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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Minimum severity

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

Clear filters

34551–34575 of 40449

  • LowFDA (Devices)·Z-0208-2015·2014-11-19

    CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date

    CooperSurgical is recalling 6 units of MILEX Pessary Kits due to incorrect expiration dates printed on the packaging.

    Product
    CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary…
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0156-2015·2014-11-12

    Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect

    Terumo is recalling specific Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0125-2015·2014-11-12

    TriVascular Recalls Ovation Prime Abdominal Stent Grafts Due to Injection Issue

    TriVascular is recalling specific lots of Ovation Prime Abdominal Stent Grafts because the fill polymer syringe may empty rapidly during the implant procedure.

    Product
    Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0084-2015·2014-11-12

    Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path

    Baxter Healthcare Corp is recalling 94,224 INTRA VIA containers due to particulate matter found inside the fluid path.

    Product
    Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0085-2015·2014-11-12

    Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path

    Baxter Healthcare is recalling 20,448 units of INTRA VIA containers due to particulate matter found inside the fluid path.

    Product
    Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0168-2015·2014-11-12

    IBA Dosimetry Recalls COMPASS Software Due to Dose Calculation Errors

    Iba Dosimetry Gmbh is recalling COMPASS software version 3.1 because a defect may prevent detection of dose distribution errors, potentially leading to incorrect radiation doses during treatment.

    Product
    COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0159-2015·2014-11-12

    Terumo Cardiovascular Procedure Kits Recalled for Luer Connector Defect

    Terumo is recalling specific cardiovascular and perfusion procedure kits because a luer connector defect may compromise the seal and introduce air into the table line.

    Product
    Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2015·2014-11-12

    Cynosure Elite XPL Handpiece Recalled for Electrical Shock Risk

    Cynosure, Inc. is recalling 322 Elite XPL handpieces for the Elite MPX Laser System due to a potential risk of electrical shock when the device is adjusted or removed while powered on.

    Product
    Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2015·2014-11-12

    Dokitz NovoSci Recalls Cardiopulmonary Bypass Connectors Due to Detachment Risk

    Dokitz NovoSci is recalling 240 units of cardiopulmonary bypass connectors because the single leg of the PAY connector has been observed to become detached.

    Product
    Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0157-2015·2014-11-12

    Terumo Cardioplegia Delivery Set Line Recalled for Luer Connector Defect

    Terumo is recalling 165 units of a cardioplegia delivery set line because a luer connector defect can compromise the seal and introduce air into the line.

    Product
    Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2015·2014-11-12

    Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect

    Terumo is recalling 777 Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2015·2014-11-12

    Terumo Custom Cardioplegia Delivery Set Recalled for Luer Connector Defect

    Terumo is recalling Custom Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2015·2014-11-12

    Terumo Custom Cardioplegia Delivery Sets Recalled for Luer Connector Seal Defect

    Terumo is recalling 24 units of Custom Cardioplegia Delivery Sets because a luer connector defect may compromise the seal and introduce air into the line.

    Product
    Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2015·2014-11-12

    Zimmer Surgical Recalls Universal Modular Electric Handpieces Due to Malfunction

    Zimmer Surgical Inc is recalling 828 Universal Modular Electric/Battery Handpieces because a malfunction allows them to start unexpectedly when connected to a power source.

    Product
    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2015·2014-11-12

    Stryker SmartLife Aseptic Housings Recalled for Welding Defect

    Stryker is recalling SmartLife Large Aseptic Housings because the top section may separate from the bottom due to insufficient welding.

    Product
    Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2015·2014-11-12

    C.R. Bard Recalls 86 Non-Sterile Bard Dimension Stone Baskets

    C.R. Bard is recalling 86 non-sterile Bard Dimension Stone Baskets due to a Class II recall classification.

    Product
    Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0173-2015·2014-11-12

    Stryker SmartLife Aseptic Housings Recalled for Welding Defect

    Stryker is recalling SmartLife Small Aseptic Housings because the top section may separate from the bottom due to insufficient welding.

    Product
    Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2015·2014-11-12

    St. Jude Medical Recalls Electrophysiology Catheters Due to Incorrect Packaging

    St. Jude Medical is voluntarily recalling 26 electrophysiology catheters because the packaging contains the wrong device model. No serious injuries have been reported.

    Product
    St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0176-2015·2014-11-12

    Beckman Coulter Recalls DxC 600i Analyzer Console PC Due to Error

    Beckman Coulter is recalling the Small Form Factor Console PC for the DxC 600i analyzer because it may experience an 'MFC Exception' error during normal operation.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0179-2015·2014-11-12

    Leica Thyroglobulin Antibody Recalled for Reduced Performance

    Leica Microsystems is recalling Thyroglobulin (1D4) antibodies because they may not function as intended up to the expiration date.

    Product
    Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use.…
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0175-2015·2014-11-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Software Error

    Beckman Coulter is recalling Access 2 Immunoassay Systems because the Small Form Factor Console PC may experience an 'MFC Exception' error during normal operation.

    Product
    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0174-2015·2014-11-12

    Straumann Dental Implant Recall Due to Incorrect Product Transfer Piece

    Straumann USA is recalling 111 units of Bone Level Implants because the product transfer piece was fitted with a Narrow Connect instead of a Regular Connect.

    Product
    Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2015·2014-11-12

    Smiths Medical Recalls CADD-Solis Medication Safety Software Administrator CD

    Smiths Medical is recalling a specific lot of CADD-Solis Medication Safety Software Administrator CDs because they were shipped with incorrect software loaded.

    Product
    CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2015·2014-11-12

    Merit Maestro Microcatheter Recalled for Incorrect Distal Tip Size

    Merit Medical Systems is recalling 56 Maestro Microcatheters because they were packaged with a 2.8 F distal tip instead of the labeled 2.4 F.

    Product
    Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide