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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18926–18950 of 27682

  • HighFDA (Devices)·Z-0385-2018·2018-01-24

    Fujifilm Aspire HD Plus Mammography Machines Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire HD Plus and HD-s mammography machines because the swivel arm may drop unintentionally.

    Product
    Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0381-2018·2018-01-24

    Owen Mumford Recalls Unifine Pentips Due to Potential Sterility Compromise

    Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Users should check for discoloration or yellowing of the protective seal.

    Product
    Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2018·2018-01-24

    Philips Recalls ECG Out Cables Due to Electrical Interference Risk

    Philips is recalling specific ECG out and sync cables because electrical interference may cause monitors to misinterpret signals or disable monitoring.

    Product
    ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0159-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 130,740 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0293-2018·2018-01-17

    Edwards Certitude Delivery System Recalled for Molding Overflow Defect

    Edwards Lifesciences is recalling 1,730 units of the Certitude Delivery System due to a molding overflow defect that could detach and embolize into patients.

    Product
    Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA)…
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0157-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 29,232 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0160-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 96,828 bottles of sterile eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005587
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0330-2018·2018-01-17

    Philips CombiDiagnost R90 X-Ray System Recalled for Electrical Safety Defect

    Philips is recalling 10 CombiDiagnost R90 X-ray systems because a protective earthing wire was removed and non-standard spacers were used.

    Product
    CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0158-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 22,080 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005583
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0294-2018·2018-01-17

    Physio-Control Recalls LIFEPAK 20e Defibrillators Due to Power Failures

    Physio-Control is recalling 3,831 LIFEPAK 20e defibrillators because power-related failures could prevent the device from delivering therapy, potentially causing serious injury or death.

    Product
    LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0328-2018·2018-01-17

    Encore Medical Recalls EMPOWR Porous Knee System Tibial Punch

    Encore Medical is recalling two units of the EMPOWR Tibial Punch because the guide did not sufficiently direct the punch, causing implants to be placed further back than intended.

    Product
    EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0322-2018·2018-01-17

    CareFusion Recalls Alaris Syringe Pumps Due to Plunger Gripper Failure

    CareFusion is recalling Alaris Syringe Pump Model 8110 units because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

    Product
    Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2018·2018-01-17

    Cordis S.M.A.R.T. Flex Biliary Stent System Recalled for Cracked Luer Hubs

    Cordis Corporation is recalling 511 units of the S.M.A.R.T. Flex Biliary Stent System due to a potential for cracked luer hubs.

    Product
    Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0332-2018·2018-01-17

    Philips Brilliance iCT SP CT Scanner Recall Due to Loose Screws

    Philips is recalling 134 Brilliance iCT SP CT scanners because screws holding the internal gantry may come loose, potentially causing noise.

    Product
    Philips Healthcare Brilliance iCT SP computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0329-2018·2018-01-17

    Encore Medical Recalls EMPOWR Porous Knee System Tibial Punch

    Encore Medical is recalling two units of the EMPOWR Porous Knee System Tibial Punch because the locking guide failed to properly guide the punch, causing implants to be placed 2-3mm more posterior than intended.

    Product
    EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0258-2018·2018-01-17

    Orthoscan Mobile Mini C-arm System Recalled for Software Defect

    Orthoscan is recalling Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than is visible to the user.

    Product
    Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2018·2018-01-17

    Orthoscan Mobile Mini C-arm System Recalled for Software Defect

    Orthoscan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than is visible to the user.

    Product
    Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2018·2018-01-17

    Ambu Universal Flex2 Breathing Circuits Recalled for Leak Test Failures

    King Systems Corp. dba Ambu, Inc. is recalling 871,116 Universal Flex2 Breathing Circuits due to potential leak test failures.

    Product
    UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z…
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0326-2018·2018-01-17

    Encore Medical Recalls DJO EMPOWR Knee Locking Tibial Punch Guide

    Encore Medical is recalling 2 units of the DJO EMPOWR Knee Locking Tibial Punch Guide because the device did not sufficiently guide the punch, causing implants to be placed 2-3mm more posterior than intended.

    Product
    DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0261-2018·2018-01-17

    OrthoScan Recalls Mobile Mini C-arm Systems Due to Software Defect

    OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.

    Product
    Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2018·2018-01-17

    Philips Brilliance iCT CT Scanner Recall Due to Potential Gantry Screw Failure

    Philips is recalling 702 Brilliance iCT computed tomography systems because screws holding an internal gantry component may come loose, potentially causing noise.

    Product
    Philips Healthcare Brilliance iCT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0318-2018·2018-01-17

    Repro-Med HIgH-Flo Subcutaneous Safety Needle Sets Recalled for Packaging Defects

    Repro-Med Systems is recalling HIgH-Flo Subcutaneous Safety Needle Sets because gaps were found in the sterile barrier packaging during post-sterilization inspection.

    Product
    HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612…
    Category
    Medical Device
    Distribution
    Distributed nationwide