The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

20351–20375 of 50413

  • 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
  • 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 (Food)·F-0496-2021·2021-05-26

    White Oak Pear Gorgonzola Salad Dressing Recalled for Undeclared Sulfites

    Global Palate Foods is recalling White Oak Farm & Table Pear Gorgonzola Salad Dressing because the product contains undeclared sulfites from Dijon mustard and red wine vinegar.

    Product
    White Oak Farm & Table brand Pear Gorgonzola Salad Dressing & Dipping Sauce; 12 Fl OZ, packaged in glass bottles
    Category
    Food
    Distribution
    3 states
  • 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
  • HighNHTSA·21V393000·2021-05-26

    Grand Design RV Travel Trailers LP Regulator Fire Risk Recall

    Grand Design is recalling 55,508 travel trailers (2016-2021 Imagine, Transcend, Momentum) for defective LP regulators that may cause excessive gas pressure and increase fire risk. Free replacement available through dealers.

    Product
    GRAND DESIGN — GRAND DESIGN IMAGINE, MOMENTUM, TRANSCEND
    Category
    Vehicle
    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
  • HighNHTSA·21V391000·2021-05-26

    Heavy-duty trucks recalled for fuel rail defect and fire risk

    PACCAR is recalling certain 2018-2021 Kenworth and Peterbilt commercial trucks because a sealing washer defect in the fuel rail assembly may cause fuel leaks. When fuel leaks occur near an ignition source, fire risk increases.

    Product
    PETERBILT — PETERBILT, KENWORTH 367, 337, 567, T370
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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 (Food)·F-0492-2021·2021-05-26

    Desserts On Us Baklava Recalled for Undeclared Milk Allergen

    Desserts On Us, Inc. is recalling 264 units of Original Traditional Baklava because the label failed to declare milk, a major allergen.

    Product
    Desserts On Us Original Traditional Baklava: Net Wt. 4 oz., (113g) UPC: 7 59098 51001 3 Desserts On Us, 57 Belle Falor Court, Arcata, CA 95521 Ingredients: Almonds, Sugar, filo dough [wheat flour(enriched with niacin, iron, thiamine mononitrate, riboflavin, folic…
    Category
    Food
    Distribution
    2 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 (Food)·F-0542-2021·2021-05-26

    Bloommy Biotin Collagen Keratin Capsules Recalled for Undeclared Fish

    Bloommy Inc. is recalling Biotin Collagen Keratin Capsules because they contain undeclared fish collagen, a potential allergen.

    Product
    "Bloomy*** Biotin Collagen Keratin***Capsules for SKIN, JOINT, HAIR***Supplement Facts***Marine Collagen***Manufactured for Bloommy Inc. 106 W. Broad St. Pawcatuck, CT 06379"
    Category
    Food
    Distribution
    Distributed nationwide