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.
- 2021-06-02FDA-DevicePhilips Respironics, Inc.Class IIBiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
- 2021-06-02FDA-DevicePhilips Respironics, Inc.Class IIBiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
- 2021-06-02FDA-DevicePhilips Respironics, Inc.Class IIBiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741147521 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036016 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035996 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035989 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceBard Access Systems Inc.Class IIREF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed.
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
- 2021-05-26FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II10 GAUGE DRILL, CODE INTVM-DRL
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class II11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
Products labeled as sterile were distributed, but may not have been sterilized.
- 2021-05-26FDA-DeviceBIOPSYBELL S.R.L.Class IICEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS
Products labeled as sterile were distributed, but may not have been sterilized.
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