April 30, 2025Medical DevicesFDA
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Hazard: When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
April 30, 2025Medical DevicesFDA
IHB OPERATIONS B.V. recalls Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Hazard: The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.
April 30, 2025Medical DevicesFDA
Philips North America Llc recalls Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Hazard: Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
April 30, 2025Medical DevicesFDA
Radiometer Medical ApS recalls Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX
Hazard: ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.
April 30, 2025Medical DevicesFDA
Edge Biologicals Inc recalls Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making d
Hazard: Due to product outer packaging incorrectly labeled.
April 30, 2025Medical DevicesFDA
Globus Medical, Inc. recalls MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Hazard: Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
April 30, 2025Medical DevicesFDA
Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software v
Hazard: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
April 30, 2025Medical DevicesFDA
Tornier, Inc recalls stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Se
Hazard: A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
April 30, 2025Medical DevicesFDA
Medtronic MiniMed, Inc. recalls InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Hazard: Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.
April 30, 2025Medical DevicesFDA
Zimmer, Inc. recalls Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained
Hazard: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
April 30, 2025Medical DevicesFDA
Zimmer, Inc. recalls Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained
Hazard: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
April 30, 2025Medical DevicesFDA
Zimmer, Inc. recalls Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained
Hazard: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
April 30, 2025Medical DevicesFDA
Zimmer, Inc. recalls Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constr
Hazard: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
April 30, 2025Medical DevicesFDA
Zimmer, Inc. recalls Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constr
Hazard: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
April 30, 2025Medical DevicesFDA
Abbott recalls Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Hazard: Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
April 30, 2025Medical DevicesFDA
Abbott recalls Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Hazard: Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
April 30, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca
Hazard: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
April 30, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Hazard: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
April 30, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-
Hazard: Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.
April 30, 2025Medical DevicesFDA
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED,
Hazard: Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
April 30, 2025Medical DevicesFDA
Maquet Cardiovascular, LLC recalls The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len
Hazard: There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.
April 30, 2025Medical DevicesFDA
Conavi Medical Inc. recalls Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product
Hazard: Due to manufacturing issues there is a potential for the catheter sheath to detach.
April 30, 2025Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as w
Hazard: Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
April 30, 2025Medical DevicesFDA
Philips North America Llc recalls Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic,
Hazard: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
April 30, 2025Medical DevicesFDA
Philips North America Llc recalls Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, in
Hazard: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
April 30, 2025Medical DevicesFDA
Philips North America Llc recalls Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, i
Hazard: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.