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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16501–16525 of 39988

  • HighFDA (Devices)·Z-2712-2020·2020-08-05

    TTDEYE Radial Brown Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Radial Brown colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2707-2020·2020-08-05

    Medtronic StealthStation S7 System Recalled for Navigation Inaccuracy

    Medtronic is recalling two StealthStation S7 Systems with Polaris Spectra Cameras due to a manufacturing issue that may cause 6mm navigation inaccuracy when using specific trackers.

    Product
    StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2730-2020·2020-08-05

    Teleflex Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical Inc is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The devices are used for tracheal intubation.

    Product
    Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2714-2020·2020-08-05

    TTDEYE Devil Red Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd. is recalling TTDEYE Devil Red colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2020·2020-08-05

    Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical Inc. is recalling 7,401 Rusch Greenlite laryngoscopes because the welded joint may break during use.

    Product
    Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2020·2020-08-05

    Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage

    Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joints may break. The devices are used for tracheal intubation.

    Product
    Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2020·2020-08-05

    Medline Recalls ClearPro T-Piece Closed Suction Catheters Due to Assembly Failure

    Medline Industries is recalling 2,440 units of ClearPro T-Piece Closed Suction Catheters because reports indicate the catheter may come apart from the device assembly during use.

    Product
    ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2704-2020·2020-08-05

    United Imaging uCT 530 CT System Recalled for Sharp Metal Edge

    Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-ray Systems because uneven metal edge overlap may create a sharp edge.

    Product
    Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2020·2020-08-05

    Teleflex Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical Inc is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 27,341 units distributed nationwide.

    Product
    Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2715-2020·2020-08-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 proton therapy systems because aborted irradiations cannot be resumed due to a software loading issue.

    Product
    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2705-2020·2020-08-05

    United Imaging uCT 550 CT Systems Recalled for Sharp Metal Edges

    Shanghai United Imaging Healthcare is recalling three uCT 550 Computed Tomography X-ray Systems because uneven metal edges on the mylar strip may create sharp edges.

    Product
    Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2701-2020·2020-08-05

    Abbott Alinity ci System Control Module Recalled for Quality Control Failures

    Abbott is recalling Alinity ci System Control Modules because quality control results were not properly evaluated for failures.

    Product
    Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2703-2020·2020-08-05

    United Imaging uCT 760 CT Systems Recalled for Sharp Metal Edges

    Shanghai United Imaging Healthcare is recalling five uCT 760 CT systems because uneven metal edges on the mylar strip may create sharp edges.

    Product
    Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2733-2020·2020-08-05

    Arthrex Recalls Sterile Low Profile Titanium Bone Screws Due to Length Error

    Arthrex, Inc. is recalling 28 units of sterile low profile titanium bone screws because the screws are 5mm shorter than intended.

    Product
    Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2713-2020·2020-08-05

    TTDEYE Radial Pink Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Radial Pink colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2732-2020·2020-08-05

    Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical Inc. is recalling 29,740 Rusch Greenlite laryngoscopes because the welded joint may break. The devices are used for tracheal intubation.

    Product
    Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2710-2020·2020-08-05

    TTDEYE Flower Brown Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Flower Brown colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2709-2020·2020-08-05

    TTDEYE Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Diamonds Starlight colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2711-2020·2020-08-05

    TTDEYE Flower Grey Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Flower Grey colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2739-2020·2020-08-05

    Synthes Recalls MatrixMIDFACE Screws Due to Incorrect Size Marking

    Synthes Produktions GmbH is recalling 41 units of MatrixMIDFACE Screws because the body clip was etched with the wrong size number.

    Product
    MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2700-2020·2020-08-05

    Steris InnoWave Sonic Irrigator Recalled for Unclear Installation Test Criteria

    Steris Corporation is recalling 1,283 InnoWave Sonic Irrigators because an FDA inspection found that the foil test performed during installation lacks clear acceptance criteria.

    Product
    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2020·2020-08-05

    Resource Optimization Recalls Regard Migrating Indicator Strips for Malfunction

    Resource Optimization & Innovation LLC is recalling Regard Migrating Indicator Strips because they malfunction and fail to reach the accept window during use.

    Product
    regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2020·2020-08-05

    Smith & Nephew T-F1X0 RCG Drill Pac Recalled for Missing Sleeve

    Smith & Nephew is recalling T-F1X0 RCG Drill Pacs because some sterile packages contain only one sleeve instead of two, preventing the device from performing as intended for the second bone tunnel.

    Product
    Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2698-2020·2020-08-05

    Synthes Recalls MatrixNEURO Screws Due to Incorrect Body Clip Labeling

    Synthes, Inc. is recalling 104 units of MatrixNEURO 5mm screws because the body clip is etched with '4', incorrectly indicating a 4mm screw, despite correct outer packaging.

    Product
    MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2706-2020·2020-08-05

    Richard Wolf Recalls Tube Set for Transanal Endoscopic Microsurgery

    Richard Wolf GmbH is recalling 338 Tube Sets for TEM because smaller diameter tube material was used. The affected units were distributed internationally.

    Product
    Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope…
    Category
    Medical Device
    Distribution
    0 states