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.

29526–29550 of 50499

  • HighFDA (Devices)·Z-1101-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they are breaking at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0938-2018·2018-03-28

    ASR Group Recalls Sugar Syrup Due to Foreign Metal Material

    ASR Group International Inc. is recalling approximately 50,000 wet pounds of Tank Truck #2 Sugar Syrup because it may contain foreign metal material.

    Product
    Tank Truck #2 Sugar Syrup (403764)
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·18V202000·2018-03-28

    REV Recalls Motorhomes Due to Potential Satellite Dish Detachment

    REV is recalling 2017-2018 motorhomes because satellite dish mounting screws may not be fastened correctly, posing a crash risk if the dish detaches.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, AMERICAN COACH, FLEETWOOD PRODIGY, AMERICAN EAGLE, NAVIGATOR, PULSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2018·2018-03-28

    MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 55 Tesio Catheter Sets because potential connection failures could lead to blood loss or air emboli.

    Product
    12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2018·2018-03-28

    Smiths Medical Recalls Medfusion Syringe Pumps Due to Syringe Recognition Issues

    Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

    Product
    Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1018-2018·2018-03-28

    Oregon Food Bank Recalls Roasted Pumpkin Seeds Due to Listeria

    Oregon Food Bank is recalling roasted pumpkin seeds because a Certificate of Analysis confirmed the presence of Listeria species.

    Product
    Roasted Pumpkin Seeds, packaged in 1 lbs. poly film bags with a twist type closure or in a re-sealable pouch, labeled as "distributed by Oregon Food Bank". Product was also distributed in packages labeled as Kale Joy brand.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1091-2018·2018-03-28

    Centurion Medical Recalls Latex Free IV Start Sets

    Centurion Medical Products Corporation is recalling Latex Free IV Start Sets due to a Class II FDA recall. The products were distributed nationally.

    Product
    LATEX FREE IV START SET
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0936-2018·2018-03-28

    Adams Reserve Fajita Grilling Rub Recalled for Undeclared Wheat

    Adams Extract & Spice LLC is recalling Adams Reserve Fajita Grilling Rub bottles due to undeclared wheat. The product was distributed in Texas.

    Product
    Adams Reserve, Fajita Grilling Rub 5.7 oz. Bottle Item Code: 04544, 12 bottles per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1157-2018·2018-03-28

    Bovie J-Plasma Precise FLEX Recall for Incomplete Cable Seal

    Bovie Medical is recalling 12 units of the J-Plasma Precise FLEX due to a potential seal failure that could allow patient fluid backflow and cross-contamination.

    Product
    J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1126-2018·2018-03-28

    MedComp Catheter Repair Kit Recalled for Potential Connection Failures

    Medical Components, Inc. is recalling 315 Catheter Repair Kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2018·2018-03-28

    Siemens Artis one Fluoroscopic X-Ray System Recalled for Table Defect

    Siemens is recalling 16 Artis one fluoroscopic x-ray systems because a missing or incorrect snap ring could cause the tabletop to slide to the floor.

    Product
    Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1095-2018·2018-03-28

    Centurion Medical Recalls Neonatal IV Start Kits Due to Quality Concerns

    Centurion Medical Products Corporation is recalling specific lots of Neonatal IV Start Kits. The recall is a Class II action, indicating a potential risk of temporary or medically reversible health consequences.

    Product
    NEONATAL IV START KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0604-2018·2018-03-28

    Fresenius Recalls DELFLEX Peritoneal Dialysis Solution Due to Bag Leakage

    Fresenius Medical Care is recalling specific lots of DELFLEX Peritoneal Dialysis Solution because bag leakage may compromise sterility.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1156-2018·2018-03-28

    Bovie Medical Recalls J-Plasma Precise 360 Devices Due to Seal Defect

    Bovie Medical is recalling J-Plasma Precise 360 devices because a cable plug defect may allow patient fluid to backflow, creating a risk of cross-contamination.

    Product
    J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1169-2018·2018-03-28

    Beckman Coulter AutoMate Systems Recalled for Premature Belt Failure

    Beckman Coulter is recalling AutoMate 1200, 1250, 2500, and 2550 systems due to premature belt failure that poses a remote risk of cross-contamination.

    Product
    AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1092-2018·2018-03-28

    Centurion Medical Recalls Pediatric IV and IV Start Kits

    Centurion Medical Products Corporation is recalling Pediatric IV & IV Start Kits. The recall is classified as Class II by the FDA.

    Product
    PEDIATRIC IV & IV START KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0979-2018·2018-03-28

    Trader Joe's Peanut Butter Cookies Recalled Due to Mislabeling

    Food and Beverage Inc. is recalling Trader Joe's Peanut Butter Sutter's Formula Cookies because they were packed in Chocolate Chip Cookie bags, posing a peanut allergy risk.

    Product
    Name: Trader Joe s Chocolate Chip Cookies SKU 68075 Net Weight: 12 oz. (340g) Number of units per package: 16 cookies Package type: Kraft paper bag
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1120-2018·2018-03-28

    MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 712 Tesio catheter sets because connection failures could cause blood loss or air emboli.

    Product
    12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1154-2018·2018-03-28

    Bovie Medical Recalls J-Plasma Precise Devices Due to Cross-Contamination Risk

    Bovie Medical is recalling J-Plasma Precise devices because a cable plug defect may allow patient fluid to backflow, creating a risk of cross-contamination.

    Product
    J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1102-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1151-2018·2018-03-28

    Beckman Coulter AutoMate 2500 Chemistry Analyzer Recall for Sensor Defect

    Beckman Coulter is recalling AutoMate 2550 and 1250 chemistry analyzers because a misaligned sensor may fail to detect missing pipette tips, posing a remote risk of cross-contamination.

    Product
    AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2018·2018-03-28

    Merit Medical Recalls Misconfigured Peritoneal Dialysis Catheters

    Merit Medical Systems is recalling 30 Flex-Neck Classic Peritoneal Dialysis Catheters because 2-cuff devices were incorrectly configured and labeled as 1-cuff products.

    Product
    Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
    Category
    Medical Device
    Distribution
    0 states