Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-12-16FDA-DeviceMani, Inc. - Kiyohara FacilityClass IIMANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
- 2020-12-16FDA-DeviceShimadzu Medical SystemsClass IIMH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
- 2020-12-16FDA-DeviceShimadzu Medical SystemsClass IITrinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
- 2020-12-16FDA-DeviceShimadzu Medical SystemsClass IIBransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
- 2020-12-16FDA-DeviceWELCH ALLYN, INC/MORTARAClass IIELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
The radio within the device can become disassociated with the wireless access point.
- 2020-12-16FDA-DeviceTissueTech, Inc.Class IIPROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
Potential exposure of product to microbial contamination.
- 2020-12-16FDA-DeviceTissueTech, Inc.Class IIPROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
Potential exposure of product to microbial contamination.
- 2020-12-16FDA-DeviceTissueTech, Inc.Class IIPROKERA, non-sterile - Product Usage: Biologic corneal bandage.
Potential exposure of product to microbial contamination.
- 2020-12-16FDA-DeviceCanon Medical System, USA, INC.Class IICanon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.
- 2020-12-16FDA-DeviceIntegra LifeSciences Corp.Class IIInstruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
- 2020-12-16FDA-DeviceRandox Laboratories Ltd.Class IIRandox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
- 2020-12-16FDA-DeviceRandox Laboratories Ltd.Class IIRandox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
- 2020-12-16FDA-DevicePhilips North America LlcClass IIPhilips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
- 2020-12-16FDA-DevicePhilips North America LlcClass IIPhilips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
- 2020-12-16FDA-DeviceGE Healthcare, LLCClass IIMAC VU360, Electrocardiograph
Incorrect patient identification and/or patient demographic errors.
- 2020-12-16FDA-DeviceK2M, IncClass IIEverest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195
All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks
- 2020-12-16FDA-DeviceClinical Innovations, LLCClass IIClinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.
- 2020-12-16FDA-DeviceAvanos Medical, Inc.Class IICORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Detachment of the Male AIV Adaptor from the Y-Connector.
- 2020-12-16FDA-DeviceChromsystems Instruments & Chemicals GmbHClass IIMassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
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- 2020-12-16FDA-DeviceChromsystems Instruments & Chemicals GmbHClass IIMassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
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- 2020-12-16FDA-DeviceChromsystems Instruments & Chemicals GmbHClass IIMassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Products do not meet stability criteria and may impact results.
- 2020-12-16FDA-DeviceChromsystems Instruments & Chemicals GmbHClass II3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Products do not meet stability criteria and may impact results.
- 2020-12-16FDA-DeviceLivaNova USA IncClass IIVNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
- 2020-12-16FDA-DeviceShimadzu Medical SystemsClass IIShimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
- 2020-12-09FDA-DeviceEthicon, Inc.Class IIPROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
- 2020-12-09FDA-DeviceCanon Medical System, USA, INC.Class IICAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.
- 2020-12-09FDA-DeviceVerathon, Inc.Class IIBladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Due to a change in handle material and process, probe handle may crack.
- 2020-12-09FDA-DeviceCME America, LLCClass IICME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
- 2020-12-09FDA-DeviceCME America, LLCClass IICME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
- 2020-12-09FDA-DeviceCME America, LLCClass IICME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
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