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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11701–11725 of 27470

  • HighFDA (Devices)·Z-1598-2021·2021-05-26

    RayStation software recall due to incorrect total dose display

    RaySearch Laboratories is recalling RayStation software because the total dose display may be incorrect when using multiple plans in a treatment course.

    Product
    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1634-2021·2021-05-26

    BPB medica Osteobell Explant Needle Recalled for Sterility Concerns

    BPB medica is recalling Osteobell Explant Needles because they were labeled as sterile but may not have been sterilized.

    Product
    BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for 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 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1658-2021·2021-05-26

    Bard Access Systems Recalls Replacement Connectors for Groshong NXT PICC Catheters

    Bard Access Systems is recalling specific replacement connectors for Groshong NXT PICC catheters due to manufacturing defects that may prevent proper catheter passage or locking.

    Product
    REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1668-2021·2021-05-26

    Bard Access Systems Recalls Groshong NXT ClearVue Catheter Kits

    Bard Access Systems is recalling specific Groshong NXT ClearVue Catheter Basic Kits because the distal connector may be defective, preventing proper catheter passage or locking.

    Product
    REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1665-2021·2021-05-26

    Bard Groshong Catheter Recall for Connector and Locking Defects

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

    Product
    REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

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

    Product
    REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2021·2021-05-26

    Biopsybell Recalls Sterile Spine Bone Filler Due to Sterilization Concerns

    Biopsybell S.R.L. is recalling 60 units of Renova Spine Bone Filler labeled as sterile but potentially not sterilized. The product was distributed in Mississippi and Kentucky.

    Product
    RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2021·2021-05-26

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

    Biopsybell S.R.L. is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile but potentially not sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1615-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

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

    Product
    Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1617-2021·2021-05-26

    Medtronic Enlite Glucose Sensor Recalled for Inaccurate Readings

    Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea may cause inaccurate elevated readings.

    Product
    Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1662-2021·2021-05-26

    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 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036016 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2021·2021-05-26

    Medtronic Enlite Glucose Sensor Recall Due to Hydroxyurea Interference

    Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea may cause inaccurate elevated readings.

    Product
    Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1605-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea

    Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea can cause inaccurate elevated glucose readings.

    Product
    Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1664-2021·2021-05-26

    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 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741147521 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall 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 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2021·2021-05-26

    Bard Groshong Catheter Recall for Connector Defects

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

    Product
    REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2021·2021-05-26

    Roche Recalls Troponin I Immunoassay Kits Due to False Negative Risk

    Roche Diagnostics is recalling 726 Elecsys Troponin I Immunoassay kits because they may produce false negative results when run immediately after proBNP II tests on specific modules.

    Product
    Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1611-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings

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

    Product
    Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1601-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea

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

    Product
    Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1669-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

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

    Product
    REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1612-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

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

    Product
    Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1646-2021·2021-05-26

    Biopsybell Cement Delivery Kits Recalled for Potential Sterility Failure

    Biopsybell is recalling 305 units of 10 Gauge Single Cement Delivery kits because they were labeled sterile but may not have been sterilized.

    Product
    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference

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

    Product
    Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1666-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

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

    Product
    REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide