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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

19676–19700 of 27682

  • HighFDA (Devices)·Z-2088-2017·2017-05-24

    Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage Risk

    Aesculap Implant Systems LLC is recalling ELAN 4 2-Ring Diamond Burrs because diamond particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.

    Product
    GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; Product Usage: The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2017·2017-05-24

    Medline 16 mm Distraction Pin Recalled Due to Sterile Seal Integrity

    Medline Industries is recalling 198 packs of 16 mm Distraction Pins because the sterile packaging seal may be compromised, risking loss of sterility.

    Product
    16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2017·2017-05-24

    Medline 14 mm Distraction Pin Recalled for Potential Sterility Loss

    Medline Industries is recalling 14 mm Distraction Pins due to potential sterile packaging seal failures that could compromise device sterility.

    Product
    14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2017·2017-05-24

    Bausch & Lomb Recalls SoftPort Easy-Load Lens Delivery System

    Bausch & Lomb is recalling specific lots of the SoftPort Easy-Load Lens Delivery System due to reports of kinked haptics during lens delivery.

    Product
    SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2017·2017-05-24

    Mobius3D Software Recalled for Dose Calculation Defect in Radiation Therapy

    Mobius Medical Systems is recalling Mobius3D software versions 1.5.0 and 1.5.2 due to a code defect that may cause dose calculation discrepancies in radiation therapy.

    Product
    Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2017·2017-05-24

    Vortran Automatic Resuscitator Recalled Due to Reverse-Threaded Oxygen Connector

    Vortran is recalling 14 cases of VARPlus Automatic Resuscitators because the oxygen tubing connector was assembled in reverse, preventing it from being screwed on.

    Product
    VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2110-2017·2017-05-24

    Molnlycke Recalls Brennen Skin Graft Mesher Due to Sterilization Failure

    Molnlycke Health Care is recalling 956 units of the Brennen Skin Graft Mesher because of a sterilization validation failure. The instruments were distributed domestically and internationally.

    Product
    Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2017·2017-05-24

    Medline Recalls 10 mm Distraction Pins Due to Sterile Seal Concerns

    Medline Industries is recalling 10 mm Distraction Pins because the sterile packaging seal may be compromised, potentially causing the device to lose sterility.

    Product
    10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2017·2017-05-24

    Luminex ARIES System Recalled for Barcode Scanner Data Error

    Luminex Corporation is recalling 15 ARIES Systems because a barcode scanner accessory may incorrectly populate patient sample IDs with previously scanned data.

    Product
    ARIES System and ARIES M1 System
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2042-2017·2017-05-17

    Arthrex Recalls Anthrex PEEK SwiveLock SP Vented Anchors Due to Breakage

    Arthrex, Inc. is recalling specific Anthrex PEEK SwiveLock SP Vented anchors because some eyelets broke during insertion. The recall covers units distributed in the US and several international locations.

    Product
    Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2045-2017·2017-05-17

    Arthrex SpeedBridge Implant System Recalled for Broken Eyelets

    Arthrex is recalling specific SpeedBridge Implant Systems because some eyelets broke during insertion. The recall covers multiple batches distributed in the US and internationally.

    Product
    Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2050-2017·2017-05-17

    Mederi Stretta Catheter Recalled Due to Sterility Compromise

    Mederi Therapeutics is recalling 1,458 Stretta Catheter kits because a breach in the sterile barrier package compromised sterility.

    Product
    Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2068-2017·2017-05-17

    Zimmer Biomet Recalls Regenerex Patella Implants Due to Peg Shearing

    Zimmer Biomet is recalling 8,154 Regenerex Series A Patella implants because the pegs may shear after surgery.

    Product
    Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2017·2017-05-17

    Abbott Recalls Healon Medical Device Due to Glass Particle Risk

    Abbott Medical Optics is recalling Healon medical devices because certain lots may contain microscopic glass particles from manufacturing damage.

    Product
    Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2066-2017·2017-05-17

    Abbott Recalls Healon Pro Due to Possible Glass Particles

    Abbott Medical Optics is recalling Healon Pro ophthalmic solutions because manufacturing damage may have introduced microscopic glass particles.

    Product
    Healon Pro, Part No. 10270012
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2064-2017·2017-05-17

    Abbott Recalls Healon Duet Due to Potential Glass Particles

    Abbott Medical Optics is recalling Healon Duet units because they may contain microscopic glass particles from manufacturing damage.

    Product
    Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2049-2017·2017-05-17

    Roche Diagnostics Recalls Sample Probes for Corrosion-Related Liquid Level Detection Issues

    Roche Diagnostics is recalling 3,946 sample probes for cobas analyzers because corrosion on electrical contacts can disrupt liquid level detection, potentially causing sample carryover.

    Product
    Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2017·2017-05-17

    Arthrex Recalls Anthrex SpeedBridge Implant System Due to Broken Eyelets

    Arthrex, Inc. is recalling the Anthrex SpeedBridge Implant System because some eyelets broke from the SwiveLock Anchor during insertion.

    Product
    Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2063-2017·2017-05-17

    Abbott Recalls Healon GV Due to Possible Microscopic Glass Particles

    Abbott Medical Optics is recalling Healon GV due to a remote possibility of microscopic glass particles from manufacturing damage.

    Product
    Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2065-2017·2017-05-17

    Abbott Recalls Healon 5 Pro Due to Possible Glass Particles

    Abbott Medical Optics is recalling Healon 5 Pro ophthalmic solution because some units may contain microscopic glass particles from manufacturing damage.

    Product
    Healon 5 Pro, Part No. 10270015
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2041-2017·2017-05-17

    Arthrex Bio-SwiveLock SP Vented Anchor Recall Due to Broken Eyelets

    Arthrex, Inc. is recalling specific Bio-SwiveLock SP Vented anchors because some eyelets broke during insertion.

    Product
    Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2055-2017·2017-05-17

    Greatbatch Medical Recalls Linear Straight Broach Handles Due to Weld Breakage

    Greatbatch Medical is recalling specific Linear Straight Broach Handles because they may break at the welds or lose the locating pin during use.

    Product
    Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
    Category
    Medical Device
    Distribution
    1 state