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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9651–9675 of 27393

  • 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-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-1355-2022·2022-07-20

    MiniMed 670G Insulin Pump Battery Cap Defect Causing Power Loss

    MiniMed 670G Insulin Pump may lose power due to battery cap deterioration, affecting approximately 279,251 units distributed in the U.S. and overseas.

    Product
    MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1367-2022·2022-07-20

    Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions

    Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.

    Product
    Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
    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-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-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-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-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-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-1368-2022·2022-07-20

    Dental bonding primer may lack resin component affecting restoration

    Ultradent Peak Universal Bond self-etch dental primers may be missing resin, potentially compromising bond strength. Affected products were distributed nationwide and internationally.

    Product
    Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2022·2022-07-20

    Radiography System Firmware Error May Cause Incorrect Radiation Dose

    Philips DigitalDiagnost 4 radiography systems may deliver incorrect radiation doses due to a Wallstand VS2 firmware issue causing incorrect image orientation and misaligned anatomical markers.

    Product
    DigitalDiagnost 4 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-1325-2022·2022-07-20

    Philips ProxiDiagnost N90 radiography system: firmware issue causes incorrect radiation dose

    Philips is recalling 140 ProxiDiagnost N90 radiography systems due to a firmware issue in the Wallstand VS2 component. After system restart or first exposure with Wallstand VS2, the system may deliver incorrect radiation doses and misposition anatomic markers.

    Product
    ProxiDiagnost N90. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1354-2022·2022-07-20

    MiniMed 640G Insulin Pumps Recalled for Battery Cap Deterioration

    Medtronic has recalled approximately 323,417 MiniMed 640G insulin pumps due to battery cap deterioration that may cause loss of power and functionality. Patients should contact Medtronic or their healthcare provider immediately.

    Product
    MiniMed 640G Insulin Pump (O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 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-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-1383-2022·2022-07-20

    Aesculap Micro Needleholder Recalled for Incorrect Size Labeling

    Aesculap Implant Systems LLC is recalling TC Cooely Micro Needleholder instruments because units labeled as 200mm are actually 150mm. This labeling error could impact surgical procedures.

    Product
    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-1319-2022·2022-07-13

    Palindrome HSI Chronic Catheter Recalled for Potential Hub Leaking

    Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.

    Product
    Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1316-2022·2022-07-13

    Palindrome Chronic Catheter recalled due to potential hub leakage

    Covidien is recalling Palindrome Chronic Catheters due to a potential leaking condition in the hub that may cause unexpected fluid return during use.

    Product
    Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1276-2022·2022-07-13

    Clean Catch Urine Kit Recalled Due to Improper Assembly

    American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.

    Product
    Clean Catch Urine Kit NS 178489, AHMU58A
    Category
    Medical Device
    Distribution
    1 state