May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes w
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Channel Medsystems, Inc. recalls Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-70
Hazard: Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).
May 29, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid en
Hazard: Potential for distal end of the sheath to break off during a procedure.
May 29, 2024Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
Hazard: The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.
May 29, 2024Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
Hazard: The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.
May 29, 2024Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution
Hazard: Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
May 29, 2024Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Hazard: AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
May 29, 2024Medical DevicesFDA
Tornier S.A.S. recalls Stryker Blueprint Software, Catalog #BPUE001.
Hazard: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
May 29, 2024Medical DevicesFDA
Cadwell Industries Inc recalls Cascade IOMAX Cortical Module, REF: 190296-200
Hazard: There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
May 29, 2024Medical DevicesFDA
Ethicon, Inc. recalls SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Hazard: Some applicator tips from these lots had open seals.
May 29, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Hazard: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
May 29, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Hazard: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
May 29, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Nu
Hazard: Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728
Hazard: Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728
Hazard: Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 29, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Blood Pump Rotor, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devic
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a d
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use a
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls SmartPath to dStream for 3.0T Model Number (REF): 782145
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a dia
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire