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.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10053, d) DLP¿ Suction Tube 10 Fr. Shaft with 20 Fr. Pool Tip, Model Number: 10060, e) DLP¿ Suction Tube 16 Fr. Shaft with 20 Fr. Fluted Tip, Model Number: 10061
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP¿ Perfusion/Venting Adapter, Model Number 13002, g) DLP¿ Y Adapter
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP¿ Pericardial Sump 38
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic DLP Coronary Ostial Cannulae, Model Number 30050
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Clearview Blower/Mister, Model Number 22120
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 87120; e) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLP¿ Curved Tip Art
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceTriMed Inc.Class IITriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
- 2024-05-22FDA-DeviceTriMed Inc.Class IITriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
- 2024-05-22FDA-DeviceOssur H / FClass IIRKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- 2024-05-22FDA-DeviceOssur H / FClass IIRKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- 2024-05-22FDA-DeviceOssur H / FClass IIRKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- 2024-05-22FDA-DeviceOssur H / FClass IIRKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- 2024-05-22FDA-DeviceBoston Scientific CorporationClass IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
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