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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36976–37000 of 40449

  • ModerateFDA (Devices)·Z-0474-2014·2013-12-18

    Synthes Trochanteric Fixation Nail Recalled for Incorrect Packaging Labeling

    Synthes USA is recalling 12 Trochanteric Fixation Nails because the packaging incorrectly lists the nail's length and diameter.

    Product
    Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0475-2014·2013-12-18

    Zimmer Trabecular Metal Total Ankle Talar Component Recall for Residue

    Zimmer, Inc. is recalling specific Total Ankle Talar Components because routine monitoring found potential elevated levels of manufacturing residue on the implants.

    Product
    Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0473-2014·2013-12-18

    Synthes TomoFix Osteotomy System Recalled for Surgical Technique Guide Labeling Error

    Synthes USA HQ, Inc. is recalling the TomoFix Osteotomy System due to a labeling error in the Surgical Technique Guide that may cause surgical delays.

    Product
    Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0483-2014·2013-12-18

    Stryker Recalls Cancellous Bone Screws Due to Packaging Error

    Stryker is recalling specific Cancellous Bone Screws because a 5.5 mm screw was found in packaging labeled for a 6.5 mm screw.

    Product
    Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0481-2014·2013-12-18

    Ultradent Recalls Avex CX2 Ceramic Orthodontic Brackets Due to Design Control Issues

    Ultradent is recalling 217 units of Avex CX2 Ceramic Orthodontic Brackets because the design control process was not completed before distribution.

    Product
    Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0438-2014·2013-12-11

    Siemens ARTISTE Linear Accelerator Recall for Dark Current Radiation Risk

    Siemens is recalling 26 ARTISTE Linear Accelerator systems due to a potential dark current radiation risk during specific IMRT treatments.

    Product
    SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0437-2014·2013-12-11

    Siemens Oncor Linear Accelerators Recalled for Dark Current Radiation Risk

    Siemens is recalling three Oncor Linear Accelerator units due to a potential dark current radiation risk during specific IMRT treatments.

    Product
    SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0452-2014·2013-12-11

    Synthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend

    Synthes USA is recalling 17 units of the Titanium Trochanteric Fixation Nail (TFN) System because two lots are missing a required second bend in the nail.

    Product
    Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0451-2014·2013-12-11

    Abbott i-STAT PT/INR Cartridges Recalled for Potential INR Errors

    Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated INR results.

    Product
    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2014·2013-12-11

    Sunrise Zippie Voyage Stroller Recalled for Potential Seat Dislodgement

    Sunrise Medical is recalling Zippie Voyage strollers because a plastic latch may deform, allowing the seat to dislodge and causing the occupant to slide out.

    Product
    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 449 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2014·2013-12-11

    Synthes Zero-P VA Implant Recalled for Potential Screw Back-Out Risk

    Synthes USA is recalling specific Zero-P VA implants because a screw could back out if the blocking mechanism is not visually confirmed to cover the screw head.

    Product
    Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2014·2013-12-11

    Intuitive Surgical Recalls da Vinci Patient Side Manipulator Assemblies

    Intuitive Surgical is recalling 1,386 da Vinci Patient Side Manipulator assemblies due to friction that can cause instrument motion to stall and catch up.

    Product
    Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2014·2013-12-11

    GE Centricity Web Software Recalled for Patient Safety Concerns

    GE Healthcare is recalling Centricity Web software due to an issue with rejected images that may impact patient safety.

    Product
    The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0440-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 274 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2014·2013-12-11

    Siemens syngo Lab Data Manager Software Recall for Auto-verification Failures

    Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager software versions VA11B and VA12A because the system may release results that require manual review or delay result transmission.

    Product
    syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2014·2013-12-11

    Olympus Recalls Thunderbeat Surgical Instruments Due to Component Damage

    Olympus America Inc. is recalling Thunderbeat surgical instruments because they may crack, break, or deform during use.

    Product
    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0431-2014·2013-12-11

    Philips Easy Diagnost Eleva Fluoroscopic Software Recall

    Philips Medical Systems is recalling 19 Easy Diagnost Eleva devices because they were delivered with outdated application software.

    Product
    Easy Diagnost Eleva Universal Fluoroscopic applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0444-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 16 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0446-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 80 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0449-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 8 units of Genesis II mobile bearing articular inserts because the Tyvek lid may not be adequately sealed.

    Product
    GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0447-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Sealing Defect

    Smith & Nephew is recalling 32 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0435-2014·2013-12-11

    CareFusion Recalls VersaSafe Extension Sets Due to Adhesive Defect

    CareFusion is recalling VersaSafe Extension Sets because excessive adhesive may prevent the male spin collar from operating as intended.

    Product
    VersaSafe Extension Set, Model No. 21000M-007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0439-2014·2013-12-11

    Varian Medical Systems Recalls C-Series Linear Accelerators for Software Correction

    Varian Medical Systems is recalling 3,809 C-Series linear accelerators to install a software solution that corrects a previous issue.

    Product
    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic…
    Category
    Medical Device
    Distribution
    Distributed nationwide