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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20726–20750 of 27682

  • HighFDA (Devices)·Z-0346-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0332-2017·2016-11-09

    Spacelabs Xhibit Central Station Recalled for Telemetry Display Issues

    Spacelabs Healthcare is recalling 348 Xhibit Central Station units because telemetry SpO2 numerics may drop off the display, though alarms function normally.

    Product
    Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0355-2017·2016-11-09

    Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk

    Unomedical As is recalling 1.3 million Comfort infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0340-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0356-2017·2016-11-09

    Unomedical Recalls Insulin Infusion Sets Due to Tubing Detachment Risk

    Unomedical As is voluntarily recalling 664,000 Contact Detach infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0339-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0324-2017·2016-11-09

    Stryker Recalls Reprocessed Pressure Tourniquet Cuffs Due to Leak Detection Issues

    Stryker Sustainability Solutions is recalling 1,695,760 reprocessed pressure tourniquet cuffs because the process for detecting leaks is flawed. Leaking cuffs may cause excessive blood loss or systemic leakage of local anesthetic.

    Product
    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2017·2016-11-09

    Maquet HCU 30 Heater-Cooler Units Recalled for Bacterial Contamination Risk

    Maquet Cardiovascular is recalling 305 HCU 30 units because contaminated water, including Mycobacteria, may enter the device circuits.

    Product
    Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2017·2016-11-09

    Stryker Recalls Guider Guide Catheters Due to Manufacturing Defect

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing non-conformance that could lead to hub leaks.

    Product
    Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0341-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0347-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks in the devices.

    Product
    Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0350-2017·2016-11-09

    Smith & Nephew Recalls Tandem Hip Shells With Out-of-Specification Grooves

    Smith & Nephew is recalling 2,352 Tandem hip shells manufactured with out-of-specification retainer grooves. The recall covers units distributed nationwide and in 23 other countries.

    Product
    TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2017·2016-11-09

    Unomedical Recalls SureT G29 Insulin Infusion Pump Tubing Due to Detachment Risk

    Unomedical As is voluntarily recalling SureT G29 insulin infusion pump tubing because it may detach. The recall covers 4,748,000 units distributed in the US and internationally.

    Product
    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0353-2017·2016-11-09

    Hospira Recalls Symbiq Infusion Pumps Due to Backup Battery Failure

    Hospira is recalling 20,311 Symbiq One Channel Infusion Pumps due to a backup battery failure caused by incorrect component installation on some power supply boards.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2017·2016-11-09

    Smith & Nephew Recalls Tandem Hip Shells With Out-of-Specification Grooves

    Smith & Nephew is recalling 5,806 Tandem hip shell units manufactured with out-of-specification retainer grooves. The recall covers distribution in the US and 23 other countries.

    Product
    TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2017·2016-11-09

    Unomedical Silhouette Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling Silhouette and Silhouette Paradigm insulin infusion tubing due to a risk of tubing detachment. The recall affects approximately 9.8 million units distributed in the US and internationally.

    Product
    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0329-2017·2016-11-09

    Azer Scientific Recalls Glucose Tolerance Beverage Due to Microbiological Test Failures

    Azer Scientific, Inc. is recalling 426 cases of Orange Glucose Tolerance Beverage due to out-of-specification microbiological test results.

    Product
    Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2017·2016-11-09

    Medtronic Visualase Body Accessory Kit Recalled for MRI Safety Hazard

    Medtronic Navigation is recalling Visualase Body Accessory Kits because the visualization stylet bends in MRI magnetic fields.

    Product
    Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0086-2017·2016-11-09

    Epimed 15 g R.K. Epidural Needle Recall for Catheter Coating Risk

    Epimed International is recalling 576 units of 15 g R.K. Epidural Needles because they may skive a catheter's outer coating, posing a risk of retained catheter fragments.

    Product
    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-0116-2017·2016-11-02

    St Jude Medical Recalls Implantable Defibrillators Due to Battery Defect

    St Jude Medical is recalling specific implantable defibrillators because a lithium cluster in the battery can cause a short circuit and premature depletion.

    Product
    Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0097-2017·2016-11-02

    Roche Recalls cobas 8000 Analyzers Due to Sharp Edge Injury Reports

    Roche is recalling cobas 8000 Modular Analyzers and e602 Immunoassay Analyzers after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0300-2017·2016-11-02

    Ortho-Clinical Diagnostics Recalls enGen Laboratory Automation System Due to Sample Error

    Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System because a software error may cause sample identification to be mismatched with assay results.

    Product
    enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0109-2017·2016-11-02

    Roche Recalls cobas p 312 Pre-Analytical System Calculator Modules

    Roche is recalling 9,014 cobas p 312 Pre-Analytical System calculator/data processing modules due to four reported injuries caused by a sharp edge on the sample rack tray.

    Product
    cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0101-2017·2016-11-02

    Roche Recalls cobas p 701 Post-Analytical Units Due to Sharp Edges

    Roche is recalling 9,014 cobas p 701 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0107-2017·2016-11-02

    Roche Recalls cobas p 512 Pre-Analytical Instrument Due to Sharp Edge Injury Reports

    Roche is recalling 9,014 cobas p 512 Pre-Analytical Instruments after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in…
    Category
    Medical Device
    Distribution
    Distributed nationwide