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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 29 of 1581

Evidence Product Join Root cause
device-recall:cfres:215788 Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; Official recall number · Z-2627-2025 Device Design
device-recall:cfres:215148 ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube. Official recall number · Z-2484-2025 Process design
device-recall:cfres:215629 Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit. Official recall number · Z-2530-2025 Nonconforming Material/Component
device-recall:cfres:214086 LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring. Official recall number · Z-2498-2025 Under Investigation by firm
device-recall:cfres:215517 Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing. Official recall number · Z-2510-2025 Under Investigation by firm
device-recall:cfres:215509 RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Planning System. Official recall number · Z-2495-2025 Under Investigation by firm
device-recall:cfres:215006 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System Official recall number · Z-2447-2025 Software design
device-recall:cfres:215809 Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; Official recall number · Z-0005-2026 Device Design
device-recall:cfres:215853 Biograph mMR. Model Number: 10433372. Official recall number · Z-2654-2025 Under Investigation by firm
device-recall:cfres:215821 AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. Official recall number · Z-0027-2026 Process control
device-recall:cfres:215812 Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; Official recall number · Z-0008-2026 Device Design
device-recall:cfres:215854 BIOGRAPH One (DE). Model Number: 11689172. Official recall number · Z-2655-2025 Under Investigation by firm
device-recall:cfres:215108 Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump Official recall number · Z-2332-2025 Software design (manufacturing process)
device-recall:cfres:215097 STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. Official recall number · Z-2475-2025 Mixed-up of materials/components
device-recall:cfres:215328 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G; Official recall number · Z-2465-2025 Under Investigation by firm
device-recall:cfres:215158 Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component Official recall number · Z-2421-2025 Under Investigation by firm
device-recall:cfres:215347 WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. Official recall number · Z-2431-2025 Under Investigation by firm
device-recall:cfres:215482 Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump Official recall number · Z-2334-2025 Software design (manufacturing process)
device-recall:cfres:215000 Orascoptic Superior Visualization Custom loupes with Dragonfly frames Official recall number · Z-2440-2025 Labeling design
device-recall:cfres:214316 Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S Official recall number · Z-2462-2025 Process design
device-recall:cfres:215248 X11-4t Transducer Probe Official recall number · Z-2406-2025 Device Design
device-recall:cfres:215249 X3-1 Transducer Probe Official recall number · Z-2407-2025 Device Design
device-recall:cfres:215251 X5-1c Transducer Probe Official recall number · Z-2409-2025 Device Design
device-recall:cfres:215113 Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No Official recall number · Z-2417-2025 Process control
device-recall:cfres:214671 Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 Official recall number · Z-2294-2025 Process control

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