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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29401–29425 of 40325

  • LowFDA (Devices)·Z-2471-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling 1,648,273 dental implant devices because pouches may not have been sealed during packing.

    Product
    Implant EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2538-2016·2016-08-24

    Telefax Medical Recalls Weck EFx Fascial Closure System for Labeling Error

    Teleflex Medical is recalling 45 units of the Weck EFx Classic Fascial Closure System because incorrect expiration dates were printed on the labels.

    Product
    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2453-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Pick-Up Coping (Hexed) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2511-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Certain EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2512-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutment dental implants because pouches may not have been sealed during packing.

    Product
    Certain Bellatek Encode Healing Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2580-2016·2016-08-24

    Ortho-Clinical Diagnostics Recalls VITROS TSH Reagent Packs Due to Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS TSH Reagent Packs because calibration curves frequently fall outside quality parameters, potentially delaying test results.

    Product
    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone…
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2523-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Post Dental Implants

    Biomet 3i is recalling certain Gingihue Post Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2016·2016-08-17

    Integra External Fixation System Wire Fixation Bolts Recalled for Breakage

    Integra LifeSciences Corp. is recalling Universal Wire Fixation Bolts because the Slotted Post broke during use at the surgical site.

    Product
    Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2402-2016·2016-08-17

    Invacare Bariatric Bed Junction Boxes Recalled for Fire Risk

    Invacare Corporation is recalling 1,011 Bariatric home care beds because the junction boxes may spark, posing a fire hazard in the presence of flammable materials.

    Product
    Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2342-2016·2016-08-17

    BioMerieux Recalls NucliSENS easyMAG Magnetic Silica Reagents

    BioMerieux is recalling NucliSENS easyMAG Magnetic Silica reagents due to customer complaints about amplification performance issues.

    Product
    NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2351-2016·2016-08-17

    Richard Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Contamination

    Richard-Allan Scientific Company is recalling 18 cases of 10% Neutral Buffered Formalin due to potential potassium hydroxide contamination that may affect immunohistochemistry test results.

    Product
    Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2401-2016·2016-08-17

    Invacare Bariatric Bed Foot Section Recalled for Fire Hazard

    Invacare Corporation is recalling 3,050 Bariatric Bed Foot Sections because a junction box defect may cause sparks and fire.

    Product
    Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2399-2016·2016-08-17

    Invacare Bariatric Bed Recalled for Junction Box Fire Risk

    Invacare is recalling 2,184 Bariatric Beds because a defect in the Junction Box may cause sparks, posing a fire hazard in the presence of flammable materials.

    Product
    Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2400-2016·2016-08-17

    Invacare Bariatric Bed Recalled for Potential Fire Hazard from Junction Box Sparks

    Invacare is recalling 2,702 Bariatric Beds because the junction box may spark, posing a fire risk in the presence of flammable materials.

    Product
    Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2387-2016·2016-08-17

    Integra External Fixation System Slotted Post Recall for Breakage During Use

    Integra LifeSciences is recalling 111 units of External Fixation System Slotted Posts because they broke during use at the surgical site.

    Product
    Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2388-2016·2016-08-17

    Edan Diagnostics Recalls EtCO2 Modules for Incorrect CO2 Readings

    Edan Diagnostics is recalling 521 EtCO2 modules used in patient monitors because they may provide incorrect CO2 readings.

    Product
    EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2016·2016-08-17

    Merge PACS software recalled due to patient name mismatch

    Merge Healthcare is recalling PACS software versions V6.0.2.0 MR2 and earlier because patient names in the interface do not match the displayed images.

    Product
    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2016·2016-08-17

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of 'Stapler Firing Failed' messages.

    Product
    STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2525-2016·2016-08-17

    Siemens Stratus CS STAT Fluorometric Analyzer Software Defect Recall

    Siemens is recalling Stratus CS STAT Fluorometric Analyzers due to a software defect that may cause inaccurate test results or out-of-range values when TestPaks are near expiration.

    Product
    Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2397-2016·2016-08-17

    Zimmer Biomet Recalls Zyston Transform Instrument Cases Due to Locking Defect

    Zimmer Biomet Spine, Inc. is voluntarily recalling Zyston Transform Instrument Cases and Implant Kits because the implant locking mechanism is not functioning as intended.

    Product
    Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2016·2016-08-17

    Teleflex Servo Humidifier 163 Recalled Due to Connector Cracks

    Teleflex Medical is recalling Servo Humidifier 163 units because cracks may occur at the ISO female connectors.

    Product
    Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2016·2016-08-17

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of firing failures.

    Product
    CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2348-2016·2016-08-17

    Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Firing Failures

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 devices due to an increased trend of stapler firing failures.

    Product
    STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection…
    Category
    Medical Device
    Distribution
    1 state