The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

6776–6800 of 21595

  • ModerateFDA (Devices)·Z-2281-2020·2020-06-17

    Siemens Atellica CH Fructosamine Reagent Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine Reagent because acetaminophen metabolites may interfere with test results.

    Product
    Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding tw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2020·2020-06-17

    Biomet Recalls A.L.P.S. Proximal Humerus Plating System for Design Documentation Issues

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System plates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2316-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files

    Biomet is recalling 16 units of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2359-2020·2020-06-17

    Physio-Control Recalls Infant Defibrillation Electrodes Due to Packaging Seal Issues

    Physio-Control is recalling infant and child defibrillation electrodes because the packaging was not properly sealed. The recall affects units manufactured between August 2017 and October 2019.

    Product
    Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2304-2020·2020-06-17

    Biomet 8.0 Cannulated Screw Tap Recalled for Incomplete Design History Files

    Biomet is recalling 8.0 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.

    Product
    Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History

    Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files

    Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because units were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2286-2020·2020-06-17

    Ormco Damon Q2 Orthodontic Bracket Recalled for Packaging Labeling Error

    Ormco/Sybronendo is recalling 2,189 units of Damon Q2 Orthodontic Metal Brackets because the bracket torque was mislabeled on the packaging.

    Product
    Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has bee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2293-2020·2020-06-17

    Eizo RadiForce GX560 Monochrome LCD Monitor Recalled for Display Defect

    Eizo Corporation is recalling 96 RadiForce GX560 monochrome LCD monitors because a marble pattern may infrequently appear on the screen under certain conditions.

    Product
    RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practiti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2020·2020-06-17

    Physio-Control Recalls Infant Child Starter Kits Due to Packaging Seal Issues

    Physio-Control is recalling 6,732 Infant Child Starter Kits because the packaging for the reduced energy electrodes was not properly sealed.

    Product
    Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2357-2020·2020-06-17

    BD FACS Sample Prep Assistant II Upgrade Recalled for Probe Wear

    Becton, Dickinson and Company is recalling 51 units of the BD FACS Sample Prep Assistant II Upgrade due to premature probe wear that may cause sample dispensing issues.

    Product
    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2358-2020·2020-06-17

    BD FACS Sample Prep Assistant III Recalled for Probe Wear Issues

    Becton, Dickinson and Company is recalling 467 units of the BD FACS Sample Prep Assistant III because probes may wear prematurely, causing sample dispensing failures.

    Product
    BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Locking Pegs Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Locking Pegs 60mm because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2308-2020·2020-06-17

    Biomet A.L.P.S. Cortical Screw Recalled for Incomplete Design History

    Biomet is recalling A.L.P.S. T15 Low Profile Cortical Screws because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2356-2020·2020-06-17

    BD FACS Sample Prep Assistant II Recalled for Probe Wear Issues

    Becton, Dickinson and Company is recalling 95 units of the BD FACS Sample Prep Assistant II because probes may wear prematurely, causing sample dispensing failures.

    Product
    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphoc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2287-2020·2020-06-17

    Alcon Recalls AcrySof IQ Intraocular Lenses Due to Incorrect Diopter

    Alcon Research LLC is recalling 84 units of AcrySof IQ intraocular lenses because they have an incorrect diopter. The lenses were distributed nationwide.

    Product
    Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2290-2020·2020-06-17

    Qiagen Recalls EGFR PCR Kits Due to False Positive Risk

    Qiagen is recalling 530 therascreen EGFR RGQ PCR Kits because a fluorescence artifact can cause rare false mutation positive results.

    Product
    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2317-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Design History Deficiencies

    Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because it was distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2306-2020·2020-06-17

    Biomet A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeve Recalled

    Biomet is recalling A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Drill Bit Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Calibrated Drill Bits because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2301-2020·2020-06-17

    Immuno-Mycologics Recalls Histoplasma ID Antigen Due to Contamination

    Immuno-Mycologics is recalling 155 vials of Histoplasma ID Antigen because potential reagent contamination may cause false positive test results.

    Product
    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
    Category
    Medical Device
    Distribution
    Distributed nationwide