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.

29351–29375 of 50499

  • HighFDA (Devices)·Z-1349-2018·2018-04-18

    Getinge Recalls VOLISTA StandOP Surgical Lights Due to Handle Detachment Risk

    Getinge is recalling 5,214 VOLISTA StandOP surgical lights because the central handle holder can detach, potentially dropping particles into the sterile field during procedures.

    Product
    VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2018·2018-04-18

    Arrow International Recalls Certain Lots of AGB+ Multi-Lumen CVC Kits

    Arrow International is recalling specific lots of AGB+ central venous catheter kits because the seals may be incomplete, preventing a guarantee of sterility.

    Product
    AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1373-2018·2018-04-18

    TriMed Inc. Recalls Hex Drivers Due to Epoxy Color Band Migration

    TriMed Inc. is recalling 1,525 hex drivers because the epoxy color band may migrate down the shaft or onto sterilization trays after sterilization.

    Product
    Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1355-2018·2018-04-18

    Bard Infant Feeding Tube Recalled for Ineffective Connector Fusion

    C.R. Bard is recalling 23,400 infant feeding tubes because the tubing and connector may not be effectively fused.

    Product
    Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2018·2018-04-18

    Beckman Coulter AQUIOS CL Flow Cytometer System Recalled for Sample ID Errors

    Beckman Coulter is recalling 288 AQUIOS CL Flow Cytometer Systems because the single tube loader may process the same sample with two different IDs, potentially causing erroneous results.

    Product
    AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2018·2018-04-18

    Arrow International Recalls Certain Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits because they may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side…
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·18142·2018-04-18

    Primark Recalls Decorative Cushions Due to Fire Hazard

    Primark is recalling about 14,500 decorative cushions sold in the northeastern U.S. because they can catch fire if exposed to an ignition source.

    Product
    Decorative cushions
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2018·2018-04-18

    Hill-Rom Progressa Bed Recall Due to Brake Component Failure Risk

    Hill-Rom is recalling 2,117 Progressa adjustable hospital beds because a braking system component may break, causing unwanted bed movement and potential injury.

    Product
    Progressa Bed - AC-powered adjustable hospital bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1008-2018·2018-04-18

    All American Seasonings Recalls Lost Cajun Gumbo Base Due to Salmonella

    All American Seasonings is recalling Lost Cajun Gumbo Base because an ingredient was contaminated with Salmonella. The recall involves 23 bags distributed to one customer in Colorado.

    Product
    LOST CAJUN GUMBO BASE, T4014, PACK SIZE 45 lb bag, Blended by ALL AMERICAN SEASONINGS, 10600 E. 54th Ave., Units B & C, Denver, CO 80239
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1334-2018·2018-04-18

    Arrow International Recalls Arrowg+ard Blue PSI Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of Arrowg+ard Blue PSI Kits because the catheters may not be completely sealed, preventing a guarantee of sterility.

    Product
    Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1364-2018·2018-04-18

    Orthofix Recalls Connector System Set Screws Due to Size Discrepancies

    Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may cause the driver to wedge or strip the screw.

    Product
    ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V246000·2018-04-18

    Riverside Recalls 2015-2017 Motorhomes Due to Fire Extinguisher Defects

    Riverside RV is recalling 2015-2017 White Water, Water Fall, and Mt. McKinley motorhomes because certain fire extinguishers may clog or detach, posing injury risks.

    Product
    RIVERSIDE — RIVERSIDE WATER FALL, MT. MCKINLEY, WHITEWATER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1357-2018·2018-04-18

    Bard Premature Infant Feeding Tubes Recalled for Ineffective Fusion

    C.R. Bard is recalling specific lots of Bard Premature Infant Feeding Tubes because the tubing and ENFit connector may not be effectively fused.

    Product
    Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2018·2018-04-18

    Arrow International Recalls Certain Central Venous Catheterization Kits

    Arrow International is recalling specific lots of central venous and vessel catheterization kits because the seals may be incomplete, potentially compromising sterility.

    Product
    (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1007-2018·2018-04-18

    Taylor Shellfish Recalls Original Smoked Oysters Due to Packaging Error

    Taylor Shellfish Co is recalling Original Smoked Oysters in vacuum pouches because the packaging method is incorrect for this product type, posing a potential botulism risk if not kept cold.

    Product
    Original Smoked Oysters, packaged in vacuum pouches, net wt. 2.25 oz. or 16 oz.. UPC 47094 20002
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1327-2018·2018-04-18

    Arrow PICC Kit Recall Due to Potential Sterility Seal Failure

    Arrow International is recalling specific lots of ARROW PICC Kits because the seals may not be completely closed, meaning the product's sterility cannot be guaranteed.

    Product
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1336-2018·2018-04-18

    Arrow Hemodialysis Catheter Kits Recalled for Sterility Concerns

    Arrow International is recalling specific lots of hemodialysis catheterization kits because they may not be completely sealed, potentially compromising sterility.

    Product
    ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1363-2018·2018-04-18

    Orthofix Recalls Connector System Set Screws Due to Size Discrepancies

    Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may prevent proper driver fit or cause stripping.

    Product
    ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1371-2018·2018-04-18

    Hamilton-C2 Ventilator Units Recalled Due to Battery Fuel Gauge Inaccuracy

    Hamilton Medical AG is recalling 739 Hamilton-C2 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.

    Product
    Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1360-2018·2018-04-18

    Zimmer GmbH Recalls Normed Charcot Osteotome Chisels for Disinfection Gap

    Zimmer GmbH is recalling Normed Charcot Osteotome Chisels because a gap between the handle and metal chisel may prevent proper disinfection or sterilization between uses.

    Product
    Normed Charcot Osteotome Chisel (Various sizes)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1366-2018·2018-04-18

    Beckman Coulter iQ200 Urine Analyzer Recall for Barcode Reading Failures

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may fail to read dilution barcodes, causing erroneous results that could delay treatment.

    Product
    iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2018·2018-04-18

    Beckman Coulter iQ200 Urine Analyzer Recall for Under-Reporting Issue

    Beckman Coulter is recalling the iQ200 Series Urine Microscopy Analyzer because it may under-report casts when certain measurement settings are used. The issue could affect test results during initial setup or after settings are changed.

    Product
    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1354-2018·2018-04-18

    Bard Premature Infant Feeding Tube Recalled for Ineffective Fusion

    C.R. Bard is recalling 42,200 units of Bard Premature Infant Feeding Tubes due to potentially ineffective fusion between the tubing and the ENFit connector.

    Product
    Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V242000·2018-04-17

    KZRV Recalls 2018-2019 Trailers Due to Awning Deployment Risk

    KZRV is recalling 2018-2019 recreational trailers because the awning may deploy while moving, increasing the risk of a crash.

    Product
    KZRV — KZRV CONNECT, VENOM, SPORTSMEN, SPREE
    Category
    Vehicle
    Distribution
    Distributed nationwide