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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31501–31525 of 40449

  • 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
  • ModerateFDA (Devices)·Z-0386-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling specific embolectomy catheters because a manufacturing defect could compromise sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

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

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0387-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling Single Lumen Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0351-2016·2015-12-09

    Philips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling 16 Allura Xper cardio systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0354-2016·2015-12-09

    Philips Xper Vascular System Monitor Ceiling Suspension Recall

    Philips Medical Systems is recalling 22 Allura Xper vascular systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0353-2016·2015-12-09

    Philips Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling 14 Allura Xper Cardio systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0349-2016·2015-12-09

    Philips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling three INTEGRIS vascular systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2016·2015-12-09

    DeRoyal Recalls Neonatal Temperature Skin Sensors Due to Soldering Defect

    DeRoyal Industries is recalling four lots of Hydro-Temp Neonatal Temperature Skin Sensors because incorrect soldering prevents temperature readings on infant warming systems.

    Product
    HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0356-2016·2015-12-09

    Baylis ProTrack Microcatheter Recalled for Circumferential Shaft Cracks

    Baylis Medical Corp is recalling 433 ProTrack Microcatheters nationwide due to circumferential cracks along the shaft.

    Product
    ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2016·2015-12-09

    Carl Zeiss IOL Master 500 Software Recall for Incorrect IOL Power Data

    Carl Zeiss Meditec is recalling IOL Master 500 software versions 7.5 and 7.7 because calculation printouts and exported reports may contain incorrect intraocular lens power data.

    Product
    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide