Medical Device Recalls

7,979 medical device recalls from federal enforcement feeds.

Showing 6,551–6,600 of 7,979

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  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

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use C

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  GE Healthcare Finland Oy

  CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-0105

  GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  IVOCLAR VIVADENT AG

  IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443

  Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  GE Healthcare Finland Oy

  CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2

  GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  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

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for single usef Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  GE Healthcare Finland Oy

  CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01

  GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for single use Component: No

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

  Class II