February 28, 2024Medical DevicesFDA
Canon Medical System, USA, INC. recalls The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A
Hazard: VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
February 28, 2024Medical DevicesFDA
Canon Medical System, USA, INC. recalls The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional
Hazard: VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
February 28, 2024Medical DevicesFDA
Boston Scientific Corporation recalls EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Hazard: Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
February 28, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected
Hazard: Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
February 28, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected
Hazard: Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
February 28, 2024Medical DevicesFDA
B. Braun Medical, Inc. recalls Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of device
Hazard: Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
February 28, 2024Medical DevicesFDA
B. Braun Medical, Inc. recalls Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass
Hazard: Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
February 28, 2024Medical DevicesFDA
AMD Medicom Inc. recalls PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Hazard: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
February 28, 2024Medical DevicesFDA
AMD Medicom Inc. recalls HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Hazard: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
February 28, 2024Medical DevicesFDA
AMD Medicom Inc. recalls HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Hazard: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
February 28, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected
Hazard: Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
February 28, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected
Hazard: Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
February 28, 2024Medical DevicesFDA
Voco GmbH recalls Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Hazard: Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
February 28, 2024Medical DevicesFDA
Voco GmbH recalls IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Hazard: Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
February 28, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Hazard: Sterility assurance for saline included in surgical kits cannot be guaranteed.
February 28, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Hazard: Sterility assurance for saline included in surgical kits cannot be guaranteed.
February 28, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Hazard: Sterility assurance for saline included in surgical kits cannot be guaranteed.
February 28, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Hazard: Sterility assurance for saline included in surgical kits cannot be guaranteed.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATE
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 4
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILIC
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML B
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls TRACH KIT W/HYDROGEN & SALI
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chi
Hazard: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
February 28, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Exactamix Pro 2400, REF EXM24DY
Hazard: An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
February 28, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Exactamix Pro 1200, REF EXM12DY
Hazard: An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.