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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13726–13750 of 27471

  • HighFDA (Devices)·Z-2051-2020·2020-05-27

    Cardinal Health Recalls Strep B Carrot Broth Due to Temperature Abuse

    Cardinal Health is recalling Strep B Carrot Broth One-Step tubes because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2020·2020-05-20

    Philips Zenition 50 Medical Device Recalled for Electrical Contact Failure

    Philips is recalling 25 Zenition 50 devices because strain relief loss can cause electrical contacts to break, potentially exposing live parts or losing the video signal.

    Product
    Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1960-2020·2020-05-20

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Arm Faults

    Intuitive Surgical is recalling 74 da Vinci Xi Surgical Systems because a manufacturing variation can cause arm faults and loss of functionality during surgery.

    Product
    da Vinci Xi Surgical System
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1945-2020·2020-05-20

    Beckman Coulter iQ200 Urine Analyzer Recalled for Electrical Short Risk

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers due to a defect in the SATA power adapter cable that poses a risk of electrical short, charring, smoke, or flames.

    Product
    iQ200 Series Urine Microscopy Analyzer- All part numbers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1944-2020·2020-05-20

    Beckman Coulter iChem VELOCITY Urine Chemistry System Recalled for Fire Risk

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Systems due to a defect in the SATA power adapter cable that poses a risk of electrical short, smoke, or flames.

    Product
    iChem¿VELOCITY Urine Chemistry System-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1957-2020·2020-05-20

    Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling four Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1933-2020·2020-05-20

    Philips Zenition 70 Trolley Cable Recall for Electrical Contact Failure

    Philips is recalling 25 Zenition 70 systems because strain relief loss on the trolley cable can break electrical contacts, exposing live parts.

    Product
    Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1991-2020·2020-05-20

    FDA Recalls Dover Foley Catheters Due to Temperature Sensor Inaccuracy

    The FDA is recalling specific lots of Dover Foley catheters because their temperature sensors may not measure accurately. This could lead to incorrect patient diagnoses.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 7,395 saline flush syringes used in POWERWAND kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2020·2020-05-20

    Inpeco Abbott Accelerator a3600 Interface Module Recalled for Cross-Contamination Risk

    Inpeco S.A. is recalling 273 Abbott Accelerator a3600 Interface Modules because a timeout error could cause sample cross-contamination.

    Product
    Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2020·2020-05-20

    Encore Medical Recalls EMPOWR Acetabular Impactor Balls Due to Fracturing

    Encore Medical is recalling 86 units of EMPOWR Acetabular Impactor Balls because they may fracture during use, potentially leaving debris in the joint space.

    Product
    EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2020·2020-05-20

    Cardiac Assist Recalls 15 TandemHeart Pumps Due to Assembly Error

    Cardiac Assist, Inc. is recalling 15 TandemHeart pump kits due to an assembly error that may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2020·2020-05-20

    Argon Medical Devices Recalls PAC Tray Catheter Introducer Kits

    Argon Medical Devices is recalling 80 PAC Tray/5 Catheter Introducer Trays due to incorrect needle and suture components that may increase the risk of needle sticks.

    Product
    PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2020·2020-05-20

    CuattroDR System Software Recalled for Potential Image Misattribution

    Cuattro LLC is recalling CuattroDR System Software because images from previous patient studies may appear in later studies, potentially leading to misdiagnosis.

    Product
    CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1969-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leaking

    BD is recalling Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2020·2020-05-20

    Siemens Cios Spin Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 46 Cios Spin mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2020·2020-05-20

    Magstim Horizon PSU Stim Interconnecting Cable Recalled for Potential Failure

    The Magstim Company Limited is recalling 71 Horizon PSU Stim Interconnecting Cables because the high-voltage cable may fail. The device is used for treating Major Depressive Disorder.

    Product
    Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2020·2020-05-20

    Cardiac Assist Recalls 13 TandemLife Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 13 TandemLife Kits because an assembly error may prevent the pump from priming. The kits provide temporary circulatory support.

    Product
    TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 2,055 saline flush syringes because holes in the packaging compromised their sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2020·2020-05-20

    Dover Silicone Foley Catheter Recall for Temperature Sensor Inaccuracy

    FDA is recalling Dover silicone Foley catheters with temperature sensors that failed to meet calibration standards, posing a risk of incorrect patient diagnosis.

    Product
    Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1937-2020·2020-05-20

    Argon Medical Devices Recalls Arterial Line Kits Due to Needle Defect

    Argon Medical Devices is recalling Arterial Line Kits because they contain a thicker suture and curved needle that may increase the risk of needle sticks.

    Product
    Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects

    Access Scientific LLC is recalling 1,864 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1943-2020·2020-05-20

    Handicare Recalls EVA Floor Lifts Due to Potential Joint Failure

    Handicare AB is recalling 997 EVA Floor Lifts (Models 400, 450, 600) in the US and Mexico because abnormal use could cause the liftarm joint to break, posing an injury risk.

    Product
    EVA Floor Lifts, Model Numbers: 400, 450, 600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1936-2020·2020-05-20

    Argon Medical Devices Recalls Arterial Line Kits Due to Needle Defect

    Argon Medical Devices is recalling 150 Arterial Line Kits because they contain a thicker suture and curved needle that may increase the risk of needle sticks.

    Product
    Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label…
    Category
    Medical Device
    Distribution
    Distributed nationwide