Class IIOngoingZ-2501-2025
Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter
Due to products distributed without premarket clearance or approvals.
Visgeneer, Inc.Sep 10, 2025
Recalls: No Marketing Application
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 217–228 of 228 recalls
Class IIOngoingZ-2500-2025
Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter
Due to products distributed without premarket clearance or approvals.
Visgeneer, Inc.Sep 10, 2025
Class IITerminatedZ-2298-2025
Insightra Medical Inc recalls Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catal…
Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.
Insightra Medical IncTNAug 20, 2025
Class IIOngoingZ-2033-2025
Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
Jewel Precision Sheet…NJJul 2, 2025
Class IIOngoingZ-2026-2025
Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP…
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Jewel Precision Sheet…NJJul 2, 2025
Class IIOngoingZ-1979-2025
Guangzhou Pluslife Biotech Co., Ltd. recalls Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Car…
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Guangzhou Pluslife Bio…Jun 25, 2025
Class IIOngoingZ-1978-2025
Guangzhou Pluslife Biotech Co., Ltd. recalls Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catal…
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Guangzhou Pluslife Bio…Jun 25, 2025
Class IIOngoingZ-1812-2025
Copan WASP recalls PhenoMATRIX
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology infor…
Copan WASPMay 28, 2025
Class IIOngoingZ-1696-2025
Spectrum Medical Ltd. recalls Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor
Medical device software marketed without FDA clearance .
Spectrum Medical Ltd.May 7, 2025
Class IIOngoingZ-1695-2025
Spectrum Medical Ltd. recalls Brand Name: Quantum Informatics - VIPER Product Name: Monitor
Medical device software marketed without FDA clearance .
Spectrum Medical Ltd.May 7, 2025
Class IIOngoingZ-1018-2025
Randox Laboratories, Limited recalls Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay…
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Randox Laboratories, L…Jan 29, 2025
Class IIOngoingZ-1017-2025
Randox Laboratories, Limited recalls Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay…
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Randox Laboratories, L…Jan 29, 2025