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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11451–11475 of 13748

  • HighFDA (Devices)·Z-1365-2022·2022-07-20

    Neonatal Transport System Oxygen Supply Component Pressure-Rating Defect

    Draeger Medical is recalling neonatal transport systems because an oxygen supply component is not rated for the system's working pressure. This affects 38 units distributed internationally but not in the United States.

    Product
    Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1363-2022·2022-07-20

    PALMAZ GENESIS Transhepatic Biliary Stent Risk of Dislodgement

    Cordis is recalling 1,089 units of PALMAZ GENESIS Transhepatic Biliary Stents due to potential stent dislodgement in two specific device sizes. Affected patients should contact their healthcare provider.

    Product
    PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2022·2022-07-20

    Tibial Prosthesis Component Recalled for Intraoperative Screw Loosening Defect

    Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.

    Product
    Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1328-2022·2022-07-20

    Radiography system firmware bug may cause incorrect radiation doses

    Certain Philips DigitalDiagnost C90 X-ray systems contain a firmware defect that can cause incorrect radiation doses and misaligned anatomic position markers when using the Wallstand VS2 board.

    Product
    DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2022·2022-07-20

    Ivenix Infusion System Devices Recalled for Alarm Sequencing Defect

    The Ivenix Infusion System may malfunction where an occlusion alarm is immediately followed by a pump problem alarm, potentially delaying proper identification of the issue. FDA is recalling 1,335 affected devices.

    Product
    Ivenix Infusion System (IIS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2022·2022-07-20

    Radiography System Firmware Flaw May Cause Incorrect Image Orientation and Dose

    Philips DigitalDiagnost 4 Flex/Value radiography systems have a firmware issue in the Wallstand VS2 board that may cause incorrect image orientation and radiation dosing. The defect affects 140 systems distributed nationwide.

    Product
    DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2022·2022-07-20

    NATURALYTE Hemodialysis Dialysate Recalled Due to Unqualified Bottle Caps

    Fresenius Medical Care is recalling 656 cases of NATURALYTE Liquid Acid dialysate nationwide (lot 22CTAC106) because alternate bottle caps are not qualified for use, potentially compromising product integrity.

    Product
    NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1347-2022·2022-07-20

    CoolCore ZELTIQ Vacuum Applicator Voluntarily Recalled Due to Paradoxical Hyperplasia

    Zeltiq Aesthetics is voluntarily recalling CoolCore ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia, an adverse effect causing unwanted fat tissue growth. The recall affects 3,054 units distributed across the U.S. and internationally.

    Product
    CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1356-2022·2022-07-20

    MiniMed 720G Insulin Pump Recalled Due to Battery Cap Deterioration Risk

    Medtronic MiniMed is recalling approximately 575 MiniMed 720G Insulin Pumps due to battery cap deterioration that may result in power loss and device malfunction.

    Product
    MiniMed 720G Insulin Pump (O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1352-2022·2022-07-20

    MiniMed 620G insulin pump battery cap deterioration may cause power loss

    Medtronic MiniMed 620G insulin pumps may experience battery cap deterioration, resulting in incomplete battery circuit and loss of power. Approximately 2,287 affected pumps have been distributed across the U.S.

    Product
    MiniMed 620G Insulin Pump (O.U.S. version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1353-2022·2022-07-20

    MiniMed 630G Insulin Pump Recalled for Battery Cap Deterioration

    Medtronic MiniMed is recalling the MiniMed 630G insulin pump due to battery cap deterioration that may cause loss of power and function. Approximately 126,558 units distributed in the U.S. and Canada are affected.

    Product
    MiniMed 630G Insulin Pump (U.S. and Canada Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1377-2022·2022-07-20

    Modular Orthopedic Implant Screws May Not Loosen During Surgery

    FDA recalls certain Endo Model orthopedic implants because the blind screws may not loosen during surgery, potentially requiring surgeons to change their approach and prolonging the procedure.

    Product
    Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1371-2022·2022-07-20

    Hemodialysis Dialysate Recalled for Unqualified Bottle Caps

    Fresenius Medical Care is recalling NATURALYTE Liquid Acid dialysate because bottle caps are not qualified for use. The recall affects 163 cases of lot 22CTAC102 distributed nationwide.

    Product
    NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1360-2022·2022-07-20

    Isopure IsoMix PRO Mixing System Electrical Short Recall

    Isopure is recalling approximately 119 units of the Sodium Bicarbonate Mixing and Distribution System due to an electrical short causing a thermal event and device damage. No injuries reported.

    Product
    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1373-2022·2022-07-20

    Alcon Custom Pak Surgical Procedure Packs recalled for incorrect latex gloves

    Alcon has recalled 320 kits of Custom Pak Surgical Procedure Packs distributed across Arizona, California, Missouri, and New York because they contain latex gloves instead of the specified non-latex gloves, creating an allergen hazard for sensitive patients.

    Product
    Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1364-2022·2022-07-20

    AquaBplus Water Purification System installation guideline error reduces disinfection

    AquaBplus 2000 water purification systems for dialysis have an installation guideline error that may reduce heat disinfection effectiveness. Patients using affected units may be at risk.

    Product
    AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2022·2022-07-20

    Tibial Prosthetic Component Recall: Blind Screws Cannot Be Loosened Intraoperatively

    Tibial prosthetic components have defective blind screws that may not loosen during surgery, requiring procedure changes. Approximately 3,785 units of models W 16-2817/32, 35, and 37 were distributed across the US and internationally.

    Product
    Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1358-2022·2022-07-20

    MiniMed 770G Insulin Pump Battery Cap May Deteriorate, Causing Power Loss

    Medtronic is recalling MiniMed 770G insulin pumps because battery cap deterioration may cause power loss and insulin delivery failure. Approximately 123,585 units are affected.

    Product
    MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1372-2022·2022-07-20

    Blood gas test device recalled for inaccurate oxygen measurements

    Siemens epoc BGEM Test Cards may produce inaccurate blood oxygen measurements, potentially leading to misdiagnosis and unnecessary respiratory treatment. The recall affects 263 boxes distributed across multiple states.

    Product
    epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1385-2022·2022-07-20

    HAMILTON-H900 Humidifier Recall Due to Delayed Low-Water Alarm

    Hamilton Medical's HAMILTON-H900 humidifier (models 950001, 950004) is recalled due to delayed low-water level alarms that may prevent medical staff from detecting an empty chamber during mechanical ventilation use.

    Product
    HAMILTON-H900 Humidifier, Models: 950001, 950004
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1384-2022·2022-07-20

    Anti-FITC-AP CISH Kit Label Bears Incorrect Expiration Date

    Agilent Technologies is recalling 63 Anti-FITC-AP CISH Accessory Kits due to incorrect expiration dates on substrate vial labels, which may result in the use of expired materials.

    Product
    Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1351-2022·2022-07-20

    Philips LAS-100 Laser System may not operate due to detected hardware failure

    Spectranetics' Philips LAS-100 Laser System (105 units) may fail to start if the device detects an inoperable hardware component during power-up, requiring manual error code clearing before operation.

    Product
    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1375-2022·2022-07-20

    Cathcart Hip Ball prosthesis recalled for missing surgical technique specification

    DePuy Orthopaedics is recalling Modular Cathcart Hip Ball prostheses (sizes 41-60mm) because the Instructions for Use and Surgical Technique Guide did not document a +5mm offset specification. Updated guides now clarify this for hemi-hip arthroplasty procedures.

    Product
    MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000
    Category
    Medical Device
    Distribution
    Distributed nationwide