Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-10-13FDA-DeviceDatascope Corp.Class IICardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
- 2021-10-13FDA-DeviceDatascope Corp.Class IICardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
- 2021-10-13FDA-DeviceDePuy Orthopaedics, Inc.Class IIATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
- 2021-10-13FDA-DeviceAngiodynamics, Inc.Class IIAngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
- 2021-10-13FDA-DeviceInnovative Orthopedic Technologies, LLCClass IIARCH Leg Positioning System
Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
- 2021-10-13FDA-DevicePhilips Ultrasound IncClass IIPhilips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
- 2021-10-13FDA-DevicePhilips Ultrasound IncClass IIPhilips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
- 2021-10-13FDA-DeviceCardioQuip, LLCClass IICardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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