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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31426–31450 of 40325

  • 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
  • HighFDA (Devices)·Z-0364-2016·2015-12-09

    Philips BuckyDiagnost Patient Support Material Recall for Footplate Safety

    Philips Medical Systems is recalling BuckyDiagnost patient support materials because the footplate hook may fail, causing the plate to fall or swing and injure patients or operators.

    Product
    Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0348-2016·2015-12-09

    Philips INTEGRIS Cardio System Ceiling Suspension Recall

    Philips is recalling eight INTEGRIS cardio systems because the ceiling suspension system may fall.

    Product
    Philips Healthcare INTEGRIS cardio system Model : 722121 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-0365-2016·2015-12-09

    Philips EasyDiagnost Patient Support Material Recalled for Footplate Safety Hazard

    Philips Medical Systems is recalling patient support materials for the EasyDiagnost device because the footplate hook may fail, causing the footplate to fall or swing and potentially injure patients or operators.

    Product
    Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0342-2016·2015-12-09

    Medtronic InSync III Pacemaker Recall for Battery Impedance Issue

    Medtronic is recalling InSync III pacemakers due to unexpected high battery impedance affecting long-term performance.

    Product
    Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2016·2015-12-09

    Philips Xper Vascular System Recall for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling 10 Xper vascular systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper vascular system Model : 722124 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-0357-2016·2015-12-09

    Carl Zeiss IOL Master 5.5 Software Recall for Incorrect Data

    Carl Zeiss Meditec AG is recalling IOL Master 5.5 software versions 7.5 and 7.7 because printouts and reports may contain incorrect IOL power data.

    Product
    IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2016·2015-12-09

    Philips Allura X-Ray System Ceiling Suspension Recall

    Philips Medical Systems is recalling INTEGRIS H5000F/Allura 9F X-ray systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 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
  • HighFDA (Devices)·Z-0346-2016·2015-12-09

    Philips Allura Xper Series Recall Due to Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling nine Allura Xper Series units because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2016·2015-12-09

    Philips Allura BiPlane Ceiling Suspension System Recall for Fall Risk

    Philips Medical Systems is recalling five Allura BiPlane X-ray systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLANE R7.9 722013 Allura Xper FD20 BIPLANE R7.10 Product Usage: The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2016·2015-12-09

    Quest Medical MPS Delivery Sets Recalled for Intermittent Seal Failure

    Quest Medical, Inc. is recalling specific MPS Delivery Sets used with cardiopulmonary bypass equipment due to intermittent seal failures during use.

    Product
    Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2016·2015-12-09

    DeRoyal and GEO-MED sterile surgical kits recalled for seal defects

    DeRoyal Industries is recalling 836 sterile custom surgical kits because a component may have packaging seal defects that compromise sterility.

    Product
    DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0344-2016·2015-12-09

    Stryker Recalls I.V. Poles Due to Unexpected Retraction Hazard

    Stryker is recalling 19,876 I.V. poles because a nonconforming latch housing may cause them to retract unexpectedly while holding medical equipment.

    Product
    Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0359-2016·2015-12-09

    ConMed Recalls Altrus Thermal Tissue Fusion Energy Sources

    ConMed is recalling nine Altrus Thermal Tissue Fusion Energy Sources due to a miscalibration issue that may cause false alarms and stop heating cycles.

    Product
    Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0362-2016·2015-12-09

    Stryker Duracon Tibial Wedge Implants Recalled for Packaging Integrity Issues

    Stryker is recalling 2,577 Duracon Tibial Wedge implants because they punctured the packaging's Tyvek lids, potentially compromising sterility.

    Product
    Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0366-2016·2015-12-09

    Merz Recalls Radiesse Injectable Implant Due to Incorrect Expiration Date

    Merz North America is recalling 1,616 units of Radiesse (+) Lidocaine Injectable Implant because the expiration date on the packaging is incorrect.

    Product
    Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
    Category
    Medical Device
    Distribution
    Distributed nationwide