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

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31401–31425 of 40325

  • HighFDA (Devices)·Z-0396-2016·2015-12-16

    Implant Direct Sybron Recalls DirectGuide Drill Extender for Dental Implants

    Implant Direct Sybron Manufacturing is recalling 26 lots of DirectGuide Drill Extenders because the drill may drop during use.

    Product
    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2016·2015-12-16

    Boston Scientific Recalls One Step Button PEG Kits Due to Adapter Defect

    Boston Scientific is voluntarily recalling specific lots of One Step Button PEG kits because a protrusion on the decompression tube adapter may prevent the device from being inserted or removed.

    Product
    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0411-2016·2015-12-16

    Zimmer Persona EM Distal Rod Recalled for Ratchet Latching Defect

    Zimmer, Inc. is recalling 156 Persona EM Distal Rods because the ratchet teeth may not latch onto the rod. The defect could affect the stability of the surgical instrument during use.

    Product
    Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0380-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recall for Packaging Defect

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2016·2015-12-16

    Zimmer Persona EM Proximal Tube Recalled for Ratchet Latching Failure

    Zimmer, Inc. is recalling 156 Persona EM Proximal Tubes because the ratchet teeth may not latch onto the rod.

    Product
    Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0404-2016·2015-12-16

    Sterilmed Recalls Reprocessed Tourniquet Cuffs Due to Sterility Concerns

    Sterilmed is voluntarily recalling reprocessed tourniquet cuffs because the company cannot assure the sterility of all units in the affected lots.

    Product
    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2016·2015-12-16

    GE Revolution CT Scanners Recalled for Potential Head Scan Artifacts

    GE Medical Systems is recalling 125 Revolution CT scanners worldwide due to potential image artifacts in head scans that may mimic pathology. No injuries have been reported.

    Product
    GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that could compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2016·2015-12-16

    Philips Brilliance CT Scanner Software Recall for Incorrect Tumor Localization

    Philips is recalling Brilliance CT scanners with software version 2.0 because a printing error may display incorrect tumor locations, potentially leading to patient mistreatment.

    Product
    Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0399-2016·2015-12-16

    Visicu eCareManager Software Recalled for Medication Order Defect

    Visicu, Inc. is recalling 43 units of eCareManager software due to a defect that may cause incorrect medication orders to be displayed and signed.

    Product
    The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0388-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 embolectomy catheters worldwide due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2016·2015-12-16

    Olympus ENDOEYE HD II Video Telescopes Recalled Due to Overheating Tip

    Olympus is recalling 182 ENDOEYE HD II video telescopes because a damaged temperature sensor can cause the tip to overheat, posing a burn risk to patients and users.

    Product
    Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2016·2015-12-16

    In2Bones Recalls Osteosynthesis Screws with Incorrect Torx Imprint

    In2Bones is recalling 20 units of Model S25 ST014 osteosynthesis screws distributed in Tennessee because they were manufactured with the incorrect Torx imprint on the screw head.

    Product
    IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0389-2016·2015-12-16

    LeMaitre NovaSil Silicone Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 units of NovaSil Silicone Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0381-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0391-2016·2015-12-16

    BioHorizons Dental Implant Recalled Due to Incorrect Length Labeling

    BioHorizons is recalling 32 units of 5.0 x 15mm dental implants because the packaging incorrectly listed the length as 10.5mm.

    Product
    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0390-2016·2015-12-16

    LeMaitre NovaSil Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling NovaSil Embolectomy Catheters due to a manufacturing issue that could compromise packaging sterility.

    Product
    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters worldwide due to a manufacturing defect that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0398-2016·2015-12-16

    Edwards Thin-Flex Venous Cannula Recalled for Incorrect Connector Size Labeling

    Edwards Lifesciences is recalling Thin-Flex Venous Cannulas because the product guide incorrectly lists the connector size as 3/8 inch instead of the actual 1/2 inch.

    Product
    Thin-Flex Venous Cannula, Model Number:TF292902A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0371-2016·2015-12-16

    Valeant SPAG-2 6000 Aerosol Generator Recalled for Missing Particle Size Testing

    Valeant Pharmaceuticals is recalling 61 units of the SPAG-2 6000 aerosol generator because they were released without required particle size testing.

    Product
    Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0395-2016·2015-12-16

    Powers Medical Devices Recalls Pacifier Activated Lullaby Systems for Labeling Issues

    Powers Medical Devices is recalling 128 Pacifier Activated Lullaby (PAL) Systems because the units' labeling is inconsistent with their FDA-cleared indications.

    Product
    The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0372-2016·2015-12-16

    Smith & Nephew Recalls Anatomically Incorrect Volar Distal Radius Plates

    Smith & Nephew is recalling 9 units of PERI-LOC Volar Distal Radius Plates that were laser marked and packaged with incorrect anatomical orientation.

    Product
    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0373-2016·2015-12-16

    Smith & Nephew Volar Distal Radius Plates Recalled for Incorrect Marking

    Smith & Nephew is recalling 9 units of PERI-LOC VOLAR DISTAL RADIUS PLATES because they were laser marked and packaged with incorrect anatomical orientation.

    Product
    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0377-2016·2015-12-16

    Windstone AMS 4675 Angio Pack Recalled Due to Component Issue

    Windstone Medical Packaging is recalling 40 kits of the AMS 4675 Angio Pack because they contain a recalled Seldinger Needle.

    Product
    AMS 4675 Angio Pack. For use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    2 states