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.

14226–14250 of 21645

  • ModerateFDA (Devices)·Z-2317-2016·2016-08-10

    Medtronic Navigation Recalls Fusion ENT Software Application

    Medtronic Navigation is voluntarily recalling 27 units of the Fusion ENT software application due to a field action involving Neurologica scanners.

    Product
    Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2016·2016-08-10

    Zimmer Biomet Recalls V-Tek Twist Drills Due to Tolerance Issues

    Zimmer Biomet is voluntarily recalling 169 V-Tek Twist Drills because a potential tolerance stack-up was identified between the drill and the mating Kirschner Wire component.

    Product
    V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2302-2016·2016-08-10

    Ortho-Clinical Diagnostics Recalls VITROS Total T4 Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Total T4 Reagent Packs because test results may show a negative bias before the 8-week storage limit.

    Product
    VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2016·2016-08-10

    Implant Direct Recalls RePlant Angled Abutments Due to Design Defect

    Implant Direct Sybron Manufacturing is recalling 205 RePlant Angled Abutments because they are oversized due to a design specification issue.

    Product
    RePlant¿ Angled Abutment Part Number 6050-52-60
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2318-2016·2016-08-10

    Medtronic Navigation Recalls StealthStation Software Applications

    Medtronic Navigation is voluntarily recalling StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2340-2016·2016-08-10

    Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 110 units of the Air Dermatome II Width Plate because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2301-2016·2016-08-10

    Merge PACS software recall for missing patient data in telmed studies

    Merge Healthcare is recalling specific versions of Merge PACS software because studies received via telmed were missing patient DOB, procedure, and referring physician information.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2322-2016·2016-08-10

    Zimmer Biomet Recalls Twist Drills Due to Tolerance Issues

    Zimmer Biomet is voluntarily recalling 169 Twist Drills and V-Tek Twist Drills because of a potential tolerance stack-up issue with Kirschner Wire components.

    Product
    TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2314-2016·2016-08-10

    Medtronic Navigation Recalls StealthStation Software Applications

    Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2016·2016-08-10

    Medtronic Navigation Recalls S7 MACH FrameLink Software Applications

    Medtronic Navigation is conducting a voluntary field action for S7 MACH FrameLink software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2016·2016-08-10

    Beckman Coulter AU680 Chemistry Analyzers Recalled for Leaking C Cups

    Beckman Coulter is recalling AU680 Chemistry Analyzers because leaking and cracked C cups can cause coolant to leak onto circuit boards, resulting in short-circuits and instrument stop mode.

    Product
    AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2264-2016·2016-08-03

    Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues

    The Metrix Company is recalling 250 mL and 500 mL container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications when dispensing into bags.

    Product
    Container fill and transfer sets, 250 mL and 500 mL, . .
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2283-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 256 units of Anastoclip AC Clips because marketing materials incorrectly stated they could be used for dura closure.

    Product
    Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1450-2016·2016-08-03

    Sagent Pharmaceuticals Recalls Oxacillin for Injection Due to Particulate Matter

    Sagent Pharmaceuticals is recalling Oxacillin for Injection due to the presence of small, dark particulate matter in the solution after reconstitution.

    Product
    Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2279-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling Video Processor EPK-i5010 units because they were shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2262-2016·2016-08-03

    Metrix Dual Chamber Container Fill and Transfer Sets Recalled for Accuracy Issues

    The Metrix Company is recalling Dual Chamber Container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications for dispensing volume.

    Product
    Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2287-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 39 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2297-2016·2016-08-03

    Smith & Nephew Recalls Spherical Head Reflection Cancellous Screws Due to Labeling Error

    Smith & Nephew is recalling 185 units of Spherical Head Reflection 6.5 mm Cancellous Screws because the packaging contained 35mm screws instead of the labeled 25mm size.

    Product
    SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2299-2016·2016-08-03

    Siemens Recalls Theophylline Reagent Due to Increased Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Theophylline reagents because they may exhibit increased imprecision when used with certain quality control materials.

    Product
    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2298-2016·2016-08-03

    Siemens Syva EMIT 2000 Theophylline Reagent Recall for Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Syva EMIT 2000 Theophylline reagents due to potential increased imprecision when used with certain quality control materials.

    Product
    Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2251-2016·2016-08-03

    Best Theratronics Cabinet X-Ray Systems Recalled for Performance Non-Compliance

    Best Theratronics is recalling 128 cabinet x-ray systems used to irradiate blood products because they failed to comply with performance standards.

    Product
    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2284-2016·2016-08-03

    LeMaitre Vascular Recalls AnastoClip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 471 units of AnastoClip AC Clips because marketing materials incorrectly suggested they could be used for dura closure.

    Product
    AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2280-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.

    Product
    Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2289-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 20 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, while it is only intended for cardiovascular use.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide