replacement available Recalls

1,215 recalls tagged with “replacement available”.

Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Recalls SMV DSXi Nuclear Medicine Gamma Camera (205 Units) for Cardiac Imaging

GE HealthCare recalled 205 SMV DSXi dual-head nuclear medicine gamma cameras used for cardiac imaging distributed worldwide. The recall cites potential detector mounting stress after End of Guaranteed Service. Hospitals should stop using these devices and follow the manufacturer’s recall instructions. Contact GE Medical Systems Israel Functional Imaging or a healthcare provider for guidance.

GE HealthCare
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Millenium MPR Gamma Camera Recalled for 292 Units Worldwide in 2025

GE HealthCare recalled 292 Millenium MPR dual-head gamma cameras worldwide after discovering some units past End of Guaranteed Service may have been transported without adequate detector support. This can place excessive stress on detector mounting and could result in a detector fall with life-threatening injury. Healthcare facilities should stop using the devices immediately and follow recall PIN

GE HealthCare
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies uEXPLORER MD PET/CT Recall for 2 Units in 2025

UIH Technologies recalled 2 uEXPLORER MD PET/CT systems after finding third-party outer covers can trap between the patient table and gantry. The interference can occur during table movement. Hospitals and healthcare facilities should stop using the devices and await instructions from UIH Technologies LLC.

UIH Technologies
Third-party outer
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Health & Personal Care
HIGH
FDA DEVICE

Shanghai United Imaging Healthcare uMI Panorama 35 MD PET/CT System Recalled for 4 Units (2025)

UIH Technologies LLC is recalling 4 Shanghai United Imaging Healthcare uMI Panorama 35 MD PET/CT systems sold in the United States. A third-party outer cover can become trapped between the patient table and gantry during table movement. Hospitals and clinics should stop using the devices and follow the manufacturer’s recall instructions.

Shanghai United Imaging Healthcare
Third-party outer
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Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies Recalls 2 uCT ATLAS MD CT X-ray Systems for Mechanical Interference Risk (2025)

UIH Technologies LLC recalled 2 units of the uCT ATLAS MD CT X-ray System sold to U.S. health care providers after reports of potential mechanical interference during table movement. The issue involves third-party outer covers that can become trapped between the patient table and gantry. Hospitals should stop using the devices immediately and follow recall instructions from UIH Technologies LLC.

UIH Technologies
Third-party outer
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Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Recalls 1,386 Millennium MG/MC Gamma Cameras for Detector Mounting Risk (2025)

GE HealthCare recalled 1,386 Millennium MG/MC dual-head gamma cameras used in cardiac imaging worldwide. The recall notes devices past End of Guaranteed Service may have been transported without adequate detector support, risking mounting failure and possible detector falls. Facilities should stop using the devices and await recall instructions sent by GE Medical Systems Israel, Functional Imaging

GE HealthCare
GE HealthCare
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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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Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies Recalls 11 uCT 760 MD CT Scanners for Cover Interference Risk (2025)

UIH Technologies recalled 11 units of the uCT 760 MD Computed Tomography X-ray System. Third-party outer covers can become trapped between the patient table and gantry, causing mechanical interference during table movement. Hospitals and patients should stop using the device immediately and await manufacturer instructions.

UIH Technologies
Third-party outer
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Health & Personal Care
HIGH
FDA DEVICE

Diagnostica Stago STA Liatest D-Di Recall 12,740 Units Worldwide in 2025

Diagnostica Stago recalled 12,740 STA Liatest D-Di units distributed worldwide after a potential risk of underestimating D-Dimer levels. The two listed lots may produce falsely low results. Stop using the devices immediately and follow recall instructions from Diagnostica Stago or your healthcare provider.

Diagnostica Stago
A potential
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Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Recalls 37 Maxicam Dual-Head Gamma Cameras for Cardiac Imaging (2025)

GE HealthCare Israel recalled 37 Maxicam dual-head gamma cameras distributed worldwide to hospitals. The recall cites potential detector mounting stress if the devices are moved without adequate support. This could result in a detector fall and life-threatening injury. Hospitals and healthcare providers should stop using the device and follow recall instructions from GE HealthCare.

GE HealthCare
GE HealthCare
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Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies uMI 550 MD PET/CT Recalled for 95 Units Over Mechanical Interference Risk (2025)

UIH Technologies LLC recalled 95 uMI 550 MD PET/CT systems sold in the United States after reports that third-party outer covers can become trapped between the patient table and gantry. The covers can interfere with table movement during imaging. Hospitals and clinics should stop using the devices and follow the manufacturer's recall instructions immediately.

UIH Technologies
Third-party outer
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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

UIH Technologies Recalls 8 Shanghai United Imaging uCT 530 MD CT Scanners Over Interference Risk (24

UIH Technologies LLC recalls eight Shanghai United Imaging uCT 530 MD CT scanners sold to U.S. hospitals. Third‑party outer covers can become trapped between the patient table and gantry, causing mechanical interference during table movement. Hospitals should stop using the device immediately and follow recall instructions from UIH Technologies or their healthcare provider.

Shanghai United Imaging Healthcare
Third-party outer
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Health & Personal Care
HIGH
FDA DEVICE

Shanghai United Imaging Healthcare CT X-ray System uCT 550 MD Recall for 22 Units in 2025

Shanghai United Imaging Healthcare recalled 22 CT X-ray systems, including the uCT 550 MD, sold to healthcare facilities in the United States. A third-party outer cover can become trapped between the patient table and gantry, causing mechanical interference during table movement. Stop using the device and follow the manufacturer’s recall instructions immediately.

Shanghai United Imaging Healthcare
Third-party outer
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Recalled In My Jammers Button Up Flare Set – Victoria print
HIGH
CPSC

In My Jammers Recalls Button Flare Pajama Sets for Burn Hazard in 2025

In My Jammers recalls children's button-up flare pajama sets sold online after the company violated mandatory flammability standards. The recall, active as of Sept. 11, 2025, involves sets in multiple prints and sizes. Parents should stop using them and seek a full refund or store credit.

In My Jammers
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA II BF-1T180 Bronchovideoscope Recall for IFU Update — 5,247 Units (2025)

Olympus Corporation of the Americas recalled 1,473 US units and 3,774 non-US units of the EVIS EXERA II bronchovideoscope BF-1T180. The recall concerns updated instructions for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Stop using the device immediately and follow manufacturer instructions.

Olympus
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific TENACIO Pump Recall 2025 for Inflation Deflation Issues

Boston Scientific recalled the TENACIO Pump without InhibiZone (UPN 72404420) worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.

Boston Scientific
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-P190 Bronchoscope Recall Updated for 2025 IFU Guidance

Olympus recalls 3,046 BF-P190 bronchovideoscopes sold nationwide in the US and 2,414 overseas. The recall centers on updated IFU guidance to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Clinicians and facilities should stop using the device immediately and follow Olympus recall instructions.

Olympus
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Insulet Omnipod 5 iOS App Recall Affects 174,013 Units in 2025

Insulet recalled 174,013 Omnipod 5 iOS app software units distributed nationwide in the United States. The recall cites a magnifying feature bug that can duplicate a single-digit entry. This could lead to bolus insulin dosing errors and hypoglycemia. Stop using the app immediately and follow recall instructions from Insulet or your healthcare provider.

Insulet
The failure
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