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.

16801–16825 of 21645

  • ModerateFDA (Devices)·Z-1143-2015·2015-03-04

    Angiodynamics Recalls Starburst MRI Electrode Devices Due to Marking Error

    Angiodynamics is recalling 43 Starburst MRI Semi-Flex Electrode Devices because a printed distance mark is incorrectly located 4cm from the tip instead of 5cm.

    Product
    Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1147-2015·2015-03-04

    Medtronic Neurostimulator Recall Due to Inaccurate Battery Longevity Estimates

    Medtronic is recalling specific neurostimulator models because enabling cycling at certain settings may decrease battery life and cause inaccurate longevity estimates on the programmer.

    Product
    The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1142-2015·2015-03-04

    Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference

    Intuitive Surgical is recalling EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.

    Product
    EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1124-2015·2015-02-25

    Teleflex Recalls RUSCH Endotracheal Tubes for Cuff Diameter Labeling Error

    Teleflex is recalling RUSCH Curved Reinforced Endotracheal Tubes because the labeled cuff diameter does not match the actual cuff diameter, though the actual product meets specifications.

    Product
    R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1117-2015·2015-02-25

    Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use

    Intuitive Surgical is recalling Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.

    Product
    HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0387-2015·2015-02-25

    Hospira Recalls Vancomycin Hydrochloride Injection Due to Temperature Abuse

    Hospira Inc. is recalling specific lots of Vancomycin Hydrochloride for Injection because they experienced uncontrolled temperature excursions during transit.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1129-2015·2015-02-25

    Cincinnati Sub-Zero CT-99 Cold Therapy Pad Recall for Seal Separation

    Cincinnati Sub-Zero is recalling CT-99 cold therapy pads because seals may separate during use, causing water leaks.

    Product
    Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2015·2015-02-25

    Biomet Recalls Specific Lot of Mallory Head Acetabular Shell Components

    Biomet is recalling 17 units of the Mallory Head 4 Finned Acetabular Shell 50 mm (Lot 364600) due to a packaging mix-up with a different shell size.

    Product
    Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1121-2015·2015-02-25

    Pulsiocath PiCCO ProAQT Monitoring Kit Recalled for Packaging Defects

    Pulsion Medical Inc is recalling 90 units of the Pulsiocath PiCCO ProAQT Monitoring Kit due to cracks and holes found in the primary packaging.

    Product
    Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0388-2015·2015-02-25

    Hospira Recalls Ketorolac Tromethamine Injections Due to Temperature Abuse

    Hospira Inc. is recalling 100 vials of Ketorolac Tromethamine Injection due to uncontrolled temperature excursions during transit. The product was limited to one shipment to a distributor.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2015·2015-02-25

    Siemens Artis One Angiography System Recalled for Monitor Failure

    Siemens Medical Solutions is recalling one Artis One angiography system because the monitor may fail and require a power cycle to resume operation.

    Product
    Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1123-2015·2015-02-25

    Biomet Recalls Acetabular Shell Components Due to Packaging Mix-Up

    Biomet is recalling specific acetabular shell components for hip prostheses due to a packaging mix-up between two different product lots.

    Product
    Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1118-2015·2015-02-25

    Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use

    Intuitive Surgical is recalling 12,467 Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.

    Product
    HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0390-2015·2015-02-25

    Hospira Recalls Vancomycin Hydrochloride Injection Due to Temperature Excursions

    Hospira Inc. is recalling 90,600 vials of Vancomycin Hydrochloride for Injection because the products experienced uncontrolled temperature excursions during transit.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1130-2015·2015-02-25

    Haemonetics TEG Hemostasis System Level II Control Recall

    Haemonetics is recalling specific lots of TEG Hemostasis System Level II Control kits because they produce high Maximum Amplitude results outside the expected quality control range.

    Product
    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1110-2015·2015-02-18

    Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues

    Arthrosurface, Inc. is recalling 136 units of HemiCAP shoulder prosthetic components because they were not cleared for marketing in the US with current indications.

    Product
    Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1066-2015·2015-02-18

    Stryker Recalls System 6 Aseptic Housings Due to Weld Defect

    Stryker is recalling 399 System 6 Aseptic Housings because a failed test revealed a lack of a continual weld. Customers are instructed to return the product to Stryker.

    Product
    System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1078-2015·2015-02-18

    Teleflex Recalls Preformed Tracheal Tubes Due to Incorrect Labeling

    Teleflex Medical is recalling 300 units of preformed tracheal tubes because they are incorrectly labeled as cuffed oral tubes instead of uncuffed nasal tubes.

    Product
    Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1093-2015·2015-02-18

    Stryker Recalls MEDPOR Titan Max Orbital Floor and Wall Implants

    Stryker is recalling MEDPOR Titan Max Orbital Floor and Wall implants due to incorrect barrier location and potential mix-ups with left-sided units.

    Product
    MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2015·2015-02-18

    TeraRecon Recalls Aquarius iNtuition Client Viewer Software Due to Anomaly

    TeraRecon is recalling 91 units of the Aquarius iNtuition Client Viewer due to a software anomaly in the RECIST 1.1 evaluation criteria.

    Product
    Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1095-2015·2015-02-18

    Teleflex Recalls Hudson RCI Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling specific Hudson RCI Humidifier Adaptors because the packages may contain black particles. The recall affects units distributed worldwide.

    Product
    Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1108-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1202-2015·2015-02-18

    HVL Recalls Melatonin Tablets Containing Digestive Enzyme Supplement

    HVL, LLC is recalling 278 bottles of Melatonin Control-Released Tablets that contained a vegetarian digestive enzyme instead of melatonin.

    Product
    Melatonin Control- Released Tablets, 60 tablets, in plastic bottles, Manufactured by Douglas Laboratories, Pittsburgh, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1105-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain foreign material, specifically black particles.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2015·2015-02-18

    Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error

    Natus Medical is recalling EPWorks software versions prior to 6.0 used in the Xltek Protektor Stimulator. A software error prevents remote users from stopping free run waveform groups.

    Product
    EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
    Category
    Medical Device
    Distribution
    Distributed nationwide