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 deaths or serious injuries are reported, 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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

3901–3925 of 5038

  • SevereFDA (Devices)·Z-2213-2016·2016-07-27

    AMD-RITMED Conforming Stretch Gauze Bandages Recalled for Sterility Failure

    AMD-RITMED is recalling specific lots of sterile conforming stretch gauze bandages because FDA testing showed they did not meet sterility requirements.

    Product
    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawa
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-1887-2016·2016-07-20

    Heartware Ventricular Assist System Battery Recall for Premature Depletion

    Heartware, Inc. is recalling 18,631 HeartWare Ventricular Assist System batteries due to premature depletion. The recall covers devices distributed nationwide in the US.

    Product
    HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricul
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2139-2016·2016-07-20

    Hospira Recalls LifeCare PCA Plus II Infusion Pumps Due to Occlusion Detection Failure

    Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.

    Product
    The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2146-2016·2016-07-20

    Hardy Diagnostics Recalls QuickSlide MGS-80 Gram Stainers Due to Discrepant Results

    Hardy Diagnostics is recalling 25 QuickSlide MGS-80 and GramPRO-80 automated Gram stainers because they may produce discrepant culture and Gram stain results, potentially leading to misdiagnosis or improper patient treatment.

    Product
    QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-2141-2016·2016-07-20

    Hospira Recalls LifeCare PCA Infusion Systems Due to Occlusion Detection Failure

    Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.

    Product
    LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2142-2016·2016-07-20

    Hospira LifeCare Pump Model 4200 PCA Infuser Recalled for Occlusion Detection Failure

    Hospira is recalling 6,268 LifeCare Pump Model 4200 PCA Infusers because they may fail to detect distal occlusions, a defect that caused one serious injury.

    Product
    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2140-2016·2016-07-20

    Hospira PCA 3 Infusion Pump Recall for Occlusion Detection Failure

    Hospira is recalling 8,216 PCA 3 infusion pumps because normal wear on a component may prevent the device from detecting distal occlusions, a defect that resulted in one serious injury.

    Product
    The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2122-2016·2016-07-13

    Medtronic Recalls Cytosponge Cell Collection Kits Due to Detachment Reports

    Medtronic is recalling Cytosponge Cell Collection Kits after two reports of the device detaching from the removal string during withdrawal from the esophagus.

    Product
    Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophag
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2060-2016·2016-07-06

    Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage

    Hospira is recalling PlumSet IV administration sets because intravenous fluid may leak at the secondary port. The recall covers 3,920,932 units distributed in the US and Canada.

    Product
    *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2100-2016·2016-07-06

    Physio-Control Recalls LIFEPAK AEDs Due to Shock Delivery Failure Risk

    Physio-Control is recalling LIFEPAK CR Plus and EXPRESS AEDs because a faulty component may prevent the device from delivering a shock during cardiac arrest.

    Product
    LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2114-2016·2016-07-06

    Philips Ingenuity Core 128 MRI Systems Recalled for Cover Crack Risk

    Philips is recalling 14 Ingenuity Core 128 MRI systems because a thinner plastic cover may crack, posing an injury risk to patients and staff.

    Product
    Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2113-2016·2016-07-06

    Philips Ingenuity Flex MRI Units Recalled for Cracking Cover Hazard

    Philips is recalling 10 Ingenuity Flex MRI units because a thinner plastic cover may crack, posing an injury risk to patients and staff.

    Product
    Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1891-2016·2016-06-22

    CareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1894-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Ventilators because a defective fuse on the TCA Board may fail, causing loss of power to the User Interface Module.

    Product
    TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1892-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1898-2016·2016-06-22

    CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

    CareFusion is recalling AVEA Ventilator upgrade kits because an incorrect fuse may fail, causing loss of power to the User Interface Module.

    Product
    AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1978-2016·2016-06-22

    Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1916-2016·2016-06-15

    Hill-Rom Recalls Liko Universal SlingBars Due to Center Bolt Failure Risk

    Hill-Rom is recalling Liko Universal SlingBars because the center bolt may weaken and break, posing a risk of patient falls and injury.

    Product
    Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1856-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1847-2016·2016-06-08

    Curity Gauze Sponges Recalled for Compromised Sterility

    Covidien LLC is recalling Curity Gauze Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1852-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1857-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a breach of the barrier.

    Product
    Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556
    Category
    Medical Device
    Distribution
    Distributed nationwide