The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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29476–29500 of 40325

  • HighFDA (Devices)·Z-2321-2016·2016-08-10

    Zimmer Biomet Recalls Twist Drills Due to Tolerance Stack Up

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

    Product
    TWIST DR 25X95MM Cann 12MM Thd 30MM 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
  • HighFDA (Devices)·Z-2332-2016·2016-08-10

    Stryker Recalls Spirit Select and Plus Hospital Beds Due to Actuator Failure

    Stryker Medical is voluntarily recalling Spirit Select and Spirit Plus hospital beds because broken actuators may cause the bed to lower unexpectedly, risking patient injury.

    Product
    Spirit Select Bed, A-C Powered Hospital Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2308-2016·2016-08-10

    Beckman Coulter Recalls AU480 Chemistry Analyzers Due to Leaking C Cups

    Beckman Coulter is recalling AU480 Chemistry Analyzers because leaking C cups can cause coolant to short-circuit the instrument's circuit boards.

    Product
    AU480 Chemistry Analyzers, Reference No. B28624 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-2310-2016·2016-08-10

    Beckman Coulter AU5800 Chemistry Analyzers Recalled for Leaking C Cups

    Beckman Coulter is recalling AU5800 Chemistry Analyzers because cracked C cups can leak coolant onto circuit boards, causing short-circuits and instrument stop mode.

    Product
    AU5800 Chemistry Analyzers, Reference No. A98352 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-2337-2016·2016-08-10

    Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 90 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, 2 inch. Part # 885120200. 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-2330-2016·2016-08-10

    Dako EnVision FLEX+ Mouse High pH Kits Recalled for pH Error

    Dako Denmark A/S is recalling 147 kits of EnVision FLEX+ Mouse, High pH (Link) because the Target Retrieval Solution has an incorrect pH level.

    Product
    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2303-2016·2016-08-10

    Merge PACS Software Recall for Annotation Display Defect

    Merge Healthcare is recalling Merge PACS 6.0 software because it fails to display annotations on certain loaded studies.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2325-2016·2016-08-10

    BK Medical bk3500 Ultrasound Scanner Recalled for Volume Calculation Error

    B-K Medical A/S is recalling six bk3500 ultrasound systems because the generic volume measurement function may display incorrect calculations, potentially affecting diagnostic accuracy.

    Product
    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2336-2016·2016-08-10

    Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 70 units of Air Dermatome II Width Plates because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2335-2016·2016-08-10

    Zimmer Air Dermatome II Handpiece Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 220 Air Dermatome II handpieces because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2016·2016-08-10

    Medtronic StealthStation Software Recalled Due to Scanner Compatibility Issues

    Medtronic Navigation is voluntarily recalling 27 units of StealthStation software due to compatibility issues with specific floor-based scanners.

    Product
    MACH AxiEM 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2016·2016-08-10

    Medtronic Navigation Recalls Synergy Cranial S7 Software Applications

    Medtronic Navigation is conducting a voluntary field action for Synergy Cranial S7 software applications due to compatibility issues with specific floor-based scanners.

    Product
    Synergy Cranial S7. 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-2304-2016·2016-08-10

    Roche Recalls Vancomycin Assay Kits Due to Incorrect Method Sheets

    Roche Diagnostics is voluntarily recalling Vancomycin assay kits because method sheets contain incorrect comparison data for specific analyzers.

    Product
    ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2316-2016·2016-08-10

    Medtronic Navigation StealthStation Software Voluntary Field Action

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

    Product
    Synergy Spine. 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-2338-2016·2016-08-10

    Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 60 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, 1.5 inch. Part #00-8851-215-00. 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2326-2016·2016-08-10

    Mentor MemoryGel Breast Implant Recall Due to Missing Date Labels

    Mentor Texas, LP is recalling 35 units of 300cc MemoryGel Breast Implants because the boxes were labeled with null manufacturing and expiration dates.

    Product
    Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2329-2016·2016-08-10

    AccessClosure Recalls MynxGrip Vascular Closure Devices Due to Packaging Errors

    AccessClosure is recalling 70 MynxGrip Vascular Closure Devices shipped with improper transport and packaging configurations.

    Product
    6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2334-2016·2016-08-10

    Zimmer Air Dermatome II Handpieces Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 630 Air Dermatome II handpieces because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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