Medical device recalls
39048 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-09-18FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- 2024-09-18FDA-DevicePACIFIC LASERTECH, LLCClass IIN-LHP-928, HeNe Laser System, 35 mW
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
- 2024-09-18FDA-DevicePACIFIC LASERTECH, LLCClass II25-LHP-928, HeNe Laser System, 25 mW
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
- 2024-09-18FDA-DevicePACIFIC LASERTECH, LLCClass II25-LHP-828, HeNe Laser System, 35 mW
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
- 2024-09-18FDA-DeviceSmiths Medical ASD Inc.Class IPneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
- 2024-09-18FDA-DeviceSmiths Medical ASD Inc.Class IPneupac paraPAC plus 300 ventilator kit, REF P300NXX
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
- 2024-09-18FDA-DeviceB Braun Medical IncClass IInfusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.
- 2024-09-18FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
- 2024-09-18FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
- 2024-09-11FDA-DeviceBeckman Coulter Biomedical GmbHClass IIPE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
- 2024-09-11FDA-DeviceBeckman Coulter Biomedical GmbHClass IIPE Centrifuge, REF: B36365, a component of the Power Express
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
- 2024-09-11FDA-DeviceBeckman Coulter Biomedical GmbHClass IIPower Express, REF B90918
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella CP Smart Assist Set; Product Code: 1000402;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella 5.5 Set AU; Product Code: 1000361;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella 5.5 SmartAssist Set, JP; Product Code: 1000211;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIPump 381 Pump Set (US); Product Code: 1000080;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella CP Smart Assist Set APAC; Product Code: 0048-0047;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIPump 371 14F LT CMR Set; Product Code: 0048-0045;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella CP Smart Assist Set, Canada; Product Code: 0048-0044;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella CP Pump Set, Japan; Product Code: 0048-0034-JP;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- 2024-09-11FDA-DeviceAbiomed, Inc.Class IIImpella CP Smart Assist Set, EU; Product Code: 0048-0014;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
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