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 11 of 1581

Evidence Product Join Root cause
device-recall:cfres:183430 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. Official recall number · Z-0036-2021 Under Investigation by firm
device-recall:cfres:182903 ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿ Official recall number · Z-2851-2020 Nonconforming Material/Component
device-recall:cfres:182923 ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿ Official recall number · Z-2871-2020 Nonconforming Material/Component
device-recall:cfres:182622 Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes. Official recall number · Z-2829-2020 Under Investigation by firm
device-recall:cfres:182547 VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only. Official recall number · Z-2770-2020 Process control
device-recall:cfres:182596 Tibial knee prosthesis Official recall number · Z-2774-2020 Nonconforming Material/Component
device-recall:cfres:182244 Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure gradients. To facilitate complete lung re-expansion to restore normal breathing dynamics. Official recall number · Z-2749-2020 Under Investigation by firm
device-recall:cfres:182139 Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. Official recall number · Z-2735-2020 Software design
device-recall:cfres:182415 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop. Official recall number · Z-2760-2020 Device Design
device-recall:cfres:182135 Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system Official recall number · Z-2723-2020 Device Design
device-recall:cfres:182683 Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications Official recall number · Z-2848-2020 Device Design
device-recall:cfres:181994 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Official recall number · Z-2836-2020 Process change control
device-recall:cfres:182996 Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site. Official recall number · Z-2818-2020 Process control
device-recall:cfres:182027 Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Official recall number · Z-2843-2020 Process change control
device-recall:cfres:182163 Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. Official recall number · Z-2825-2020 Device Design
device-recall:cfres:182905 ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿ Official recall number · Z-2853-2020 Nonconforming Material/Component
device-recall:cfres:180937 Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. Official recall number · Z-2819-2020 Software design
device-recall:cfres:181907 SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439) Official recall number · Z-2664-2020 Process control
device-recall:cfres:181921 BodyGuard Microset with Filter, REF: A100-163XESF Official recall number · Z-2564-2020 Device Design
device-recall:cfres:181702 EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 813845021020 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process. Official recall number · Z-2609-2020 Under Investigation by firm
device-recall:cfres:181926 CMExpress Microbore Set, REF: A120-161CYF Official recall number · Z-2569-2020 Device Design
device-recall:cfres:181942 Standard BodySet with Needleless Connectors, REF: A120-125XS Official recall number · Z-2585-2020 Device Design
device-recall:cfres:181928 BodyGuard Microset with Filter, REF: A120-160XSFE Official recall number · Z-2571-2020 Device Design
device-recall:cfres:197252 Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 Official recall number · Z-0740-2023 Under Investigation by firm
device-recall:cfres:197273 Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis. Official recall number · Z-0761-2023 Process change control