Medical Device Recalls

7,979 medical device recalls from federal enforcement feeds.

Showing 6,501–6,550 of 7,979

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PE

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class I

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J;

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ618

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Number DYNJSYCPP10Y ; 3) SYRINGE KIT , Pack Number NAM

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENT

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A;

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR &

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISI

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, P

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FL

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISION TRAY, Pack Number CIT6715; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT709

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 8, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT ,

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

  Class II

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 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 YELLOW NITRO Model/Catalog Number: 91852 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 WHITE CONTRAST Model/Catalog Number: 91860 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

  Randox Laboratories Ltd.

  Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

  Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.

  Class III

• Medical Device Recall · April 5, 2024

  Jiangsu Shenli Medical Production Co., Ltd.

  Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-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: 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 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

  GE Healthcare Finland Oy

  CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 55

  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: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-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: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR06L Product Description: NON-Sterile syringes without needles for single use Co

  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 3ML/LL syringe Model/Catalog Number: TS2203L-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 B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441

  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 10ML L/L CONTROL Model/Catalog Number: 91881 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 - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR01L Serial Number: 850007185411 Product Descripti

  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 20ML/LL syringe Model/Catalog Number: TS2220L-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

  GE Healthcare Finland Oy

  CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

  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 CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 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 Model/Catalog Number: 83081 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 WHITE HEP FLUSH Model/Catalog Number: 91862 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 A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437

  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: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-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 3ML L/L BLUE Model/Catalog Number: 91822 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/S Model/Catalog Number: 83083 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 Model/Catalog Number: 91834 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 Model/Catalog Number: 91837 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 12ML/LL syringe Model/Catalog Number: TS2212L-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 1ML TB Model/Catalog Number: 83089 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 SALINE Model/Catalog Number: 91849 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 GREEN Model/Catalog Number: 91821 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 5ML/LL syringe Model/Catalog Number: TS2205L-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 BLUE Model/Catalog Number: 91880 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 Model/Catalog Number: 91841 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 A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439

  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 5ML L/L YELLOW Model/Catalog Number: 91829 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