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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26601–26625 of 27722

  • HighFDA (Devices)·Z-1267-2013·2013-05-15

    Symmetry Medical Recalls Collins Radioparent Sternal Blades Due to Breakage Risk

    Symmetry Medical is recalling Collins Radioparent Sternal Blades because they may break during use. The recall covers 524 boxes distributed worldwide.

    Product
    Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1242-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Two Stage Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Ultra Embryo Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2013·2013-05-15

    Olympus UES-40 Electrosurgical Unit Recalled for Overheating and Smoke

    Olympus America Inc. is recalling 608 UES-40 electrosurgical units due to overheating, smoke vapors, and operational failures.

    Product
    Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2013·2013-05-15

    Cypress Medical Recalls MediChoice Umbilical Cord Clamps Due to Breakage

    Cypress Medical Products LLC is voluntarily recalling one lot of MediChoice Umbilical Cord Clamps because they are breaking upon use.

    Product
    Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1268-2013·2013-05-15

    Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

    Baxter Healthcare is recalling specific lots of Non-DEHP catheter extension sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1170-2013·2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Unexpected Shutdowns

    Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning, potentially interrupting patient medication delivery.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1189-2013·2013-05-08

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Therapy Failure Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver defibrillation therapy in Manual Defib or AED mode.

    Product
    HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1191-2013·2013-05-08

    Medtronic Recalls DBS Therapy Kits Due to Potential Lead Damage

    Medtronic is recalling DBS Therapy for Dystonia Kits because the provided lead cap may damage the lead connector, potentially compromising the device.

    Product
    Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1169-2013·2013-05-08

    Hospira GemStar Infusion Pumps Recalled for Unintended Shutdowns

    Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning. The recall affects pumps distributed worldwide.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1159-2013·2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss

    Hospira Inc. is recalling GemStar infusion pumps because low battery levels can corrupt history logs and cause an error that prevents the device from being used.

    Product
    GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1177-2013·2013-05-08

    Maquet SERVO-i Ventilator Battery Modules Recalled for Shorter Run Time

    Maquet is recalling SERVO-i ventilator battery modules because some units have shorter battery run times than expected.

    Product
    Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1190-2013·2013-05-08

    Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Damage Risk

    Medtronic is recalling 30,000 Deep Brain Stimulation lead kits worldwide because the provided lead cap may damage the lead connector during use.

    Product
    Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1185-2013·2013-05-08

    Medi-Trace Pediatric Defibrillation Electrodes Recalled for Arcing Risk

    FDA is recalling Medi-Trace Cadence Pediatric Defibrillation Electrodes because arcing or sparking may damage the leadwire, preventing the device from delivering appropriate energy to patients.

    Product
    Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1160-2013·2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss

    Hospira is recalling GemStar infusion pumps because low battery levels can corrupt data and cause an error that prevents the device from being used.

    Product
    GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1171-2013·2013-05-08

    Newport Medical Instruments Recalls HT70 Ventilator Power Pac Batteries

    Newport Medical Instruments is voluntarily recalling HT70 and HT70 Plus ventilator Power Pac batteries because they may cause the ventilator to alarm and switch to backup power sooner than expected.

    Product
    Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of…
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1183-2013·2013-05-08

    B. Braun Recalls Diacap Ultra Dialysis Fluid Filters Due to Moisture Loss

    B. Braun Medical is recalling 1,580 Diacap Ultra Dialysis Fluid Filters because residual moisture may reduce over time, lowering membrane permeability.

    Product
    Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2013·2013-05-08

    Stryker AxSOS Drill Bit Recalled Due to Incorrect Scale

    Stryker Orthopaedics is recalling AxSOS Calibrated Drill Bits because an incorrect scale may cause surgeons to select screws that are 10mm longer than intended.

    Product
    Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1000-2013·2013-05-08

    Trophy CareStream Dental CS 2200 X-ray System Recall for Bent Connector

    Trophy Sas is recalling CareStream Dental CS 2200 X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2013·2013-05-08

    GE Healthcare Recalls CT Scanners Due to Heat Exchanger Bolt Defect

    GE Healthcare is recalling 166 CT scanners because improperly torqued heat exchanger bolts may cause parts to detach and spill oil.

    Product
    GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2013·2013-05-08

    Siemens Medical Solutions Recalls RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling RT Therapist software versions 4.2.108 to fix multiple safety-related issues on linear accelerator systems.

    Product
    Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2013·2013-05-08

    Vital Images Recalls Vitrea CT Brain Perfusion Software Due to User Confusion

    Vital Images is recalling Vitrea CT Brain Perfusion software versions 6.0 and above due to potential user confusion when viewing scans from wide coverage shuttle acquisition techniques.

    Product
    Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1192-2013·2013-05-08

    Owens & Minor Recalls MediChoice OB/GYN Applicators Due to Rayon Defect

    Owens & Minor is withdrawing MediChoice OB/GYN applicators because the rayon tip may loosen or unravel during use.

    Product
    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2013·2013-05-08

    Medi-Trace Cadence Adult Defibrillation Electrodes Recalled for Thermal Damage Risk

    FDA is recalling Medi-Trace Cadence Adult Defibrillation Electrodes because arcing or sparking may cause thermal damage to the leadwire, potentially preventing the device from delivering appropriate energy to patients.

    Product
    Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1168-2013·2013-05-01

    GE Healthcare Recalls Ventri Discovery NM 530c Nuclear Imaging Systems

    GE Healthcare is recalling 556 Ventri Discovery NM 530c nuclear imaging systems because a moving table mechanism can pinch patient fingers during an exam.

    Product
    Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
    Category
    Medical Device
    Distribution
    40 states