Skip to content
Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 35 of 1581

Evidence Product Join Root cause
device-recall:cfres:210016 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral vascular imaging catheter, the system utilizes the IVUS modality for ultrasound examination of intravascular pathology. Official recall number · Z-0112-2025 Under Investigation by firm
device-recall:cfres:206584 TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D Official recall number · Z-1623-2024 Under Investigation by firm
device-recall:cfres:206759 VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721 Official recall number · Z-1464-2024 Employee error
device-recall:cfres:206732 Intera CV, Magnetic Resonance System. Official recall number · Z-1586-2024 Process design
device-recall:cfres:205409 Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E Official recall number · Z-1542-2024 Process control
device-recall:cfres:206777 Dr¿ger Perseus A500 Anesthesia Workstation Official recall number · Z-1512-2024 Labeling design
device-recall:cfres:206606 PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143 Official recall number · Z-1507-2024 Software design
device-recall:cfres:206547 Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490 Official recall number · Z-1527-2024 Under Investigation by firm
device-recall:cfres:206876 Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00; e) POWER CORD,EUROPEAN,2.5A,250V,2.5M,C7, 008-0912-00; f) LINE CORD (EURO), 4500-402; g) LINE CORD (UK), 4500-404; h) LINE CORD (AUS), 4500-406 Official recall number · Z-1511-2024 Nonconforming Material/Component
device-recall:cfres:206546 Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377 Official recall number · Z-1526-2024 Under Investigation by firm
device-recall:cfres:207357 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d. 20mL Oral Syringe Amber NonSterile, Product Code BA-S20EO; e. 35mL Oral Syringe Amber NonSterile, Product Code BA-S35EO; f. 3mL Oral Syringe Amber NonSterile, Product Code BA-S3EO; g. 60mL Oral Syringe Amber NonSterile, Product Code BA-S60EO; h. 6mL Oral Syringe Amber NonSterile, Product Code BA-S6EO; Official recall number · Z-2035-2024 Under Investigation by firm
device-recall:cfres:207678 HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411 Official recall number · Z-1948-2024 Under Investigation by firm
device-recall:cfres:207746 ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Official recall number · Z-1956-2024 Equipment maintenance
device-recall:cfres:207793 ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Official recall number · Z-1998-2024 Equipment maintenance
device-recall:cfres:207754 ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Official recall number · Z-1964-2024 Equipment maintenance
device-recall:cfres:206751 Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 Official recall number · Z-2030-2024 No Marketing Application
device-recall:cfres:207620 Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC Official recall number · Z-2033-2024 No Marketing Application
device-recall:cfres:207795 ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Official recall number · Z-1999-2024 Equipment maintenance
device-recall:cfres:207856 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 Official recall number · Z-2080-2024 No Marketing Application
device-recall:cfres:207843 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 Official recall number · Z-2067-2024 No Marketing Application
device-recall:cfres:207542 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. Official recall number · Z-1888-2024 Under Investigation by firm
device-recall:cfres:207307 Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump Official recall number · Z-1811-2024 Device Design
device-recall:cfres:207337 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 Official recall number · Z-1889-2024 Device Design
device-recall:cfres:207157 EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 Official recall number · Z-1833-2024 Nonconforming Material/Component
device-recall:cfres:207393 Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359 Official recall number · Z-1850-2024 Under Investigation by firm

Field note

Send feedback

We'll only use this to respond to your feedback.