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.

16826–16850 of 21645

  • ModerateFDA (Devices)·Z-1112-2015·2015-02-18

    Arthrosurface Shoulder Prosthesis Components Recalled for Uncleared Marketing Status

    Arthrosurface, Inc. is recalling 138 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.

    Product
    Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1113-2015·2015-02-18

    Arthrosurface Recalls Uncleared Taper Post Fixation Components

    Arthrosurface, Inc. is recalling 182 units of Athrosurface Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.

    Product
    Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2015·2015-02-18

    Sun Pharma Recalls Levetiracetam Extended Release Tablets for Dissolution Failure

    Sun Pharma Global Fze is recalling 3,263 bottles of Levetiracetam extended release tablets because they failed to meet dissolution specifications at the 6-month time point.

    Product
    Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2015·2015-02-18

    Biomet Spine Recalls Timberline Cranial Caudal and Posterior Blades

    Biomet Spine, LLC is recalling Timberline Cranial Caudal and Posterior Blades due to an oversize set screw hex feature.

    Product
    Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1085-2015·2015-02-18

    Teleflex Recalls LMA Supreme Size 5 Due to Potential Size 4 Mislabeling

    Teleflex Medical is recalling 2,640 units of LMA Supreme (New Cuff) Size 5 devices because some may be mislabeled as Size 5 but are actually Size 4.

    Product
    LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2015·2015-02-18

    Arthrosurface Shoulder Prosthesis Components Recalled for Lack of US Clearance

    Arthrosurface, Inc. is recalling 187 units of the HHXL (OVO) 15.6x32mm Taper Post Fixation Component because the product was not cleared for marketing in the US with its current indications.

    Product
    Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2015·2015-02-18

    Zimmer Dental Recalls GemLock Long Hex Driver Due to Fit Issues

    Zimmer Dental Inc is recalling 627 GemLock Long Hex Drivers because they may not fit into the Fixture Mount Transfer or the implant's internal hex.

    Product
    GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1067-2015·2015-02-18

    Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error

    Natus Medical is recalling EPWorks software versions prior to 6.0 because a software error prevents remote users from stopping free run waveform groups.

    Product
    EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1056-2015·2015-02-11

    Siemens ACUSON SC2000 Ultrasound System Control Panel Bolt Recall

    Siemens is recalling 230 ACUSON SC2000 ultrasound systems because a bolt holding the control panel may fail, preventing the panel from locking into position.

    Product
    ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1058-2015·2015-02-11

    Puritan Bennett 980 Ventilator Recalled for Occasional GUI Resets

    Covidien is voluntarily recalling 418 Puritan Bennett 980 ventilators due to occasional graphical user interface resets lasting approximately 30 seconds.

    Product
    Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0383-2015·2015-02-11

    Taro Recalls Children's Loratadine Syrup Due to Blue Plastic Presence

    Taro Pharmaceuticals is recalling 36,684 bottles of Children's Loratadine Syrup because blue plastic was found floating in the liquid.

    Product
    Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1048-2015·2015-02-11

    Intuitive Surgical Recalls da Vinci Si Wall Charts for Sterilization Inconsistency

    Intuitive Surgical is recalling 1,034 da Vinci Si Wall Charts because they contained incorrect sterilization dry time information inconsistent with the User Manual.

    Product
    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1057-2015·2015-02-11

    Medtronic Recalls KYPHON EXPRESS Osteo Introducer System Due to Labeling Error

    Medtronic is recalling 239 units of the KYPHON EXPRESS Osteo Introducer System because the packaging may contain the wrong instrument tips.

    Product
    KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1047-2015·2015-02-11

    Fresenius Crit Line in a Clip Monitor Recalled for Display Misinterpretation

    Fresenius Medical Care is recalling 35 Crit Line in a Clip monitors due to a potential for misinterpretation of the Blood Volume slope graphic display.

    Product
    Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1018-2015·2015-02-11

    FDA Recalls Covidien Trellis-8 Peripheral Infusion Systems Due to Labeling Error

    FDA is recalling 1,032 units of the Covidien Trellis-8 Peripheral Infusion System because a manufacturing error caused the proximal and distal balloon inflation ports to be incorrectly labeled.

    Product
    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2015·2015-02-11

    Hospira Recalls Plum A+ Infusion Systems with Cracked Pole Clamp Assemblies

    Hospira Inc. is recalling 102 Plum A+ Infusion Systems because cracked pole clamp assemblies prevent the devices from securely attaching to IV poles.

    Product
    Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1043-2015·2015-02-11

    Stryker Recalls Trident PSL Hip Shells Missing Dome Hole Plugs

    Stryker Howmedica Osteonics is recalling seven units of Trident PSL HA Solid Back 50 mm hip shells because the dome hole plugs were missing from the packages.

    Product
    Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0942-2015·2015-02-11

    Gemini Foods Recalls Dried Bean Curd Due to Dimethyl Yellow Contamination

    Gemini Foods is recalling dried bean curd products because they may be contaminated with dimethyl yellow. The recall covers 3,360 units distributed nationwide.

    Product
    Dried Bean Curd Anka Flavor 24x150g, Item No. 8535
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1033-2015·2015-02-11

    Express Diagnostics Recalls DrugCheck Ketamine Dip Tests for False Positives

    Express Diagnostics is recalling DrugCheck Ketamine Dip Tests because they may produce false positive results, leading to incorrect screening outcomes.

    Product
    DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1037-2015·2015-02-11

    FDA Recalls 16cm Minimally Invasive Attachment Due to Incorrect Color Bands

    The Anspach Effort, Inc. is recalling 8 units of the MIA16-G1 Minimally Invasive Attachment because customer complaints indicated the color bands were not correct.

    Product
    16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1023-2015·2015-02-04

    Beckman Coulter Lipase Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Lipase Assay kits because N-acetyl cysteine can cause falsely low results.

    Product
    Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1012-2015·2015-02-04

    Aesculap Miethke Shunt System Accessories Recalled for Incorrect MR Safety Labeling

    Aesculap, Inc. is recalling Miethke Shunt System accessories because the shelf box labels incorrectly display an MR conditional symbol. The product is actually MR unsafe, and the correct information is only provided in the Instructions for Use.

    Product
    Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    Distributed nationwide