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.

16376–16400 of 21645

  • ModerateFDA (Devices)·Z-1662-2015·2015-06-03

    Siemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Water Feed Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1667-2015·2015-06-03

    Siemens Ysio Max Radiographic System Recalled for Software Data Loss

    Siemens is recalling 133 Ysio Max radiographic systems because a software defect can delete acquired images and studies, requiring patients to repeat exposures.

    Product
    SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1666-2015·2015-06-03

    United Surgical Associates Recalls Keo Wrist Braces for Missing Latex Label

    United Surgical Associates is recalling 756 Keo elastic wrist braces because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.

    Product
    Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1670-2015·2015-06-03

    Siemens Uroskop Omnia Max X-Ray System Software Data Loss Recall

    Siemens is recalling 133 Uroskop Omnia Max X-ray systems due to software defects that cause image deletion and connection issues.

    Product
    SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1109-2015·2015-06-03

    Blenheim Pharmacal Recalls Captopril Tablets Due to cGMP Deviations

    Blenheim Pharmacal is recalling 166 bottles of Captopril 50 mg tablets distributed in Indiana due to cGMP deviations and inadequate complaint investigations.

    Product
    Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1110-2015·2015-06-03

    Blenheim Pharmacal Recalls Clarithromycin Tablets Due to cGMP Deviations

    Blenheim Pharmacal is recalling 50 bottles of Clarithromycin Tablets 500 mg in Indiana due to cGMP deviations and inadequate complaint investigation.

    Product
    Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1646-2015·2015-06-03

    Siemens SOMATOM Perspective CT Scanner Software Recall

    Siemens is recalling 75 SOMATOM Perspective CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1664-2015·2015-06-03

    United Surgical Associates Recalls Elastic Ankle Supports for Missing Latex Label

    United Surgical Associates is recalling 1,278 Elastic Ankle Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.

    Product
    Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1682-2015·2015-06-03

    Philips Ingenuity TF PET/MRI Recalled for Incorrect Chemical Shift Imaging Data

    Philips Medical Systems is recalling 10 Ingenuity TF PET/MRI systems because the spectroscopy voxel map did not align with anatomical images, resulting in incorrect orientation of Chemical Shift Imaging data.

    Product
    Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1620-2015·2015-05-27

    Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speaker malfunctions.

    Product
    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1634-2015·2015-05-27

    Stryker Scorpio femoral component recall due to blister seal strength

    Stryker Howmedica Osteonics is recalling 1,147 Scorpio femoral components because the inner blister peel strength may be below validated requirements, potentially affecting sterile barrier shelf life.

    Product
    Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1632-2015·2015-05-27

    Philips EPIQ 7 Ultrasound System Recalled for Unit Conversion Error

    Philips is recalling EPIQ 7 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1)…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1635-2015·2015-05-27

    Stryker Triathlon Femoral Component Recalled for Sterile Barrier Seal Issues

    Stryker Howmedica Osteonics is recalling 1,147 Triathlon femoral components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

    Product
    Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2015·2015-05-27

    Stryker Howmedica Hip Prosthesis Components Recalled for Seal Defects

    Stryker Howmedica is recalling 1,147 RESTORATION Acetabular Augment System components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

    Product
    Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1621-2015·2015-05-27

    bioMerieux MYLA Server Software Recalled for Processing Failures

    bioMerieux is recalling MYLA V3 server software because it may stop processing data in high-volume settings, requiring remote or on-site service.

    Product
    MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1626-2015·2015-05-27

    Wright Medical Recalls Phalinx Hammertoe Handles Due to Incorrect Laser Etching

    Wright Medical Technology is recalling 124 units of Phalinx Hammertoe Handles because the term DORSAL was laser etched on the incorrect side.

    Product
    PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1636-2015·2015-05-27

    MelaFind Device Recalled for Unapproved User Interface Data Display

    MELA Sciences is recalling 65 MelaFind devices because the probability and histogram data displayed in the user interface lacks FDA approval.

    Product
    MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1627-2015·2015-05-27

    Wright Medical Recalls PHALINX Hammertoe Handles Due to Incorrect Laser Etching

    Wright Medical Technology is recalling 126 units of PHALINX Hammertoe Handles because the term 'DORSAL' was laser etched on the incorrect side.

    Product
    PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1554-2015·2015-05-27

    Philips DigitalDiagnost X-Ray System Recalled for Missing Exposure Beep Signal

    Philips Medical Systems is recalling 54 DigitalDiagnost X-Ray systems because they fail to emit a beep signal after exposure if powered on for over 12 hours.

    Product
    Philips Healthcare DigitalDiagnost System X-Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1618-2015·2015-05-27

    Integra Recalls Camino ICP Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP Monitors because the audible speaker may malfunction. The recall covers 1,482 units distributed worldwide.

    Product
    The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2301-2015·2015-05-27

    La Fe Green Hot Sauce Recalled for Undeclared Food Dyes

    Le Fe Foods, Inc. is recalling La Fe Green Hot Sauce because it contains undeclared FD & C Blue #1 and FD & C Yellow #5.

    Product
    La Fe Green Hot Sauce, 5.6 Fl. Oz. - 165 mL, Imported by: G & T Foods, Inc., Moonachie, N.J. 07074, Distributed by: LA FE Foods, Product of Columbia, UPC 023545211052
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1619-2015·2015-05-27

    Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speakers may malfunction.

    Product
    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1625-2015·2015-05-27

    Wright Medical Recalls Phalinx Hammertoe Handle Due to Incorrect Etching

    Wright Medical Technology is recalling 121 units of Phalinx Hammertoe Handles because the word 'DORSAL' was laser-etched on the incorrect side.

    Product
    PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1555-2015·2015-05-27

    Philips DuraDiagnost X-Ray System Recalled for Missing Exposure Beep

    Philips Medical Systems is recalling DuraDiagnost X-ray systems because they may fail to emit a termination beep after 12 hours of operation, violating safety regulations.

    Product
    Philips Healthcare DuraDiagnost X- Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide