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.

Filters

Agency

Category

Minimum severity

Clear filters

22476–22500 of 27663

  • HighFDA (Devices)·Z-0336-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 133 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0324-2016·2015-12-02

    Pega Medical Recalls SCFE Driver Instruments Due to Threaded Shaft Breakage

    Pega Medical Inc. is recalling 4 SCFE Driver instruments distributed in Florida and Tennessee because the threaded shaft broke during use.

    Product
    SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0320-2016·2015-12-02

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Software Issue

    Philips is recalling HeartStart MRx Monitor/Defibrillators because a software issue may cause the automated Ready-For-Use test to stop in an abnormal state when the device is turned off.

    Product
    Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 323 System One S Cycler units due to a software error that may cause inaccurate fluid removal during hemodialysis.

    Product
    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 10 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 2,134 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0338-2016·2015-12-02

    Masimo Recalls Rainbow Reusable Sensors Due to Inaccurate Readings

    Masimo is recalling Rainbow Reusable Sensors because incompatible configurations may cause no readings or inaccurate SpCO and SpMet results.

    Product
    rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2016·2015-12-02

    Siemens Dimension Vista Magnesium Reagent Cartridge Recall for Low Results

    Siemens Healthcare Diagnostics is recalling 3,601 Dimension Vista magnesium reagent cartridges due to erroneous low results that may affect patient and quality control testing.

    Product
    Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0274-2016·2015-11-25

    Hill-Rom Recalls 100 Low Bed Units Due to Patient Injury Reports

    Hill-Rom is voluntarily recalling 12,251 Hill-Rom 100 Low Beds because patients were injured while exiting the beds at the lowest position setting.

    Product
    Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0230-2016·2015-11-25

    Event Medical Recalls Inspiration Ventilators Due to Power Board Failure

    Event Medical is recalling Inspiration Ventilator Systems because a power board component can fail, causing the device to shut down without an alarm.

    Product
    Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0277-2016·2015-11-25

    Teleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk

    Teleflex Medical is recalling 2,050 Taut Intraducers 10/BX7.5 FR 3.5 devices because a defective component can cause gas leakage, potentially requiring device replacement.

    Product
    Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0284-2016·2015-11-25

    Prism Medical C-300 Ceiling Lifts Recalled for Drive Shaft Failure

    FDA is recalling 561 Prism Medical C-300 ceiling lifts because the drive shaft and over-speed arm may fail simultaneously, potentially causing a patient to fall.

    Product
    Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0295-2016·2015-11-25

    Fresenius 132 Gallon Dry Acid Dissolution Units Recalled for Fire Risk

    Fresenius Medical Care is recalling 348 dry acid dissolution units because defective motors may generate smoke or cause fire.

    Product
    Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0294-2016·2015-11-25

    Fresenius GranuFlo Dissolution Units Recalled for Fire Risk

    Fresenius Medical Care is recalling 918 GranuFlo Dissolution Units because they lack full thermal protection, which can generate smoke or lead to fire.

    Product
    Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0285-2016·2015-11-25

    Prism Medical P-300 Portable Consumer Lift Recalled for Drive Shaft Failure

    ErgoSafe Products is recalling 1,721 Prism Medical P-300 Portable Consumer Lifts because the drive shaft and over speed arm may fail, potentially causing a patient to fall.

    Product
    Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0296-2016·2015-11-25

    Fresenius Modified Mixer Motor Recalled Due to Fire Risk

    Fresenius Medical Care is recalling 992 Modified Mixer Motors for 132 Gallon Dissolution Units because they lack full thermal protection, posing a fire hazard.

    Product
    Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2016·2015-11-25

    Brainlab IGS System Recalled for Inaccurate Patient Anatomy Registration

    Brainlab AG is recalling 12 Image Guided Surgery systems in the US and Australia because data sets were not accurately registered to patient anatomy.

    Product
    BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0280-2016·2015-11-25

    Cyberonics Vagus Nerve Stimulator Recall for Sensing Delays

    Cyberonics is recalling 27 Model 106 Vagus Nerve Stimulator generators due to delays in heartbeat detection and potential decreased battery longevity.

    Product
    Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0310-2016·2015-11-25

    Ameditech Recalls Benzodiazepine Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling EDI BZO Uncut Sheet-Card drug abuse tests because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2016·2015-11-25

    Civco Needle Guide Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 508 boxes of Needle Guide Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2016·2015-11-25

    Ameditech Recalls DrugCheck Waived 12 Panel Cup Tests

    Ameditech is recalling DrugCheck Waived 12 Panel Cup tests because they have shown reduced reactivity.

    Product
    DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2016·2015-11-25

    Ameditech Recalls 11 Panel Dip Cards Due to Reduced Reactivity

    Ameditech is recalling 11 Panel Dip Cards (OPI 2000 and OPI 300) because they have shown reduced reactivity. The recall covers 150 units distributed in the US and Australia.

    Product
    11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2016·2015-11-25

    Civco PercuNav Tracking Bracket Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling PercuNav tracking bracket kits because the sterility of the product cannot be assured.

    Product
    CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2016·2015-11-25

    Synthes Sternal ZIPFIX Application Instrument Recall for Screw Failure Risk

    Synthes is recalling 267 previously repaired Sternal ZIPFIX Application Instruments because the screws may break or loosen.

    Product
    Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0313-2016·2015-11-25

    Ameditech Recalls Micro Screen 6 Panel Drug Abuse Test Cups

    Ameditech is recalling Micro Screen 6 Panel Cup drug abuse tests because they have shown reduced reactivity.

    Product
    Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide