Medical DeviceJun 13, 2018
Hobbs Bronchial Cytology Brushes, Model Number 4202 recall — FDA Z-2052-2018
Device was marketed for uses outside the 510(k) clearance.
Class IIFDA: TerminatedHobbs Medical, Inc.
Latest records
Latest recalls — page 1419
The newest recall records with useful source details are listed here.
Medical DeviceJun 13, 2018
NordicNeuroLab AS fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows recall — FDA Z-2103-2018
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Class IIFDA: TerminatedNordicNeuroLab AS
Medical DeviceJun 13, 2018
SANTA JOY ORNAMENT & GIFTWARE CO Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations recall — FDA Z-1884-2018
It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products.
Class IIFDA: TerminatedSANTA JOY ORNAMENT & GIFTWARE CO
Medical DeviceJun 13, 2018
Invivo Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system recall — FDA Z-2115-2018
While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of…
Class IIFDA: OngoingInvivo Corporation
Medical DeviceJun 13, 2018
Orthofix Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2129-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker recall — FDA Z-2070-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Becton Dickinson & Company BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml recall — FDA Z-2056-2018
Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceJun 13, 2018
Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor recall — FDA Z-2047-2018
Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
Class IFDA: TerminatedDraeger Medical Systems, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker recall — FDA Z-2071-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
CareFusion 303 Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to recall — FDA Z-2111-2018
Reports of incorrect priming volume due to manufacturing with incorrect tubing.
Class IIFDA: TerminatedCareFusion 303, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Prog II recall — FDA Z-2091-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker recall — FDA Z-2066-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid recall — FDA Z-2079-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker recall — FDA Z-2067-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump recall — FDA Z-2112-2018
The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a…
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceJun 13, 2018
Stryker 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box recall — FDA Z-2057-2018
Inadvertent shipment of expired units.
Class IIFDA: CompletedStryker Corporation
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone recall — FDA Z-2086-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK IGE II recall — FDA Z-2097-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Orthofix Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only recall — FDA Z-2117-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone recall — FDA Z-2083-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia recall — FDA Z-2096-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK CA 19-9 recall — FDA Z-2069-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Fresenius Medical Care Renal Therapies Group NaturaLyte Liquid Acid Concentrate for recall — FDA Z-2110-2018
The bottles are mislabeled with an incorrect part number.
Class IIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Prolactin recall — FDA Z-2087-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026244 records · 4 categoriesSeptember 2026363 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories