The Recall Desk

Archive

June 2019 recalls

686 recalls were announced in June 2019.

What the numbers show

Critical
12
Severe
191
High
347
Moderate
123
Low
13

Of the 686 recalls this month scored against our rubric, 2% are Critical, 28% are Severe.

301–400 of 686

  • HighNHTSA·19V464000·2019-06-18

    Farber Recalls 2018 International 4300 Vehicles with Whelen Brake Lights

    Farber Specialty Vehicles is recalling 2018 International 4300 SBA vehicles equipped with Whelen brake lights that may illuminate without the brake pedal being pressed.

    Product
    INTERNATIONAL — INTERNATIONAL 4300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V466000·2019-06-18

    SVO Group Recalls 2017-2018 Ford E-350 and E-450 Shuttle Buses

    SVO Group is recalling 2017-2018 Ford E-350 and E-450 shuttle buses because backup camera images may reverse, increasing crash risk.

    Product
    FORD — FORD E-350, E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V463000·2019-06-18

    Farber Recalls 2017 Ford F-550 Vehicles Due to Brake Light Wiring Issue

    Farber Specialty Vehicles is recalling 2017 Ford F-550s with Whelen brake lights that may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    FREIGHTLINER — FREIGHTLINER redundant FORD F550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V455000·2019-06-17

    Altec Recalls 2017-2018 Aerial Devices Due to Fastener Failure Risk

    Altec is recalling 2017-2018 aerial devices because fasteners securing the rotation bearing may break, potentially causing the pedestal to separate from the turntable.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V454000·2019-06-17

    Forest River Berkshire Motorhomes Recalled for Block Heater Fire Risk

    Forest River is recalling 2017-2018 Berkshire motorhomes because water in the block heater cable can cause corrosion, leading to overheated wiring and fire risk.

    Product
    FOREST RIVER — FOREST RIVER BERKSHIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·065-2019 EXP·2019-06-14

    Table 87 Frozen Recalls Pork and Beef Pizza Products Lacking Federal Inspection

    Table 87 Frozen, LLC is recalling frozen pork and beef pizza products produced without federal inspection. No adverse reactions have been reported.

    Product
    Table 87 Frozen, LLC — Table 87 Frozen, LLC Recalls Pork and Beef Pizza Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V456000·2019-06-14

    Autocar Recalls 2013-2018 Xpeditor Vehicles for Drive Shaft Support Defect

    Autocar is recalling 2013-2018 Xpeditor vehicles because the drive shaft support cross member may fail, increasing crash risk. Dealers will install additional support brackets free of charge.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V462000·2019-06-14

    Caterpillar Recalls 2015-2019 Progress Rail Sky Trim Hi-Rail Vehicles

    Caterpillar is recalling 2015-2019 Progress Rail Sky Trim Hi-Rail vehicles because a support plate may block driver visibility and the boom may detach from the cradle while in motion.

    Product
    PROGRESSIVE RAIL SERVICES — PROGRESSIVE RAIL SERVICES SKY TRIM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·069-2019·2019-06-14

    Ruiz Foods Recalls Bacon Breakfast Wraps Due to Foreign Matter Contamination

    Ruiz Foods is recalling approximately 246,514 pounds of frozen bacon breakfast wraps due to possible contamination with small rocks.

    Product
    Ruiz Food Products, Inc. — Ruiz Foods Products Inc. Recalls Bacon Breakfast Wrap Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V457000·2019-06-14

    Mercedes-Benz Recalls AMG GT Vehicles for Driveshaft Separation Risk

    Mercedes-Benz is recalling 2016-2017 AMG GT vehicles because the carbon-fiber driveshaft may separate, causing a loss of drive and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V452000·2019-06-14

    Peterbilt 320 and 520 Trucks Recalled for Rear Turn Signal Defect

    PACCAR is recalling 1990-2020 Peterbilt 320 and 520 trucks because rear turn signals may illuminate with brake lights, increasing crash risk.

    Product
    PETERBILT — PETERBILT 520, 320
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V458000·2019-06-14

    Mercedes-Benz Recalls 2020 GLE Models Due to Air Bag Deployment Issues

    Mercedes-Benz is recalling 2020 GLE 350 and GLE 450 vehicles because the passenger air bag may deploy slowly or not at all in hot conditions, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V459000·2019-06-14

    Mercedes-Benz Recalls 2020 GLE Models Due to Floor Welding Error

    Mercedes-Benz is recalling 2020 GLE 350 and GLE 450 vehicles because a welding error may allow water to leak into the cabin, potentially affecting electrical systems.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V451000·2019-06-14

    Gillig Low Floor Vehicles Recalled for Glass Roof Hatch Shattering Risk

    Gillig is recalling 2018-2019 Low Floor vehicles because temperature and vibration stresses may cause the tempered glass roof hatch to shatter, potentially injuring passengers.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V450000·2019-06-13

    Roadtrek Motorhomes Recalled for Weak Second-Row Seat Anchor Brackets

    Erwin Hymer is recalling 2013-2019 Roadtrek motorhomes because second-row seat anchor brackets may lack sufficient strength, increasing injury risk in a crash.

    Product
    ROADTREK — ROADTREK CS ADVENTUROUS, RS ADVENTUROUS, E-TREK, TS ADVENTUROUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E040000·2019-06-13

    Cummins Recalls School Bus Hybrid Propulsion Control Units

    Cummins is recalling Vehicle Control Units for PowerDrive 7000 EV school buses because they may unexpectedly shut down, causing loss of drive and power steering.

    Product
    HYBRID PROPULSION SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V447000·2019-06-13

    Jeep Cherokee Recall: Transmission Software May Shift to Neutral

    Chrysler is recalling 2014 Jeep Cherokee vehicles with 3.2L engines because a stuck clutch may cause the transmission to shift to neutral, increasing crash risk.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V449000·2019-06-13

    Jeep Cherokee Recall for Air Bag Sensor Defect

    Chrysler is recalling 2019 Jeep Cherokee vehicles because air bag sensors may fail, potentially preventing proper deployment in a crash.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1438-2019·2019-06-12

    Icco Cheese Co Recalls Gia Russa Bread Crumbs for Undeclared Allergens

    Icco Cheese Co Inc is recalling Gia Russa Whole Grain Italian Seasoned Bread Crumbs because the product contains undeclared walnuts and pecans.

    Product
    Gia Russa Whole Grain Italian Seasoned Bread Crumbs in 10 Oz Paperboard Canisters
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1734-2019·2019-06-12

    Getinge Meera Mobile Operating Table Recalled for Electric Shock Risk

    Maquet Cardiovascular is recalling Getinge Meera Mobile Operating Tables because exposed electronic components may cause electric shock to users.

    Product
    GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient im
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1710-2019·2019-06-12

    BD Nexiva IV Catheter System Recalled for Septum Leak Risk

    Becton Dickinson is recalling 6,720 units of BD Nexiva Dual Port 20GA IV Catheter Systems due to a potential leak that could expose health care workers to blood.

    Product
    BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1229-2019·2019-06-12

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect

    OriGen Biomedical is recalling 66 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of the clear tube disconnecting from the hub if clamped improperly.

    Product
    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
    Category
    Medical Device
    Distribution
    33 states
  • SevereNHTSA·19V445000·2019-06-12

    Porsche Recalls 2019-2020 Models for Driveshaft Bolt Tightening Issue

    Porsche is recalling 2019 911 GT2 RS and 2020 911 Carrera S Coupe vehicles because driveshaft bolts may not be properly tightened, increasing crash risk.

    Product
    PORSCHE — PORSCHE 911 GT2, 911 CARRERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·068-2019·2019-06-12

    Greener Pastures Chicken Recalls Raw Whole Poultry Produced Without Inspection

    Pasture Raised Foods, LLC is recalling raw whole poultry produced without federal inspection. The products were shipped to locations in Texas.

    Product
    Pasture Raised Foods, LLC Recalls Raw Whole Poultry Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1433-2019·2019-06-12

    Topnotch Foods Natural Bread Crumbs Recalled for Undeclared Milk

    Topnotch Foods Inc is recalling 2,000 lbs of Natural Bread Crumbs due to undeclared milk. The product was distributed in California.

    Product
    Topnotch Foods Natural Bread Crumbs: 50 lb. Net Wt. 22.68 kg. and 10 lbs. 4.54 Kg. Item number 10021: Vernon, CA Correct Ingredients: Enriched, Bleached & Unbleached, Wheat Flour, [Flour, Malted Barley Flour, Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Foli
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1231-2019·2019-06-12

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Failure Risk

    OriGen Biomedical is recalling 61 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection from the hub caused by adhesive failure.

    Product
    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
    Category
    Medical Device
    Distribution
    33 states
  • SevereNHTSA·19V446000·2019-06-12

    Porsche Recalls Vehicles Due to Gear Selector Bushing Defect

    Porsche is recalling specific Cayenne and Panamera models because a degraded bushing may allow the driver to exit the vehicle while the transmission is not in Park, increasing crash risk.

    Product
    PORSCHE — PORSCHE PANAMERA 4S, PANAMERA, CAYENNE S, CAYENNE TURBO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1720-2019·2019-06-12

    Centurion Medical Recalls Sterile Nail Nippers Due to Compromised Seal

    Centurion Medical Products Corporation is recalling sterile nail nippers because the sterile barrier pouch seal is compromised, potentially affecting sterility.

    Product
    Sterile Nail Nipper, Barrel Spring (I68400), Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures

    AngioDynamics is recalling 314 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1729-2019·2019-06-12

    Leica Cryostats Recalled for Missing Flammable Spray Warning

    Leica Microsystems is recalling 17,179 cryostats because the labels lack warnings about the fire risk associated with flammable freezing sprays.

    Product
    Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1701-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures

    AngioDynamics is recalling 178 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1482-2019·2019-06-12

    Young Ocean Seasoned Alaskan Pollock Roe Recalled for Undeclared Allergens

    Young Ocean is recalling Seasoned Alaskan Pollock Roe because the label fails to declare bonito and lactose (milk) as ingredients.

    Product
    Young Ocean brand Seasoned Alaskan Pollock Roe, frozen, wrapped in plastic liner and packed in styrofoam box, and finally packed in cardboard box. Net wt. per pack: 1 lb. Each cardboard box contains 20/1 lb. packs. The label is read in parts: "***Seasoned Alaskan Pollock Roe
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1713-2019·2019-06-12

    Flowonix Prometra Programmer Software Recall for Unexpected Pump Shutdowns

    Flowonix Medical Inc is recalling 40 units of Prometra Programmer software due to a defect that causes intrathecal pumps to shut down unexpectedly.

    Product
    Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2019·2019-06-12

    Accuray Recalls CyberKnife M6 Systems Due to Collimator Housing Drop Risk

    Accuray is recalling 68 CyberKnife M6 systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.

    Product
    CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: Cyb
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1740-2019·2019-06-12

    Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk

    Zimmer Biomet is recalling 14 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials were used, potentially leading to corrosion.

    Product
    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1727-2019·2019-06-12

    Stryker High Flow Tube Set Recalled for Leaking and Detachment

    Stryker is recalling High Flow Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.

    Product
    Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures

    AngioDynamics is recalling 7,348 Solero Microwave Tissue Ablation applicators to update manuals and software, reducing the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2019·2019-06-12

    Flowonix Prometra Clinician Programmer Software Recall for Unexpected Pump Shutdowns

    Flowonix Medical Inc is recalling Prometra Clinician Programmer software due to a defect that can cause intrathecal pumps to shut down unexpectedly.

    Product
    Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1694-2019·2019-06-12

    Philips IntelliVue MX40 Patient Monitor Recalled for Battery Notification Issues

    Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible low-battery alerts, potentially disrupting patient monitoring.

    Product
    IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1726-2019·2019-06-12

    Stryker High Flow II Tube Set Recalled for Leaking and Detachment

    Stryker is recalling High Flow II Tube Sets because they consistently leak and detach from the cassette. The product is a medical device accessory distributed nationwide and internationally.

    Product
    Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2019·2019-06-12

    Bio-Rad Recalls MRSASelect II Diagnostic Plates Due to Abnormal Coloration

    Bio-Rad Laboratories is recalling MRSASelect II diagnostic plates due to abnormal agar coloration and non-characteristic colony growth. The recall covers 3,632 units distributed nationwide.

    Product
    MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2019·2019-06-12

    Philips IntelliVue MX40 Patient Monitor Recalled for Battery Defect

    Philips is recalling IntelliVue MX40 Patient Monitors because they may experience increased power consumption and lack visual or audible notifications when in a low battery state.

    Product
    IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connecte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1477-2019·2019-06-12

    Sassy Cow Creamery Recalls Ice Cream Due to Undeclared Pecan Allergen

    Sassy Cow Creamery is recalling Art Cream Gluten Free Cookies & Cream ice cream because it was packaged in a container labeled for a different flavor, creating an undeclared pecan allergen risk.

    Product
    Art Cream Gluten Free Cookies & Cream ice cream, one pint. UPC 57897-00803. Products have been manufactured on Shared Equipment that Processes Peanuts, Tree Nuts, Milk, Wheat and Soybean Products.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1434-2019·2019-06-12

    Topnotch Foods Italian Bread Crumbs Recalled for Undeclared Soy Lecithin

    Topnotch Foods Inc. is recalling 10 lb. bags of Italian Bread Crumbs found to contain undeclared soy lecithin during a California Department of Public Health inspection.

    Product
    Topnotch Foods Italian Bread Crumbs: 10 lb. Net Wt.. 10 lbs. (4.54 Kg) Item number 10008: Vernon, CA 90058 Correct ingredients: CRUMBS: Enriched, Bleached & Unbleached Wheat Flour, [Flour, Malted Barley Flour, Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Foli
    Category
    Food
    Distribution
    1 state
  • HighCPSC·19136·2019-06-12

    Hayward Pool Heater Vent Kits Recalled Due to Carbon Monoxide Risk

    Hayward Industries is recalling specific pool heater vent kits because improper sizing may allow carbon monoxide leaks. Consumers should stop using affected heaters and contact the company for a free replacement.

    Product
    Hayward Vent Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1437-2019·2019-06-12

    Icco Cheese Co Recalls Gia Russa Bread Crumbs for Undeclared Allergens

    Icco Cheese Co Inc is recalling Gia Russa Whole Grain Italian Unseasoned Bread Crumbs because the product contains undeclared walnuts and pecans.

    Product
    Gia Russa Whole Grain Italian Unseasoned Bread Crumbs in 10 Oz Paperboard Canisters
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2019·2019-06-12

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Bond Failure

    OriGen Biomedical is recalling 72 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection from the hub caused by adhesive failure.

    Product
    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1227-2019·2019-06-12

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Failure Risk

    OriGen Biomedical is recalling 260 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection caused by adhesive failure.

    Product
    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Food)·F-1436-2019·2019-06-12

    New Seasons Market Recalls Bacon Shallot Potato Salad for Undeclared Egg

    New Seasons Market LLC is recalling Bacon Shallot Potato Salad sold in Oregon due to undeclared egg. The product was sold from the deli case between May 16 and May 21, 2019.

    Product
    Bacon Shallot Potato Salad, internal item PLU code 52365, sold as bulk from the full service deli case per costumers order. The salad was packed into plastic deli containers. The label is read in parts: "*** Potatoes, red wine vinaigrette (Dijon mustard [water, mustard seed
    Category
    Food
    Distribution
    1 state
  • HighCPSC·19137·2019-06-12

    Mares Recalls XR Buoyancy Compensation Vests Due to Drowning Hazard

    Mares is recalling XR buoyancy compensation vests because the deflation button can unscrew, causing loss of buoyancy and a drowning hazard. No injuries have been reported.

    Product
    Mares XR buoyancy compensation vests
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2019·2019-06-12

    Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk

    Zimmer Biomet is recalling 41 Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used in the screw component, which could lead to corrosion.

    Product
    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1693-2019·2019-06-12

    Philips IntelliVue MX40 Patient Monitor Recalled for Battery Issues

    Philips is recalling IntelliVue MX40 Patient Monitors because they may consume excess power and fail to provide visual or audible low-battery alerts.

    Product
    IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product Usage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2019·2019-06-12

    Centurion Medical Recalls Sterile Nail Clippers Due to Compromised Seals

    Centurion Medical Products Corporation is recalling sterile nail clippers because the sterile barrier pouch seals are compromised, potentially affecting sterility.

    Product
    Sterile Nail Clipper Concave Edge (67710)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2019·2019-06-12

    Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk

    Zimmer Biomet is recalling 15 Oxford Partial Knee drill guides because incorrect raw materials may cause the screw component to corrode.

    Product
    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1725-2019·2019-06-12

    Cook Inc. Recalls Thoracentesis Sets with Small Catheter Holes

    Cook Inc. is recalling 5 units of Thoracentesis Sets (Lot NS7662071) because the catheter distal end hole may be too small.

    Product
    Thoracentesis Set, RPN C-THS-850, Order # G03286
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1724-2019·2019-06-12

    Cook Inc. Recalls Pericardiocentesis Catheter Trays Due to Small Distal Hole

    Cook Inc. is recalling two Pericardiocentesis Catheter Trays because the catheter distal end hole may be too small. The affected units were distributed domestically and internationally.

    Product
    Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1717-2019·2019-06-12

    OMNIBotics iBlock Cutting Guide Recalled for Failure to Lock During Surgery

    OMNIlife science Inc. is recalling 9 OMNIBotics iBlock Cutting Guides because they may not lock onto the iBlock Saw Guide as intended and could loosen during use.

    Product
    OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedure Risk

    AngioDynamics is recalling Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from delayed procedures via manual and software updates.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1704-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Procedure Delay Risk

    AngioDynamics is recalling 1,846 Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2019·2019-06-12

    Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Material Error

    Zimmer Biomet is recalling 11 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used, potentially leading to corrosion.

    Product
    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1714-2019·2019-06-12

    Flowonix Prometra Programmable Pump Recalled for Unexpected Shutdowns

    Flowonix Medical Inc. is recalling 809 Prometra Programmable Pumps because a software defect can cause the pump to shut down unexpectedly.

    Product
    Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2019·2019-06-12

    Microline TLS2 Thermal Ligating Shears Recalled for Actuation Failure

    Microline Surgical is recalling 115 TLS2 Thermal Ligating Shears because they fail to actuate, preventing them from performing their intended surgical function.

    Product
    TLS2 Thermal Ligating Shears, Catalog Number 132-131D
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1737-2019·2019-06-12

    Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Material Error

    Zimmer Biomet is recalling 10 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used, potentially leading to corrosion.

    Product
    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1715-2019·2019-06-12

    Flowonix Prometra II Pump Recall for Unexpected Shutdowns

    Flowonix Medical Inc is recalling 6,445 Prometra II Programmable Pumps because a software defect can cause the device to shut down unexpectedly.

    Product
    Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2019·2019-06-12

    Stryker AXS Infinity LS Plus Long Sheath Recalled for Brittle Behavior

    Stryker Neurovascular is recalling AXS Infinity LS Plus Long Sheaths because a design issue can cause the device to become brittle and fracture.

    Product
    Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Lon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2019·2019-06-12

    Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk

    Zimmer Biomet is recalling 3 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials may cause corrosion.

    Product
    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1695-2019·2019-06-12

    Philips IntelliVue MX40 Patient Monitor Recalled for Battery Notification Defects

    Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible alerts when the battery is low.

    Product
    IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2019·2019-06-12

    Flowonix Prometra II Pump Recall for Unexpected Shutdowns

    Flowonix Medical Inc. is recalling 163 Prometra II Programmable Pumps due to a software defect that can cause unexpected shutdowns.

    Product
    Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1697-2019·2019-06-12

    Accuray CyberKnife VSI Robotic Radiosurgery Systems Recalled for Collimator Housing Drop

    Accuray is recalling 43 CyberKnife VSI systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.

    Product
    CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1728-2019·2019-06-12

    Stryker Heated Tube Set Recall for Leaking and Detachment Issues

    Stryker is recalling 19,083 boxes of Heated Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.

    Product
    Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1709-2019·2019-06-12

    Abbott Recalls Alinity c Cuvette Segments Due to Seating Defect

    Abbott is recalling Alinity c Cuvette Segments because individual cuvettes may seat lower than designed, potentially preventing the sample probe from making efficient contact with the cuvette bottom.

    Product
    Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and auto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1742-2019·2019-06-12

    Bio-Rad Recalls MRSASelect In Vitro Diagnostic Plates Due to Abnormal Coloration

    Bio-Rad Laboratories is recalling 5,212 units of MRSASelect in vitro diagnostic plates due to abnormal agar coloration and non-characteristic colony growth.

    Product
    MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1718-2019·2019-06-12

    I.T.S. GmbH Recalls Titanium Rim Plates Due to Incorrect Laser Marking

    I.T.S. GmbH is recalling 65 titanium rim plates because they have the wrong article number laser marked on them. The devices were distributed in the US and several international countries.

    Product
    Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1731-2019·2019-06-12

    Microbiologics Recalls Cepheid Xpert SA Nasal Control Panels for Shelf Life Error

    Microbiologics is recalling 235 units of Cepheid Xpert SA Nasal Complete Control Panels due to incorrect shelf life labeling.

    Product
    Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2019·2019-06-12

    Smiths Medical Recalls Portex Tracheostomy Tubes with Incorrect Inner Cannula Size

    Smiths Medical ASD Inc. is recalling 7,840 Portex Blue Line Ultra Tracheostomy Tubes because they were packaged with an incorrect size inner cannula.

    Product
    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1730-2019·2019-06-12

    Microbiologics Recalls Cepheid Xpert MRSA Control Panels Due to Incorrect Shelf Life

    Microbiologics Inc is recalling 249 units of Cepheid Xpert MRSA/MRSA NxG and Xpert SA Nasal Complete Control Panels because they have an incorrect shelf life.

    Product
    Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1721-2019·2019-06-12

    Kerr/Pentron Recalls Glutaraldehyde Solution Due to Labeling Discrepancy

    Kerr/Pentron is recalling Regimen 28 Day Glutaraldehyde Solution because the bottle label states a 45-minute immersion time, while the product instructions specify 90 minutes.

    Product
    Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1733-2019·2019-06-12

    Smith Medical JELCO Hypodermic Needle Recall for Incorrect Specifications

    Smiths Medical ASD Inc. is recalling JELCO Hypodermic Needles with incorrect length and gauge. The recall covers 109,000 units distributed nationwide.

    Product
    Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1435-2019·2019-06-12

    Value Added Products Recalls 10.5 Inch Flat Edge Pizza Crust

    Value Added Products is recalling 10.5-inch Flat Edge Pizza Crust due to a potential plastic bag liner in the food product.

    Product
    10.5 " Flat Edge Pizza Crust, packaged in a box with 40 pieces per box
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1735-2019·2019-06-12

    Zimmer Biomet Recalls Lineum Translation Screws Due to Incorrect Length Marking

    Zimmer Biomet is recalling 64 Lineum 4.35mm x 28mm Translation Screws because the tulip head is incorrectly etched with '24MM' instead of '28MM'.

    Product
    Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to resto
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1707-2019·2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling specific lots of PureFlow B Solution because they were mislabeled with the incorrect product number.

    Product
    NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1706-2019·2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling 1,998 units of PureFlow B Solution because certain lots were mislabeled with the incorrect product number.

    Product
    NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1699-2019·2019-06-12

    Fresenius 2008T BlueStar Hemodialysis Machines Recalled for Power Logic Board Fail Message

    Fresenius Medical Care is recalling 257 units of the 2008T BlueStar hemodialysis machine due to a power logic board fail message on software version 2.72.

    Product
    2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V443000·2019-06-11

    Freightliner M2 and 108SD Trucks Recalled for Axle Lubrication Defect

    Daimler Trucks North America is recalling 2019-2020 Freightliner M2 and 2020 108SD trucks because insufficient axle lubrication may damage wheel bearings, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V444000·2019-06-11

    Thomas Built Buses Recall School Buses Due to Dragging Rear Brakes

    Daimler Trucks North America is recalling specific Thomas Built Buses school buses because the driver-side rear brakes may drag, increasing the risk of smoke and fire.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V436000·2019-06-11

    Entegra Recalls 2020 Motorhomes Due to Steering Shaft Bolt Issue

    Entegra is recalling 2020 Anthem and Cornerstone motorhomes because an insufficiently tightened steering shaft bolt may cause steering failure, increasing crash risk.

    Product
    ENTEGRA — ENTEGRA ANTHEM, CORNERSTONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19751·2019-06-11

    Cushy Form Recalls Folding Mattresses for Fire Hazard

    Cushy Form is recalling about 2,300 folding mattresses sold on Amazon.com because they fail to meet federal flammability standards, posing a fire hazard.

    Product
    Cushy Form folding mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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