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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11676–11700 of 27470

  • HighFDA (Devices)·Z-1672-2021·2021-06-02

    Welch Allyn GS777 Wall Transformer Recalled for Electrical Shock Risk

    Welch Allyn is recalling GS777 Wall Transformers due to a potential risk of fluid ingress causing electrical shorts and shock.

    Product
    GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1670-2021·2021-06-02

    Beckman Coulter Access SARS-CoV-2 Antigen Recalled for False Negative Risk

    Beckman Coulter is recalling Access SARS-CoV-2 Antigen test kits because specimens stored in certain conditions may yield false negative results.

    Product
    Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2021·2021-06-02

    Pentax Medical Video Duodenoscope Recalled for Distal End Cap Detachment Risk

    Pentax of America Inc. is recalling 108 Pentax Medical Video Duodenoscopes because the distal end cap may detach during procedures, posing risks of injury or aspiration.

    Product
    Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2021·2021-06-02

    Welch Allyn ProBP 3400 Digital Blood Pressure Device Recall

    Welch Allyn is recalling ProBP 3400 Digital Blood Pressure Devices due to a risk of fluid ingress causing electrical shorts and potential shock.

    Product
    ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2021·2021-06-02

    Baxter Gambro Cartridge Blood Set Recalled for Potential Leak Risk

    Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential leak between the venous patient connector and the patient's hemodialysis access.

    Product
    Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1687-2021·2021-06-02

    James Leckey MyWay Walker Chassis Recalled Due to Weld Failure

    James Leckey Design Ltd is recalling 2,719 MyWay Walker Chassis units because weld failures caused casters to detach from the rear legs.

    Product
    MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2021·2021-06-02

    Dentech Corp. Recalls Rubber Dam Clamps Due to Possible Breakage

    Dentech Corp. is recalling 87,842 units of KSK Rubber Dam Clamps because they may break during use. The recall covers units distributed in the US and worldwide.

    Product
    Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2021·2021-06-02

    Philips IntelliVue MX40 Patient Monitor Recalled for Manufacturing Defects

    Philips is recalling three IntelliVue MX40 patient monitors because manufacturing process failures may have resulted in defective devices.

    Product
    IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2021·2021-05-26

    Biopsybell 11G Direct Single Delivery Kits Recalled for Sterility Concerns

    Biopsybell is recalling 160 units of 11G Direct Single Delivery kits because they were labeled as sterile but may not have been sterilized.

    Product
    11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1623-2021·2021-05-26

    Bioseal Chest Tube Insertion Tray Recalled for Mold Contamination

    Bioseal Corporation is recalling 140 units of Chest Tube Insertion Trays because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1644-2021·2021-05-26

    Biopsybell 11G Direct Single Access Devices Recalled for Sterility Concerns

    Biopsybell is recalling 50 units of 11G Direct Single Access devices labeled as sterile but potentially not sterilized, distributed in Mississippi and Kentucky.

    Product
    11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2021·2021-05-26

    Biopsybell 10 Gauge Direct Unilateral Stylets Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets because they were labeled as sterile but may not have been sterilized.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2021·2021-05-26

    Biopsybell 11G Direct Working Cannula Recalled for Sterility Concerns

    Biopsybell is recalling 75 units of 11G Direct Working Cannula Diamond Tip Mini because they were labeled sterile but may not have been sterilized.

    Product
    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2021·2021-05-26

    BPB medica CEMIX Cement Mixing System Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system because products labeled as sterile may not have been sterilized.

    Product
    BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1640-2021·2021-05-26

    Biopsybell 8G Direct Working Cannula Bevel Tip Recall for Sterility Concerns

    Biopsybell is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile that may not have been sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1592-2021·2021-05-26

    Boston Scientific Recalls VICI RDS Venous Stent System Due to Migration

    Boston Scientific is recalling VICI RDS Venous Stent Systems manufactured between May 2018 and April 2021 due to reports of stent migration after implantation.

    Product
    VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1635-2021·2021-05-26

    Biopsybell Cement Mixing System Recalled for Potential Sterility Failure

    Biopsybell S.R.L. is recalling 500 units of the Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref VCF-1051, because products labeled as sterile may not have been sterilized.

    Product
    CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1633-2021·2021-05-26

    BPB medica Kyphoplasty Cannula Recalled for Potential Sterility Failure

    BPB medica is recalling 10 units of RENOVA SPINE kyphoplasty cannulas labeled as sterile but potentially not sterilized. The recall covers distribution in Mississippi and Kentucky.

    Product
    BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate glucose readings.

    Product
    Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3 5PK 9L OUS1/ GTIN: 20763000243320 GS3 5PK 9L OUS1/ GTIN: 20763000318844 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1656-2021·2021-05-26

    Bard Access Systems Recalls Groshong NXT ClearVue Catheters Due to Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference

    Medtronic is recalling Guardian Sensor 3 kits because use with the drug hydroxyurea may cause inaccurate, elevated glucose readings.

    Product
    Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously…
    Category
    Medical Device
    Distribution
    0 states