including C24101E and 10015414 and related SmartSite components. The defect may cause flow rate and bolus accuracy deviations, and incorrect occlusion timing. Stop using the device and follow recall instructions from

CareFusion
Infusion pump
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Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA II BF-P180 Bronchovideoscope Recalled; 3,250 Units Affected Worldwide (2025)

Olympus Corporation of the Americas recalls 3,250 EVIS EXERA II BF-P180 Bronchovideoscopes sold in the United States and internationally. The recall updates the instructions for use to clarify safe and effective use with laser, argon plasma coagulation, and high-frequency therapy equipment. Healthcare providers should stop using the device immediately and contact Olympus for instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

NOXBOX NOxBOXi Nitric Oxide Delivery System Recalled for 1,667 Units in 2025

NOXBOX LTD recalled 1,667 NOxBOXi Nitric Oxide Delivery System units distributed in Tennessee after reports of flow and dose fluctuations. The device can show fluctuations when the total flow through its sensor drops below 0.5 LPM. Dose fluctuations have been observed with LifePulse HFJV or conventional ventilators under certain settings. Stop using the device immediately and follow the recall. NO

NOXBOX
Fluctuations may
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Health & Personal Care
HIGH
FDA DEVICE

Draeger Atlan A350XL Anesthesia Workstation Recalled for Ventilator Failure Risk (223 Units) in 25+N

Draeger recalls 223 Atlan A350XL anesthesia workstations distributed in 25 states and many countries after reports of piston ventilator failure and mechanical ventilation failures. The recall affects units imported from Draegerwerk AG and Co. KGaA. Stop using the device immediately. Contact Draeger for instructions and patient safety guidance.

Draeger
The device
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound X3-1 Transducer Recalled for Labeling Clarification in 2026 (17 Units)

Philips Ultrasound recalled 17 X3-1 ultrasound transducers nationwide in the United States. The recall is to provide clarification and labeling to define the useful life of transducers in the field. Healthcare providers and patients should stop using the affected devices immediately and await further manufacturer instructions.

Philips Ultrasound
To provide
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Health & Personal Care
LOW
FDA DEVICE

Philips 3D6-2 Ultrasound Transducer Recalled for Labeling Clarification (17 Units, 2025)

Philips recalled 17 units of the 3D6-2 Ultrasound Transducer distributed nationwide to healthcare facilities in the United States. The recall seeks to clarify labeling defining the transducer’s useful life. Clinicians and facilities should stop using the device immediately and follow Philips recall instructions.

Philips Ultrasound
To provide
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound S5-2 Transducer Recall 2025 - 1 Unit Nationwide

Philips Ultrasound recalled 1 unit of the S5-2 Ultrasound Transducer sold nationwide through healthcare distributors. The recall clarifies labeling to define the useful life of the transducer in the field. Healthcare providers should stop using the device and contact Philips Ultrasound for instructions.

Philips Ultrasound
To provide
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems AW Server 2.0, AW Server 3.0, 3.1, 3.2 Recalled For Security Breach Risk (2025)

GE Medical Systems recalled 7,302 AW Server models worldwide, including 1,381 units in the U.S., after identifying a security vulnerability that could expose patient data. The defect could allow a malicious actor to compromise confidentiality, integrity and availability of information. Healthcare providers should stop using the devices immediately and follow manufacturer instructions for recall.

GE Medical Systems
Firm has
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Health & Personal Care
HIGH
FDA DRUG

Apotex Ketorolac Tromethamine Ophthalmic Solution Recall 2025: 493,468 Bottles Nationwide

Apotex Corp. is recalling 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Rx Only, sterile, distributed nationwide in the United States. The recall cites lack of assurance of sterility due to improper bottle sealing. Consumers and healthcare providers should stop using the product immediately and contact Apotex Corp. or their healthcare provider for guidance.

Apotex
Lack of
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Tag Statistics

Total Recalls
370

Related Tags

fall hazardelectronicimmediate actionstop use immediatelyreplacement availablereturn for refundworkplacefda regulatedcpsc regulatedelectrical hazardoutdoorkitchen
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