Safety Recall Directory
Browse and filter the latest official safety alerts globally.
CPSCBISSELL Recalls Over One Million Steam Shot OmniReach Steam Cleaners Due to Risk of Serious Burn Hazard from Attachments
BISSELL Recalls Over One Million Steam Shot OmniReach Steam Cleaners Due to Risk of Serious Burn Hazard from Attachments
The recalled steam cleaners' attachments can unexpectedly detach from the steam cleaners and expel hot water or steam onto users during use, posing a serious burn hazard.
CPSCSCUBAPRO Recalls Monorail Weight Pockets for Buoyancy Compensator Devices (BCDs) Due to Risk of Serious Injury or Death from Drowning
SCUBAPRO Recalls Monorail Weight Pockets for Buoyancy Compensator Devices (BCDs) Due to Risk of Serious Injury or Death from Drowning
The D-ring handle that is used to unlock the weight pocket from the Buoyancy Compensator Device (BCD) can detach during use. If this happens, the user will not be able to remove the weight pocket in an emergency, in order to rise to the surface, posing a risk of serious injury or death from a drowning hazard.
CPSCEasymake Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails; Imported by ZFZG-US
Easymake Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails; Imported by ZFZG-US
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
FDA DevicesBrand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA
Potential for the balloon in the device to not meet burst specifications.
FDA DevicesPhilips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
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 DevicesBrand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Due to increased complaints for broken/frayed grip cables for reusable instruments.
FDA DevicesMedline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
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 DevicesBrand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A
Due to increased complaints for broken/frayed grip cables for reusable instruments.
FDA DevicesAzurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (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 DevicesBlue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
FDA DevicesMiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
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 DevicesPhilips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
FDA DevicesMedline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B 7. LEX THORACIC, DYNJ902016K DYNJ902016L 8. ORGAN PROCUREMENT, DYNJ908686 9. PULMONARY PACK, DYKE1859 10. THORACIC, DYNJ901666L 11. THORACIC ROBOTICS, DYNJ908777A 12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O 13. XPS, DYNJ907605
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B 7. LEX THORACIC, DYNJ902016K DYNJ902016L 8. ORGAN PROCUREMENT, DYNJ908686 9. PULMONARY PACK, DYKE1859 10. THORACIC, DYNJ901666L 11. THORACIC ROBOTICS, DYNJ908777A 12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O 13. XPS, DYNJ907605
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 DevicesPurge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).
Increased risk of purge leaks with Generation 1 purge cassettes.
FDA DevicesPhilips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
FDA DevicesAzurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (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 DevicesArtoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
FDA DevicesMiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
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 DevicesAllura Xper FD20/20 OR Table; System Code: 722039;
Allura Xper FD20/20 OR Table; System Code: 722039;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA DevicesParadigm Insulin Pump (MMT-712, MMT-715)
Paradigm Insulin Pump (MMT-712, MMT-715)
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.
RappelConsosimulation réaliste en peluche chien intelligent appelé marche en peluche jouet électrique jouet souple
simulation réaliste en peluche chien intelligent appelé marche en peluche jouet électrique jouet souple
les piles peuvent surchauffer si les parties mobiles du jouet mou (jambes et tête) sont obstruées pendant l'utilisation standard, ce qui peut causer des brûlures aux utilisateurs.
FDA DevicesCPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
FDA DevicesArtoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.