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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10851–10875 of 27441

  • HighFDA (Devices)·Z-0066-2022·2021-10-13

    Zoll SOLEX 7(Heparin) IVTM Kit Recall: Potential Catheter and Tubing Leaks

    ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.

    Product
    Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2022·2021-10-13

    Medtronic Insertion Kits Recalled for Incorrect Guidewire Label Mix-Up

    Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.

    Product
    Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2022·2021-10-13

    Zoll ICY IV Disposable Pack Recall: Potential Catheter and Tubing Leaks

    ZOLL Circulation recalls the ICY IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 42 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0053-2022·2021-10-13

    ZOLL QUATTRO Intravascular Catheter Kit Labeling Update for Potential Leaks

    ZOLL Circulation is updating labeling for its QUATTRO Intravascular Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The update affects 1,733 units distributed worldwide.

    Product
    Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2022·2021-10-13

    ZOLL ICY Intravascular Catheter Kit Recalled for Potential Catheter and Tubing Leaks

    ZOLL Circulation is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The recall affects 58 kits distributed worldwide.

    Product
    Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2022·2021-10-13

    Cardiosave IABP helium indicator may show inaccurate readings during electromagnetic interference

    Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit when electromagnetic interference is present.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2022·2021-10-13

    Philips Ultrasound Sparq System Recalled Due to Intermittent Shutdown Risk

    Philips Ultrasound recalls the Sparq diagnostic ultrasound system due to a battery system data issue causing intermittent device shutdowns, regardless of actual battery status or AC power connection. Affected units were distributed in 10 US states and internationally.

    Product
    Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2582-2021·2021-10-06

    Ultrasound Gel Products Recalled for Possible Bacterial Contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The FDA recommends healthcare providers stop using these products immediately.

    Product
    Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2592-2021·2021-10-06

    Atrium Pneumostat Chest Drain Valve Recalled Following Fatal Preterm Infant Case

    Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.

    Product
    Atrium Pneumostat Chest Drain Valve, Part Number 16100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2577-2021·2021-10-06

    Reperfusion Catheter Recalled Due to Risk of Distal End Fracture

    Imperative Care ZOOM 71 Reperfusion Catheters are recalled due to potential for distal end fracture and detachment. This FDA Class I recall affects units distributed nationwide.

    Product
    Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2587-2021·2021-10-06

    GENOSYL DS vasodilator console recalled for reversed gas lines defect

    Vero Biotech recalled 3 GENOSYL DS consoles for a manufacturing defect that reverses gas inlet and outlet lines, causing delivery of toxic nitrogen dioxide instead of therapeutic nitric oxide.

    Product
    GENOSYL DS (Delivery System) console, for use as a vasodilator.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2583-2021·2021-10-06

    Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination Risk

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA issued a Class I recall on August 18, 2021.

    Product
    EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2518-2021·2021-10-06

    FDA Recalls Ultrasound Gels for Bacterial Contamination Risk

    Omnisound Gel and EcoGel 200 ultrasound gels distributed nationwide from January 2018 to August 2021 may contain bacterial contamination. The FDA issued a Class I recall; health care providers should immediately stop using these products.

    Product
    Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2499-2021·2021-10-06

    DeRoyal Procedure Packs with NORMOFLO Warming Sets Recalled for Aluminum Leaching

    DeRoyal procedure packs containing Smiths Medical NORMOFLO warming systems are recalled due to potential aluminum ion leaching into warming fluids. The FDA classified this Class I recall affecting 2880 units distributed in Florida and South Carolina.

    Product
    DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2601-2021·2021-10-06

    Patient lift devices may lose ability to maintain horizontal positioning during transfers

    Hill-Rom LikoStretch Mod 600 IC patient lift devices may fail to maintain patients in a horizontal position while lifting, potentially causing patients to slide or fall.

    Product
    LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2021·2021-10-06

    Operating room table rotational lock may fail to maintain position

    The rotational lock on certain operating room tables may fail to secure the table position. This could cause the table to move unexpectedly during diagnostic or surgical procedures.

    Product
    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2021·2021-10-06

    Patient lift device may lose horizontal positioning control, creating fall risk

    The OctoStretch with Stretch Leveller may lose its ability to keep patients horizontal during lifting, risking patient falls. 440 units were distributed worldwide.

    Product
    OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2021·2021-10-06

    Fluid management system control unit display freeze during hysteroscopic procedures

    A software defect in the Covidien HysteroLux fluid management system causes the display to freeze at a specific volume threshold during hysteroscopic surgery, creating risk of improper fluid accounting and potential circulatory complications.

    Product
    Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2021·2021-10-06

    Corin TriFit TS Orthopedic Implant Recall Due to Packaging Damage and Sterility Loss

    Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US states.

    Product
    Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2579-2021·2021-10-06

    PAS-PORT Proximal Anastomosis Device recalled for deployment failure risk

    Aesculap Implant Systems is recalling the PAS-PORT Proximal Anastomosis Device because the implant may fail to deploy successfully, potentially requiring additional medical intervention during surgery.

    Product
    PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2021·2021-10-06

    Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery

    B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.

    Product
    Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2543-2021·2021-10-06

    Carotid and Gelsoft vascular patches recalled for incorrect instructions

    Vascutek vascular patches were distributed with rest-of-world instructions instead of U.S. instructions. The 159 units distributed to Puerto Rico and Guam have incorrect Instructions for Use for U.S. use.

    Product
    The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2596-2021·2021-10-06

    GE Healthcare anesthesia machine flow sensors may over-deliver anesthetic

    Flow sensors in GE Healthcare anesthesia machines built before June 2021 may have damaged tubing that leaks, potentially causing over-delivery of anesthetic to patients.

    Product
    Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2549-2021·2021-10-06

    Outlook Pump Measured Volume Solution Set recalled for cassette leakage

    B. Braun is recalling 940 units of Outlook Pump Measured Volume Solution Sets due to potential leakage in the cassette. The leakage could delay medication delivery, result in incomplete dosing, or lead to bloodstream infections.

    Product
    Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2589-2021·2021-10-06

    Atrium ADVANTA VXT Vascular Graft may lack required radial support ring

    Atrium Medical Corporation is recalling 28 units of the Atrium ADVANTA VXT Vascular Graft because some packages may contain mismatched units lacking the radial support ring specified in labeling.

    Product
    Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide