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.

23851–23875 of 50435

  • HighFDA (Devices)·Z-0975-2020·2020-02-12

    Cook Inc. Recalls Sof-Flex Double Pigtail Ureteral Stent Sets

    Cook Inc. is recalling Sof-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.

    Product
    Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0642-2020·2020-02-12

    Tres Coronas Bakery Recalls Flour Tortillas for Undeclared Wheat

    Tres Coronas Bakery is recalling Red Apple and Tres Coronas brand flour tortillas sold in Oregon due to undeclared wheat.

    Product
    Flour Tortillas are packaged in clear plastic bags, 12 count per bag and sold under brands Red Apple. Product is also sold under Tres Coronas brand and it has 10 counts per bag. The Red Apple brand label is read in parts: "***Flour Tortillas *** INGREDIENTS: FLOUR, WATER…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0592-2020·2020-02-12

    Munk Pack Coconut Cocoa Chip Keto Granola Bar Recalled for Undeclared Milk

    Munk Pack Inc. is recalling Coconut Cocoa Chip Keto Granola Bars because they may contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Munk Pack Coconut Cocoa Chip Keto Granola Bar, 4 pack, 128 g
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0974-2020·2020-02-12

    Cook Inc. Recalls Kwart Retro-Inject Ureteral Stent Sets

    Cook Inc. is recalling Kwart Retro-Inject Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2020·2020-02-12

    B. Braun Outlook Safety Infusion System Y-type Blood Set Recall for Leakage

    B. Braun Medical is recalling 1,824 Outlook Safety Infusion System Y-type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.

    Product
    Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.

    Product
    Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1064-2020·2020-02-12

    Centurion Medical Recalls Sterile Surgical Trays Due to Incomplete Seals

    Centurion Medical Products Corporation is recalling specific sterile surgical trays because incomplete seals may compromise sterility. The affected products were distributed nationwide and in Ghana.

    Product
    Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2020·2020-02-12

    B. Braun Recalls Y-Type Blood Sets Due to Leakage Risk

    B. Braun Medical is recalling 9,000 Y-Type Blood Sets because of a potential for leakage at the joint between the blood filters and tubing.

    Product
    Y-Type Blood Set, Catalog Number 490530
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2020·2020-02-12

    Centurion Incision and Drainage Trays Recalled for Incomplete Seals

    Centurion Medical Products is recalling specific Incision and Drainage Trays because incomplete seals may compromise sterility.

    Product
    Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 fabric-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2020·2020-02-12

    Cocoon Convective Warming System Recalled for Thermal Damage Risk

    Care Essentials is recalling 251 Cocoon Convective Warming Systems due to a potential for thermal damage near the power cord connector and Power Entry Module.

    Product
    Cocoon Convective Warming System, Product Code: CWS5000 (110V).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2020·2020-02-12

    Cook Inc. Recalls Urethral Dilator Sets Due to Wire Guide Loading Error

    Cook Inc. is recalling Urethral Dilator Sets because the wire guide may load incorrectly, causing a stiff tip to be introduced into the patient instead of a flexible one.

    Product
    Urethral Dilator Set, Global Product No. G14185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2020·2020-02-12

    Cocoon Convective Warming System Recalled for Thermal Damage Risk

    Care Essentials is recalling 689 Cocoon Convective Warming Systems due to a risk of thermal damage near the power cord connector and Power Entry Module.

    Product
    Cocoon Convective Warming System, Product Code: CWS4000 (110V).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0590-2020·2020-02-12

    Munk Pack Keto Dark Chocolate Bar Recalled for Undeclared Milk

    Munk Pack Inc. is recalling specific lots of Keto Nut and Seed Dark Chocolate Sea Salt Bars because they may contain undeclared milk.

    Product
    Munk Pack Keto Nut and Seed Dark Chocolate Sea Salt Bar, 35 g, individual unit
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1066-2020·2020-02-12

    Centurion Tracheostomy Care Kits Recalled Due to Incomplete Package Seals

    Centurion Medical Products is recalling specific tracheostomy care kits because incomplete seals on the sterile packaging may compromise sterility.

    Product
    Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2020·2020-02-12

    Cook Inc. Recalls Universa Firm Ureteral Stents Due to Loading Error

    Cook Inc. is recalling Universa Firm Ureteral Stents because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2020·2020-02-12

    Cook Inc. Recalls Heavy Duty PTFE Wire Guides Due to Loading Error

    Cook Inc. is recalling 146 Heavy Duty PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2020·2020-02-12

    Centurion Pelvic Exam Kits Recalled for Incomplete Sterile Seals

    Centurion Medical Products is recalling specific lots of Pelvic Exam Kits because incomplete seals may compromise sterility.

    Product
    Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2020·2020-02-12

    Centurion Medical Products Recalls Surgical Trays Due to Incomplete Seals

    Centurion Medical Products is recalling various surgical trays and kits because incomplete seals on the sterile packages may compromise sterility.

    Product
    Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2020·2020-02-12

    Centurion Medical Valve Change Kit Recalled for Incomplete Sterile Seals

    Centurion Medical Products Corporation is recalling Valve Change Kits due to incomplete sterile package seals that may compromise sterility.

    Product
    Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2020·2020-02-12

    Centurion Umbilical Vessel Catheter Recall Due to Incomplete Seals

    Centurion Medical Products is recalling Umbilical Vessel Catheter Insertion devices due to incomplete sterile package seals that may compromise sterility.

    Product
    Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0641-2020·2020-02-12

    Granuts BBQ Mix Recalled for Undeclared Wheat and Soy Allergens

    Compania Nacional de Chocolates DCR S.A. is recalling Granuts BBQ Mix in Puerto Rico due to undeclared wheat and soy allergens.

    Product
    Granuts BBQ Mix, Net Wt/Cont. Neto 16.93 oz (480g), Contains 12 units x 1.41 oz (40g) ea. and Net Wt/Cont. Neto 6.35 oz (180g)
    Category
    Food
    Distribution
    1 state