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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27776–27800 of 40233

  • HighFDA (Devices)·Z-1056-2017·2017-01-25

    Baxter Peritoneal Dialysis Set Recalled for Reported Leaks

    Baxter Healthcare is recalling 8,640 APD Set with Cassette 3-Prong Peritoneal Dialysis Sets due to customer complaints about leaks.

    Product
    APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1033-2017·2017-01-25

    Meridian Premier EHEC Diagnostic Kits Recalled for False Positive Results

    Meridian Bioscience is recalling Premier EHEC and Premier EHEC Bulk diagnostic kits because internal testing showed they can produce false positive results with some broth specimens.

    Product
    PREMIER EHEC and PREMIER EHEC Bulk.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-1034-2017·2017-01-25

    Ultradent NanoTips 30g Dental Tips Recalled for Loose Cannula

    Ultradent Products, Inc. is recalling NanoTips 30g dental tips because the stainless steel cannula may detach from the base, posing a risk during intra-oral procedures.

    Product
    NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2017·2017-01-25

    Fresenius 2008K2 Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008K2 hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.

    Product
    Fresenius 2008K2 Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1031-2017·2017-01-25

    Exactech Recalls Polyethylene Acetabular Liners Due to Incorrect GTIN Labels

    Exactech, Inc. is recalling 12 polyethylene acetabular liners because they were labeled with incorrect Global Trade Item Numbers (GTINs).

    Product
    AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1025-2017·2017-01-25

    Zimmer Biomet Recalls ArComXL Polyethylene Bearings Due to Labeling Mismatch

    Zimmer Biomet is recalling 19 ArComXL Polyethylene Bearings because packaging labels did not match the physical product inside, posing a risk of surgical delay.

    Product
    Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1032-2017·2017-01-25

    Exactech Recalls Alteon Neck Preserving Stems Due to Incorrect GTIN Labels

    Exactech is recalling 98 Alteon Neck Preserving Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs) that identify them as different devices.

    Product
    Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1023-2017·2017-01-25

    Medacta M.U.S.T. Rods Recalled for Damaged Packaging and Sterility Issues

    Medacta USA Inc. is recalling 82 M.U.S.T. Rods due to damaged packaging and lack of sterility assurance. The recall covers units distributed in the US and several international countries.

    Product
    Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1039-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Update

    Endologix is updating the Instructions for Use and implementing modifications to the AFX Endovascular AAA System.

    Product
    AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1038-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Update

    Endologix updated the Instructions for Use for the AFX Endovascular AAA System to address endoleak Type IIIB.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1055-2017·2017-01-25

    Binding Site Digital RID Plate Reader Recalled for Software Defect

    The Binding Site Group is recalling Digital RID Plate Readers and software because a defect may prevent the system from flagging out-of-range quality control results.

    Product
    Digital RID Plate Reader and Software Product Code: AD400
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1050-2017·2017-01-25

    Binding Site Freelite Human Lambda Free SPAPlus Kit Recalled for Calibration Drift

    The Binding Site Group is recalling 1,002 units of the Freelite Human Lambda Free SPAPlus Kit because calibration curve activity increased over time.

    Product
    Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1049-2017·2017-01-25

    Endologix AFX2 Endovascular AAA System Recall for Updated Endoleak Information

    Endologix is recalling the AFX2 Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.

    Product
    AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1040-2017·2017-01-25

    Beckman Coulter AutoMate 2500 Family Recalled for Operating System Update

    Beckman Coulter is recalling four AutoMate 2500 Family units in Maryland to update the PC image for Windows 10 compatibility.

    Product
    AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1024-2017·2017-01-25

    Zimmer Biomet Recalls ArComXL Polyethylene Liners Due to Labeling Mismatch

    Zimmer Biomet is recalling 36 units of ArComXL polyethylene liners because packaging labels did not match the physical product, posing a risk of surgical delay.

    Product
    RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1052-2017·2017-01-25

    Carestream Ultrasound Systems Recalled for Software Measurement Unit Error

    Carestream Health Inc. is recalling Touch Prime and Touch Prime XE ultrasound systems due to a software error that may display incorrect measurement units.

    Product
    Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1037-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Updated

    Endologix updated the Instructions for Use and modified the AFX Endovascular AAA System. The correction applies to procedures conducted after July 2015.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1047-2017·2017-01-25

    Endologix Updates Instructions for Use for AFX Endovascular AAA System

    Endologix is updating the Instructions for Use and making modifications to the AFX Endovascular AAA System. This applies to procedures conducted after October 2015.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1043-2017·2017-01-25

    Optilite Freelite Lambda Free Kit Recalled for Inaccurate Test Results

    The Binding Site Group is recalling 809 Optilite Freelite Lambda Free Kits because specific lots produce test results that are approximately 33% lower than expected.

    Product
    Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1054-2017·2017-01-25

    Endologix Updates Instructions for Use for AFX Endovascular AAA System

    Endologix is recalling 17,139 units of the AFX Endovascular AAA System to update the Instructions for Use and implement device modifications.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1048-2017·2017-01-25

    Endologix AFX Endovascular AAA System Recall for Updated Endoleak Information

    Endologix is recalling 34 units of the AFX Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.

    Product
    AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1035-2017·2017-01-25

    Endologix AFX Endovascular AAA System Clinical Data Correction

    Endologix is correcting cumulative clinical data reports for the AFX Endovascular AAA System and Powerlink System. This action applies to procedures conducted after June 2013.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIA
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1045-2017·2017-01-25

    DICOM GRID Recalls Ambra PACS Software Due to Image Display Error

    DICOM GRID Inc. is recalling Ambra PACS software version V3.16.13.0 because a defect causes diagnostic images to appear washed out, potentially affecting image analysis.

    Product
    Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1041-2017·2017-01-25

    Smith & Nephew RENASYS GO Wound Therapy Recall for Clearance Issue

    Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy devices because they lack 510(k) clearance for a design modification.

    Product
    Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1042-2017·2017-01-25

    Smith & Nephew RENASYS GO Power Supply Recalled for Regulatory Clearance

    Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy External Power Supply Units because they lack 510(k) clearance for a design modification.

    Product
    Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious…
    Category
    Medical Device
    Distribution
    Distributed nationwide