Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesRefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
FDA DevicesMiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
FDA DevicesJiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
FDA DevicesBurlington Medical, Kilt Blockers.
Burlington Medical, Kilt Blockers.
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesALLURA Xper FD10F; System Code: 722002;
ALLURA Xper FD10F; System Code: 722002;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesAzurion 5 M12; System Code: (1)722227, (2)722231;
Azurion 5 M12; System Code: (1)722227, (2)722231;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DeviceseTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
FDA DevicesMedline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
FDA DevicesCPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
FDA DevicesBurlington Medical, Demi Half Aprons.
Burlington Medical, Demi Half Aprons.
Potential for attenuation degradation over time, decreasing the lifespan.
FDA DevicesBurlington Medical, Protective Sleeves.
Burlington Medical, Protective Sleeves.
Potential for attenuation degradation over time, decreasing the lifespan.
NHTSAForest River, Inc. - Incorrect Weight Listed on Label/FMVSS 110
Forest River, Inc. - Incorrect Weight Listed on Label/FMVSS 110
Incorrect weight information may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
NHTSAToyota Motor Engineering & Manufacturing - Fuel Pump May Fail
Toyota Motor Engineering & Manufacturing - Fuel Pump May Fail
Fuel pump failure can cause an engine stall, increasing the risk of a crash.
FDA DrugstraMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
FDA DevicesAzurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesBrand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
FDA DevicesENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
FDA DevicesCPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
FDA DevicesMiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
FDA FoodImu-Tek Colostrum-5 120 Capsules; 30% IgG, 2 capsules 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band seal, 500 mg capsule, 7 38654 00026 7, Imu-Tek, Inc. Ft. Collins, CO 80524.
Imu-Tek Colostrum-5 120 Capsules; 30% IgG, 2 capsules 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band seal, 500 mg capsule, 7 38654 00026 7, Imu-Tek, Inc. Ft. Collins, CO 80524.
Product is potentially under-processed.
FDA FoodPOPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ
POPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
FDA FoodImu-Tek Colostrum-5 Powder; 30% IgG,1,000 mg 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band exterior seal, 24 ounces (680 grams) powder, 7 38654 00052 6, ImuTek Laboratories, Fort Collins, CO 80524.
Imu-Tek Colostrum-5 Powder; 30% IgG,1,000 mg 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band exterior seal, 24 ounces (680 grams) powder, 7 38654 00052 6, ImuTek Laboratories, Fort Collins, CO 80524.
Product is potentially under-processed.
Health CanadaTransport Canada Recall - 2026147 - MERCEDES-BENZ
Transport Canada Recall - 2026147 - MERCEDES-BENZ
Airbag