Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-02-28FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/1
Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
- 2024-02-28FDA-DeviceCanon Medical System, USA, INC.Class IIThe INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.
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.
- 2024-02-28FDA-DeviceCanon Medical System, USA, INC.Class IIThe device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
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.
- 2024-02-28FDA-DeviceBoston Scientific CorporationClass IIEndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
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.
- 2024-02-28FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
- 2024-02-28FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplan
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
- 2024-02-28FDA-DeviceB. Braun Medical, Inc.Class IIEpidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for in
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.
- 2024-02-28FDA-DeviceB. Braun Medical, Inc.Class IIEpidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. Product Code: 332079
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.
- 2024-02-28FDA-DeviceAMD Medicom Inc.Class IIPATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- 2024-02-28FDA-DeviceAMD Medicom Inc.Class IIHENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- 2024-02-28FDA-DeviceAMD Medicom Inc.Class IIHENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- 2024-02-28FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
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.
- 2024-02-28FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10
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.
- 2024-02-28FDA-DeviceVoco GmbHClass IIIonolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
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.
- 2024-02-28FDA-DeviceVoco GmbHClass IIIonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
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.
- 2024-02-28FDA-DeviceWindstone Medical Packaging, Inc.Class IAligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Sterility assurance for saline included in surgical kits cannot be guaranteed.
- 2024-02-28FDA-DeviceWindstone Medical Packaging, Inc.Class IAligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Sterility assurance for saline included in surgical kits cannot be guaranteed.
- 2024-02-28FDA-DeviceWindstone Medical Packaging, Inc.Class IAligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Sterility assurance for saline included in surgical kits cannot be guaranteed.
- 2024-02-28FDA-DeviceWindstone Medical Packaging, Inc.Class IAligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Sterility assurance for saline included in surgical kits cannot be guaranteed.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass IDover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass IDover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass IDover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2-WAY; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY INSERTION TRAY, 5 CC, PREP TRAY, 16 FR (5.3 MM); Dover"
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass IDover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass IDover" 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 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UN
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass IDover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 18FR (6.0 MM), 5CC, CSD; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 14 FR (4.7 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DR
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass IDover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML SYRINGE; Dover HYDROGEL COATED LATEX FOLEY TRAY 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICO
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass IDover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dove
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass ITRACH KIT W/HYDROGEN & SALI
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceCardinal Health 200, LLCClass IArgyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Sterile Saline 8 Fr/Ch (2.67 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 10 Fr/Ch (3.33 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, Towel 14 Fr/Ch (4.67 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 14
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-28FDA-DeviceBaxter Healthcare CorporationClass IBaxter Exactamix Pro 2400, REF EXM24DY
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.
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