All Recalls | RecallPedia

Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343

Philips North America

🏥 Medical Devices Class I - Dangerous

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 3, 2024 Diagnostic Equipment Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350

Philips North America

🏥 Medical Devices Class I - Dangerous

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 3, 2024 Diagnostic Equipment Nationwide View Details →

Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342

Philips North America

🏥 Medical Devices Class I - Dangerous

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 3, 2024 Diagnostic Equipment Nationwide View Details →

Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual bleeding. The device is intended for use by healthcare professionals who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with endometrial ablation. The Cerene Device is single use, disposable, and provided sterile. The average procedure time is 7 minutes, with 2.5 minutes of active cryoablation. Ablation is achieved throughout the uterine cavity through the use of cryothermic energy. The cryothermic energy is provided by a liquid-to-gas phase change of N2O. During the 2.5-minute treatment cycle, liquid N2O (originating from a small Cylinder located in the device handle) flows through a delivery line and into an inflow line with multiple jets. This liquid N2O is infused into an ultra-thin polyurethane Liner, where it converts into gas. The gaseous N2O is exhausted through the Exhaust Hose exiting the bottom of the handle. Component: N/A

Channel Medsystems

🏥 Medical Devices Class I - Dangerous

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 3, 2024 Infusion Pumps Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.

Olympus Corporation of the Americas

🏥 Medical Devices Class I - Dangerous

Potential for distal end of the sheath to break off during a procedure.

Apr 3, 2024 Other Medical Devices Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class II - Moderate

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments View Details →

Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477

Philips North America

🏥 Medical Devices Class I - Dangerous

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 3, 2024 Diagnostic Equipment Nationwide View Details →

Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for single use Component: No

Jiangsu Shenli Medical Production Co.

🏥 Medical Devices Class I - Dangerous

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Apr 5, 2024 Surgical Instruments Nationwide View Details →