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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37476–37500 of 40449

  • HighFDA (Devices)·Z-2277-2013·2013-10-02

    Elekta Recalls Monaco RTP System Radiation Therapy Treatment Planning System

    Elekta, Inc. is recalling 72 units of the Monaco RTP System Radiation Therapy Treatment Planning System because patients must be positioned as indicated by the treatment plan.

    Product
    Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-2265-2013·2013-10-02

    Endoplus 5 mm Traumatic Grasper Recalled for Broken Jaw

    Endoplus is recalling 9 units of 5 mm Traumatic Graspers because the moveable jaw broke during laparoscopic procedures.

    Product
    ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2284-2013·2013-10-02

    Medtronic Xomed Recalls Universal Titanium Ear Prosthesis Due to Assembly Error

    Medtronic Xomed is recalling 60 units of Universal Titanium Prosthesis because one lot was assembled with the wrong component.

    Product
    Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2268-2013·2013-10-02

    Smiths Medical Recalls PORT-A-CATH Introducer Sets Due to Sizing Issues

    Smiths Medical is voluntarily recalling PORT-A-CATH Introducer Sets because the sheath opening may be too small for the catheter width.

    Product
    Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of…
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2278-2013·2013-10-02

    Synthes 3.5 MM LCP Distal Humerus System Recalled for Mislabeled Part Numbers

    Synthes USA HQ, Inc. is recalling two units of the 3.5 MM LCP Distal Humerus System because the part was mislabeled with an incorrect part number.

    Product
    Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2279-2013·2013-10-02

    CareFusion Recalls SmartSite Infusion Sets Due to Incorrect Filter Assembly

    CareFusion is recalling 600 units of SmartSite Low Sorbing Infusion Sets because an incorrect 0.2 micron filter may have been assembled instead of the required 1.2 micron filter.

    Product
    SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2266-2013·2013-10-02

    GE Healthcare Recalls MRI Scanners Due to Non-Unique Series Identifiers

    GE Healthcare is recalling specific MRI scanners because they may generate non-unique series identifiers in image headers, which can cause data association errors when exported to PACS systems.

    Product
    GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2283-2013·2013-10-02

    Stryker FL23SE Hospital Bed Recall for Nurse Call Cable Damage Risk

    Stryker is recalling 61 FL23SE adjustable hospital beds because inserting an accessory into the head box slot can damage the nurse call system circuit.

    Product
    The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2269-2013·2013-10-02

    Smiths Medical Recalls Port-A-Cath Venous Access Systems Due to Sizing Issue

    Smiths Medical is voluntarily recalling Port-A-Cath and Port-A-Cath II implantable venous access systems and introducer sets because the introducer sheath opening may be too small for the catheter.

    Product
    Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable…
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2276-2013·2013-10-02

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling Monaco RTP System software versions 3.10.00 and later because an upgrade script may overwrite treatment couch files with incorrect default values.

    Product
    Monaco RTP System Radiation treatment planning
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2267-2013·2013-10-02

    Microgenics Recalls DRI Cocaine Metabolite Assay Due to Reagent Degradation

    Microgenics Corp is recalling specific lots of DRI Cocaine Metabolite Assay because surveillance showed unexpected reagent degradation. The recall affects 1,473 units distributed across multiple US states.

    Product
    DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the…
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2280-2013·2013-10-02

    Horiba Medical Recalls ABX PENTRA Calcium CP Reagent for Incorrect Results

    Horiba Medical is recalling ABX PENTRA Calcium CP Reagent because it may report incorrect calcium results on PENTRA 200 and 400 analyzers.

    Product
    ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2281-2013·2013-10-02

    CareFusion Recalls Gravity Sets Due to Incorrect Expiration Date Labeling

    CareFusion is recalling 2,850 units of Gravity Set Model 44000-07 because they are labeled with a 5-year expiration date instead of the correct 3-year date.

    Product
    CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2188-2013·2013-09-25

    B. Braun Outlook ES Infusion Pumps Recalled for Display Error

    B. Braun Medical Inc. is recalling Outlook ES pumps because the display may show infusion is active when the pump has actually stopped.

    Product
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2227-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.

    Product
    OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2013·2013-09-25

    GE Healthcare recalls READY View fMRI software due to incorrect maps

    GE Healthcare is recalling READY View software because it may compute and display incorrect fMRI activation maps.

    Product
    GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2200-2013·2013-09-25

    Medtronic Recalls T8 Removal Heads Due to Incorrect Hardness Specification

    Medtronic is recalling nine T8 Removal Heads used in spinal surgery due to incorrect hardness specifications that could cause the tool to fail during implant removal.

    Product
    T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B650 Due to Potential Issues

    GE Healthcare is recalling CARESCAPE Monitor B650 units due to potential issues. No injuries or illnesses have been reported.

    Product
    GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2013·2013-09-25

    Smith & Nephew Recalls OSTOSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTOSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 929 ACL TOP analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2251-2013·2013-09-25

    Churchill Medical Recalls Vygon 14 Microbore Extension Sets

    Churchill Medical Systems is recalling 13,100 Vygon 14 Microbore Extension Sets because the tubing may disconnect from the male luers.

    Product
    Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2013·2013-09-25

    Villa Radiology Juno DRF Mobile X-ray System Recalled for Display Errors

    Villa Radiology Systems LLC is recalling 22 Juno DRF mobile X-ray systems because displayed radiation dose values may be inaccurate by more than 35%.

    Product
    Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2234-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX ULTRA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide