Medical device recalls
39137 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-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
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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