Medical DeviceJul 15, 2020
TeDan Surgical Innovations PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX recall — FDA Z-2530-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
July 2020 recalls — page 13
These records include useful source details for the selected month.
Medical DeviceJul 15, 2020
CRHF Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 recall — FDA Z-2512-2020
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e.,…
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceJul 15, 2020
Philips EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic recall — FDA Z-2523-2020
Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceJul 15, 2020
Kentec Medical Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes recall — FDA Z-2519-2020
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until…
Class IIFDA: TerminatedKentec Medical, Inc.
Medical DeviceJul 15, 2020
TeDan Surgical Innovations PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product recall — FDA Z-2527-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceJul 15, 2020
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for recall — FDA Z-2534-2020
Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
Class IIFDA: TerminatedDufner Instrumente GmbH
Medical DeviceJul 15, 2020
Shanghai United Imaging Healthcare Co uDR 596i Digital Medical X-Ray Imaging System recall — FDA Z-2521-2020
Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care.…
Class IIFDA: TerminatedShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceJul 15, 2020
Abbott TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 recall — FDA Z-2541-2020
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
Class IIFDA: TerminatedAbbott
Medical DeviceJul 15, 2020
CRHF Patient Connector, Model Number 24967 recall — FDA Z-2506-2020
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e.,…
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceJul 15, 2020
CRHF Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 recall — FDA Z-2509-2020
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e.,…
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceJul 15, 2020
Kentec Medical Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes recall — FDA Z-2515-2020
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until…
Class IIFDA: TerminatedKentec Medical, Inc.
Medical DeviceJul 15, 2020
Kentec Medical Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes recall — FDA Z-2514-2020
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until…
Class IIFDA: TerminatedKentec Medical, Inc.
Medical DeviceJul 15, 2020
CRHF Azure S SR MRI, Model Number W3SR01 recall — FDA Z-2510-2020
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e.,…
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceJul 15, 2020
Capso Vision The CapsoCam Plus (SV-3) recall — FDA Z-2536-2020
Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis…
Class IIFDA: TerminatedCapso Vision, Inc.
Medical DeviceJul 15, 2020
CRHF Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 recall — FDA Z-2507-2020
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e.,…
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceJul 15, 2020
Radiometer Medical ApS Blood gases (PCO2, PO2) and blood pH test system recall — FDA Z-2494-2020
Potential risk of patient mix-up on analyzers due to software issues.
Class IIFDA: TerminatedRadiometer Medical ApS
Medical DeviceJul 15, 2020
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems recall — FDA Z-2543-2020
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceJul 15, 2020
CRHF Azure S DR MRI, Model Number W3DR01 recall — FDA Z-2508-2020
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e.,…
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceJul 15, 2020
CRHF CareLink SmartSync Device Manager, Model Number 24970A recall — FDA Z-2505-2020
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e.,…
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceJul 15, 2020
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and recall — FDA Z-2540-2020
An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD…
Class IIFDA: TerminatedFHC, Inc.
Medical DeviceJul 15, 2020
Verathon GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the recall — FDA Z-2476-2020
When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI…
Class IFDA: TerminatedVerathon, Inc.
Medical DeviceJul 15, 2020
Kentec Medical Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes recall — FDA Z-2518-2020
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until…
Class IIFDA: TerminatedKentec Medical, Inc.
Medical DeviceJul 15, 2020
TeDan Surgical Innovations PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX recall — FDA Z-2528-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceJul 15, 2020
CRHF Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 recall — FDA Z-2511-2020
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e.,…
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.