Medical DeviceJul 3, 2024
Philips SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging recall — FDA Z-2164-2024
Potential for coils to heat up and harm patients (burn).
Class IFDA: OngoingPhilips North America LLC
July 2024 recalls — page 12
These records include useful source details for the selected month.
Medical DeviceJul 3, 2024
Medtronic COBALT XT HF CRT-D MRI SureScan recall — FDA Z-2191-2024
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJul 3, 2024
ASPEN SURGICAL Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt recall — FDA Z-2221-2024
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
Class IIFDA: CompletedASPEN SURGICAL
Medical DeviceJul 3, 2024
Medtronic MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter recall — FDA Z-2204-2024
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJul 3, 2024
Merit Medical Systems Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP recall — FDA Z-2218-2024
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJul 3, 2024
Medtronic PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter recall — FDA Z-2200-2024
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJul 3, 2024
Dental EZ Group Star Dental Division Titan Scaler Tip - Perio recall — FDA Z-2177-2024
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
Class IIFDA: OngoingDental EZ Group Star Dental Division
Medical DeviceJul 3, 2024
Draeger Medical Systems Infinity Acute Care System (IACS) Monitoring System, Infinity M500 recall — FDA Z-2189-2024
Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include…
Class IIFDA: OngoingDraeger Medical Systems, Inc.
Medical DeviceJul 3, 2024
Medtronic COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter recall — FDA Z-2208-2024
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJul 3, 2024
NovaSignal NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA recall — FDA Z-2216-2024
Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
Class IIFDA: OngoingNovaSignal Corp.
Medical DeviceJul 3, 2024
Siemens Medical Solutions USA MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X recall — FDA Z-2186-2024
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceJul 3, 2024
Philips SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging recall — FDA Z-2163-2024
Potential for coils to heat up and harm patients (burn).
Class IFDA: OngoingPhilips North America LLC
Medical DeviceJul 3, 2024
GE Healthcare Finland Oy CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) recall — FDA Z-2171-2024
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650…
Class IIFDA: OngoingGE Healthcare Finland Oy
Medical DeviceJul 3, 2024
Baxter Healthcare Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the recall — FDA Z-2140-2024
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 3, 2024
Medtronic MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter recall — FDA Z-2202-2024
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJul 3, 2024
GE Healthcare Finland Oy CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) recall — FDA Z-2172-2024
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650…
Class IIFDA: OngoingGE Healthcare Finland Oy
Medical DeviceJul 3, 2024
Integra LifeSciences CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical recall — FDA Z-2167-2024
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
Class IIFDA: OngoingIntegra LifeSciences Corp.
Medical DeviceJul 3, 2024
Sight OLO CBC Test Kit recall — FDA Z-2173-2024
One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test…
Class IIFDA: OngoingSIGHT DIAGNOSTICS LTD
Medical DeviceJul 3, 2024
Medtronic CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter recall — FDA Z-2211-2024
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJul 3, 2024
Medtronic COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter recall — FDA Z-2207-2024
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJul 3, 2024
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System recall — FDA Z-2219-2024
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
Class IIFDA: OngoingStryker GmbH
Medical DeviceJul 3, 2024
Mermaid Medical A/S The D*Clot HD Rotational Thrombectomy System is a percutaneous recall — FDA Z-2213-2024
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Class IIFDA: OngoingMermaid Medical A/S
Medical DeviceJul 3, 2024
Siemens Healthcare Diagnostics Software version 5.3 in: RAPIDPoint 500e Blood Gas System recall — FDA Z-2214-2024
Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary…
Class IIFDA: OngoingSiemens Healthcare Diagnostics Inc.
Medical DeviceJul 3, 2024
Siemens Medical Solutions USA AXIOM Vertix MD - The Vertix MD Trauma has been specially recall — FDA Z-2184-2024
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
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.