The Recall Desk

Archive

July 2019 recalls

903 recalls were announced in July 2019.

What the numbers show

Critical
24
Severe
150
High
252
Moderate
463
Low
14

Of the 903 recalls this month scored against our rubric, 3% are Critical, 17% are Severe.

501–600 of 903

  • ModerateFDA (Devices)·Z-2031-2019·2019-07-31

    Siemens Artis zee Biplane Recalled for Generator Power Supply Tolerance Issue

    Siemens is recalling 268 Artis zee biplanes because a power supply tolerance issue may cause generator failure, preventing X-ray production during procedures.

    Product
    Artis zee biplane, Model Number 10094141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2077-2019·2019-07-31

    Getinge Recalls Seven PulsioFlex Monitoring Systems Due to Error Messages

    Getinge US Sales LLC is recalling seven PulsioFlex Monitoring Systems because they display an internal error message requiring restart or service.

    Product
    PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2015-2019·2019-07-31

    Siemens AXIOM Artis BC X-ray Generator Recall Due to Power Supply Issue

    Siemens is recalling six AXIOM Artis BC units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.

    Product
    AXIOM Artis BC, Model Number 5904649
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2017-2019·2019-07-31

    Siemens AXIOM Artis dBC X-ray System Recalled for Power Supply Issue

    Siemens is recalling one AXIOM Artis dBC X-ray system because a power supply defect may prevent X-ray generation during procedures.

    Product
    AXIOM Artis dBC, Model Number 5917054
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2020-2019·2019-07-31

    Siemens AXIOM Artis dFC X-ray Generator Recall for Power Supply Issue

    Siemens is recalling 148 AXIOM Artis dFC units because a power supply defect may cause the X-ray generator to fail during procedures.

    Product
    AXIOM Artis dFC, Model Number 7412807
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1790-2019·2019-07-31

    Jell-O Sugar Free Chocolate Pudding Recalled for Temperature Control Failure

    C & S Wholesale Grocers is recalling Jell-O Sugar Free Chocolate Pudding sold at two Target stores in New York because the product was not held at appropriate temperatures during transport.

    Product
    JELL-O SUGAR FREE CHOCOLATE PUDDING - 29OZ/8PK UPC: 4300005088
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-2079-2019·2019-07-31

    Abbott Recalls ARCHITECT BNP Controls Due to Stability Drift

    Abbott Laboratories is recalling ARCHITECT BNP Controls because of a time-dependent stability drift that affects test results.

    Product
    ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1518-2019·2019-07-31

    Lupin Recalls Nystatin and Triamcinolone Acetonide Cream for Stability Failure

    Lupin Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream due to a failed uniformity of containers test. The recall covers 33,939 tubes distributed nationwide.

    Product
    NYSTATIN AND TRIAMCINOLONE ACETONIDE — NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·19V558000·2019-07-29

    Mazda Recalls 2019 Mazda3 Vehicles for Rearview Mirror Defect

    Mazda is recalling 2019 Mazda3 vehicles with manual dimming mirrors because the mirror may detach, reducing rearward visibility and increasing crash risk.

    Product
    MAZDA — MAZDA MAZDA3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·080-2019·2019-07-27

    Premium Foods USA Recalls Siluriformes Fish Products Lacking Import Inspection

    Premium Foods USA is recalling 121,151 pounds of Siluriformes fish products imported from ineligible countries without required inspection.

    Product
    Premium Foods USA, Inc., Recalls Siluriformes Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·19V561000·2019-07-26

    Moto Guzzi and Aprilia Motorcycles Recalled for Front Brake Master Cylinder Defect

    Piaggio is recalling specific Moto Guzzi and Aprilia motorcycles because a front brake master cylinder defect may cause unexpected slowing or stopping without warning to following traffic.

    Product
    MOTO GUZZI — MOTO GUZZI, APRILIA CALIFORNIA, DORSODURO, ELDORADO, AUDACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·079-2019·2019-07-26

    Kent Quality Foods Recalls Sausage Due to Foreign Matter

    Kent Quality Foods is recalling ready-to-eat Polish sausage products due to possible contamination with flexible pink rubber pieces.

    Product
    Kent Quality Foods Inc. — Kent Quality Foods, Inc. Recalls Ready-To-Eat Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·19V557000·2019-07-26

    Temsa Recalls 2014-2019 TS45 Buses for Steering Hose Defect

    Temsa is recalling 2014-2019 TS45 buses because hydraulic steering hoses may leak or burst, potentially affecting steering ability and increasing crash risk.

    Product
    TEMSA — TEMSA TS45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V556000·2019-07-26

    Chrysler Recalls 2019 Ram 1500 for Instrument Cluster Illumination Defect

    Chrysler is recalling 2019 Ram 1500 vehicles because the instrument cluster may fail to illuminate driver warnings, increasing crash risk. Dealers will replace the cluster free of charge.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V555000·2019-07-26

    Starcraft Bus Recalls 2018-2019 Models Due to Roof Hatch Handle Defect

    Forest River is recalling 2018-2019 Starcraft Allstar, Allstar XL, and Starlite vehicles because the roof hatch external handle may break, preventing emergency egress.

    Product
    STARCRAFT BUS — STARCRAFT BUS ALLSTAR, STARLITE, ALLSTAR XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19764·2019-07-26

    Spansive Recalls Wireless Phone Chargers Due To Burn Hazard

    Spansive is recalling about 950 wireless multi-phone chargers sold in May 2019 because metallic accessories can overheat, posing a burn hazard.

    Product
    Spansive Source wireless, multi-phone chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalCPSC·19175·2019-07-25

    Cannondale CAADX Bicycles Recalled Due to Fork Breakage and Fatality Risk

    Cycling Sports Group is recalling 2013-2016 Cannondale CAADX bicycles because the fork can break, posing a fall hazard. One fatality and seven serious injuries have been reported.

    Product
    2013 through 2016 Cannondale CAADX cyclocross bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·078-2019·2019-07-25

    Home Market Foods Recalls Frozen Meatballs for Undeclared Allergens

    Home Market Foods is recalling approximately 53,217 pounds of frozen ready-to-eat beef and pork meatballs because they contain undeclared milk and wheat allergens.

    Product
    Home Market Foods, Inc. — Home Market Foods, Inc. Recalls Frozen Ready-To-Eat Beef and Pork Meatball Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    10 states
  • HighCPSC·19763·2019-07-25

    Britax Recalls Modified Thru-Bolt Axles for BOB Jogging Strollers

    Britax is recalling modified thru-bolt axles for BOB jogging strollers because the front wheel can fracture and detach, posing fall and injury hazards.

    Product
    Modified thru-bolt axles for use with BOB Jogging Strollers distributed through the BOB Information Campaign from January 10, 2019 to April 26, 2019
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V551000·2019-07-25

    Alfa Romeo Giulia and Stelvio Recalled for Inaccurate Fuel Level Display

    FCA US LLC is recalling 2018-2019 Alfa Romeo Giulia and Stelvio vehicles because the Body Control Module may display a fuel level higher than the actual amount, increasing the risk of a crash.

    Product
    ALFA ROMEO — ALFA ROMEO GIULIA, STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19174·2019-07-25

    Stokke Recalls Steps Bouncers Due to Fall Hazard

    Stokke is recalling Steps Bouncers because they can detach from the Steps Chair, posing a fall hazard to infants.

    Product
    Stokke® Steps™ Bouncers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19E050000·2019-07-25

    Indiana Mills Recalls Inflatable Head Cushions and Knee Air Bags

    Indiana Mills and Manufacturing Inc. is recalling certain Inflatable Head Cushions and Knee Air Bags that may fail to inflate during a crash due to improper manufacturing.

    Product
    AIR BAGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V554000·2019-07-25

    Champion and Goshen Shuttle Bus Roof Hatch Handle Recall

    Champion Bus is recalling 2019 shuttle buses because the roof emergency hatch handle may break, preventing easy opening during an emergency.

    Product
    GOSHEN — GOSHEN, CHAMPION G-FORCE, PACER II, CRUSADER, LF TRANSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V552000·2019-07-25

    Cummins Generator Set Recall: Improperly Fastened Jack Handle

    MMDi is recalling 2019 Cummins 'G' A057P788 trailers because an improperly fastened jack handle may separate, creating a road hazard.

    Product
    CUMMINS POWER GENERATION — CUMMINS POWER GENERATION GENERATOR SET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V550000·2019-07-25

    Thomas Built Buses Recalling School Buses for Roof Hatch Handle Defect

    Daimler Trucks North America is recalling 2019-2020 Thomas Built school buses because the roof escape hatch handle may break, hindering emergency egress.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, MINOTOUR, SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·077-2019·2019-07-24

    CM&R Recalls Beef Snack Sticks for Undeclared Milk Allergen

    CM&R Inc. is recalling beef snack sticks that contain undeclared milk, a known allergen, due to misbranding.

    Product
    CM & R, Inc. — CM&R Inc. Recalls Beef Stick Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1560-2019·2019-07-24

    Pure Ground Ingredients Organic Fennel Seed Recalled for Salmonella

    Pure Ground Ingredients is recalling Organic Fennel Seed in 40 lb. bags because testing found the product positive for Salmonella.

    Product
    Pure Ground Ingredients Organic Fennel Seed, Tea bag Cut 40 lb. bags; Item # FENO-TC Processed and Packaged by: Pure Ground Ingredients 2535 Business Parkway Minden, NV 89423
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1559-2019·2019-07-24

    Pure Ground Ingredients Organic Fennel Seed Recalled for Salmonella

    Pure Ground Ingredients is recalling 35 lb. bags of Organic Fennel Seed because testing found the product positive for Salmonella.

    Product
    Pure Ground Ingredients Organic Fennel Seed, Ground 35 lb. bags Item # FENO-GR Processed and Packaged by: Pure Ground Ingredients 2535 Business Parkway Minden, NV 89423
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-1912-2019·2019-07-24

    Teleflex Neonatal Breathing Circuit Recall Due to Cracked Adaptors

    Teleflex is recalling 20 units of Neonatal ConchaSmart Breathing Circuits due to reported cracks on swivel wye adaptors observed prior to use.

    Product
    Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1571-2019·2019-07-24

    ADM Recalls Sir Lancelot HG Flour Due to Potential E. coli O26 Presence

    ADM is recalling specific lots of Sir Lancelot HG Flour because of the potential presence of E. coli O26. Consumers should check their products and stop using them if they match the recalled lot.

    Product
    Sir Lancelot HG Flour 50lb bags Product Code 802203 Lot#: 8346BF
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1555-2019·2019-07-24

    Shelton Farms Recalls Raw Jalapenos for Salmonella Risk

    Shelton Farms is recalling raw fresh whole jalapenos due to a potential Salmonella contamination. The product was distributed to food service and retail locations in Michigan and Indiana.

    Product
    Raw fresh whole jalapeno, ambient Non-descript 10# cardboard box. Sold as 10lb unit or by the pound.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1569-2019·2019-07-24

    ADM Recalls H&R Flour Due to Potential E. coli O26 Presence

    ADM is recalling H&R Flour 50lb bags due to potential E. coli O26 presence. The product was distributed to retailers and food service locations in multiple states.

    Product
    H&R Flour (Hotel and Restaurant) 50lb bags Product Codes 706220
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1568-2019·2019-07-24

    ADM Recalls Gigantic Flour Due to Potential E. coli O26 Presence

    ADM is recalling Gigantic Flour 50lbs (Lot 8346BF) due to the potential presence of E. coli O26. The product was distributed to various retailers and commercial bakeries.

    Product
    Gigantic Flour 50lbs Product Code 701220 Lot #: 8346BF
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1562-2019·2019-07-24

    ADM Recalls Bulk Flour Due to Potential E. coli O26 Presence

    ADM is recalling bulk flour products due to the potential presence of E. coli O26. The recall affects various flour brands distributed to retailers and commercial bakeries.

    Product
    Miss Minneapolis Product Code: 803003 Bulk flour
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1556-2019·2019-07-24

    Weaver Popcorn Recalls Cheddar Popcorn Due to Salmonella Concern

    Weaver Popcorn Co. is recalling specific lots of cheddar popcorn due to a concern of possible Salmonella contamination.

    Product
    Cheddar popcorn, bulk, packaged in metalized film, Net Wt. 4.85 lbs., Item No. 107065
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1580-2019·2019-07-24

    ADM Recalls Gold Medal Flour Due to Potential E. coli O26 Presence

    ADM is recalling Gold Medal Flour Mt Bulk Product Code 805046 due to the potential presence of E. coli O26. The product was distributed to commercial bakeries and food service operators.

    Product
    Gold Medal Flour Mt Bulk Product Code 805046
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1563-2019·2019-07-24

    ADM Recalls Bulk Gold Medal Flour Due to Potential E. coli O26

    ADM is recalling 191,000 pounds of bulk Gold Medal Flour due to potential E. coli O26. The product was distributed to commercial bakeries and food service locations.

    Product
    Gold Medal Flour Product Code: 805046 Bulk flour
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·19172·2019-07-24

    Porter-Cable Table Saws Recalled by CPSC Due to Fire Hazard

    Chang Type is recalling Porter-Cable 10-inch table saws sold at Lowe's because the motors can overheat and cause fires. No injuries have been reported.

    Product
    Porter-Cable 10" Table Saws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1942-2019·2019-07-24

    Datascope CS100 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling CS100 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than the minimum run time of operating power.

    Product
    CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1943-2019·2019-07-24

    Datascope CS300 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling CS300 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time.

    Product
    CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1768-2019·2019-07-24

    CareFusion Recalls Alaris Pump Model 8100 Due to Bezel Plastic Weakening

    CareFusion is recalling Alaris Pump Model 8100 units manufactured between April 2011 and June 2017 because the bezel plastic may weaken, potentially causing infusion errors.

    Product
    Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1557-2019·2019-07-24

    Commercial Creamery Recalls White Cheddar Cheese Blend Due to Salmonella Risk

    Commercial Creamery Company of Idaho is recalling White Cheddar 5906-KD because it may be contaminated with Salmonella. The product was distributed in Iowa and Indiana.

    Product
    White Cheddar 5906-KD is a non-GMO White Cheddar Cheese Blend dried cheese powder. Product was shipped in bulk bags, net wt 50 lbs. The product label is read in parts: "***WHITE CHEDDAR BLEND 5906KD *** Net Wt. 50 lbs. ***INGREDIENTS: CHEDDAR CHEESE (Pasteurized Milk, Salt, Ch
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1558-2019·2019-07-24

    Perrigo Recalls Parent's Choice Infant Formula Due to Metal Fragments

    Perrigo Company PLC is recalling specific lots of Parent's Choice Advantage Infant Formula because the product may contain metal fragments.

    Product
    Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g, with UPC: 078742022468
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1939-2019·2019-07-24

    Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump Recalled for Labeling Defects

    Datascope Corp. is recalling 6,197 Cardiosave Hybrid Intra-Aortic Balloon Pumps worldwide due to inadequate labeling regarding battery maintenance.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1578-2019·2019-07-24

    ADM Recalls Bulk Flour Due to Potential E. coli O26 Presence

    ADM is recalling bulk flour products due to the potential presence of E. coli O26. The affected flour was distributed to retailers and commercial bakeries in multiple states.

    Product
    Springup Flr Enr, Mt Bulk Flour Product Code 703020
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1570-2019·2019-07-24

    ADM Recalls Dellalo HG Pizza Flour Due to Potential E. coli O26

    ADM is recalling Dellalo HG Pizza Flour 50lb bags due to the potential presence of E. coli O26. The product was distributed in Pennsylvania.

    Product
    Dellalo HG Pizza Flour 50lb bags Product Code 845212 Lot#: 8344BF
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1576-2019·2019-07-24

    Commander Flour Bl is recalled due to potential E. coli O26 contamination

    A flour product (Commander Flour Bl, Product Code 704060) manufactured by ADM Chicago is being recalled because there is a potential presence of E. coli O26.

    Product
    Commander Flour Bl, En, Br, Mt Product Code 704060
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1944-2019·2019-07-24

    Datascope CS300 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling CS300 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than the minimum required operating power.

    Product
    CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V544000·2019-07-24

    Toyota and Lexus Recall Vehicles for Brake Booster Pump Failure

    Toyota is recalling specific 2019-2020 hybrid and luxury vehicles because a brake booster pump failure may disable stability control and braking assist.

    Product
    TOYOTA — TOYOTA, LEXUS PRIUS PRIME, RAV4 HYBRID, UX HYBRID, LC500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1486-2019·2019-07-24

    Pfizer Recalls Milrinone Lactate Injection Bags Due to Sterility Concerns

    Pfizer is recalling 58,200 bags of Milrinone Lactate Injection in 5% Dextrose due to a lack of assurance of sterility and potential for bag leaks.

    Product
    Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-1564-2019·2019-07-24

    Recall of Pillsbury Hi Gluten Flour due to E. coli risk

    ADM is recalling Pillsbury Hi Gluten Flour because of potential E. coli O26 contamination. The affected flour was distributed to food service in New York and Pennsylvania.

    Product
    Pillsbury BALANCER HI GLUTEN FLOUR BLEACHED BROMATED ENRICHED 50 LB bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1487-2019·2019-07-24

    Pfizer Recalls Milrinone Lactate Injection Bags Due to Sterility Concerns

    Pfizer is recalling specific lots of Milrinone Lactate Injection bags because they may leak, compromising sterility.

    Product
    Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-1554-2019·2019-07-24

    Sprouts Organic Cut Leaf Spinach Recalled for Listeria

    Sprouts Farmers Market is recalling Organic Cut Leaf Spinach because testing revealed the presence of Listeria monocytogenes.

    Product
    Sprouts Farmers Market Organic Cut Leaf Spinach, Net Wt 16 Oz (1 lb), 453 g, Manufactured exclusively for Sprouts Farmers Market, Phoenix, AZ UPC 8 74875 00991 4, packaged in plastic bags, 12 bags per case.
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1977-2019·2019-07-24

    FDA Recalls Advincula Delineator Uterine Manipulator Due to Cracking Risk

    CooperSurgical is recalling 213 units of the Advincula Delineator Uterine Manipulator because the soft cup may crack during use, posing a risk of lacerations.

    Product
    Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH)
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-1978-2019·2019-07-24

    CooperSurgical Recalls Advincula Delineator Uterine Manipulator Due to Potential Cracking

    CooperSurgical is recalling 213 units of the Advincula Delineator Uterine Manipulator because the soft cup may crack during use, posing a risk of lacerations.

    Product
    Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH)
    Category
    Medical Device
    Distribution
    14 states
  • HighNHTSA·19V547000·2019-07-24

    Audi Recalls Vehicles Due to Passenger Air Bag Disabling Risk

    Audi is recalling 2017-2019 models because cable oxidation may disable the passenger air bag, increasing injury risk in a crash.

    Product
    AUDI — AUDI A5, A4 ALLROAD, RS 5, S5 CABRIOLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19173·2019-07-24

    Trek Recalls Kickster Bikes Due to Broken Steer Tube Clamp Hazard

    Trek is recalling Kickster balance bikes because the steer tube clamp can break, posing a fall hazard to children. Consumers should take bikes to a retailer for a free repair.

    Product
    Trek Kickster
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1567-2019·2019-07-24

    ADM Recalls Multiple Flour Brands Due to Potential E. coli O26 Presence

    ADM is recalling various flour products, including King Arthur and Pillsbury brands, due to the potential presence of E. coli O26.

    Product
    King Arthur All Purpose Flour 5 LB bag UPC code: 071012010509
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2019·2019-07-24

    DeRoyal Custom Surgical Packs Recalled for Sterility Barrier Defect

    DeRoyal is recalling 108 custom surgical packs in Oklahoma because they contain defective Cardinal Health Blunt Cannulas that could compromise sterility.

    Product
    DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1971-2019·2019-07-24

    Electrode Conductivity Spray Solution Recalled for Antimicrobial Testing Failures

    Pharmaceutical Innovations, Inc. is recalling ElectroMist Electrode Conductivity Spray Solution due to potential failures in stability antimicrobial effectiveness testing.

    Product
    ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2019·2019-07-24

    SpineFrontier Recalls A-CIFT SoloFuse Fixed Angle Driver Due to Binding Risk

    SpineFrontier, Inc. is recalling six A-CIFT SoloFuse Fixed Angle Drivers because they may bind when advancing fixation screws.

    Product
    A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1965-2019·2019-07-24

    GE Healthcare Recalls Two Ultrasound Systems Due to Transducer Misalignment

    GE Healthcare is recalling two ultrasound systems because transvaginal probes may be misaligned. The devices were distributed in the US and internationally.

    Product
    Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1951-2019·2019-07-24

    GE Healthcare Recalls Revolution CT Scanners Due to Radiation Exposure

    GE Healthcare is recalling Revolution CT scanners because they may expose patients to additional low-dose radiation.

    Product
    Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V545000·2019-07-24

    Mercedes-Benz Metris Recalled for Incorrect Operator's Manual

    Daimler Vans USA is recalling 2019 Mercedes-Benz Metris vehicles because the printed operator's manual may not match the vehicle's features, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1553-2019·2019-07-24

    Sprouts Farmers Market Cut Leaf Spinach Recalled for Listeria

    Sprouts Farmers Market is recalling 1,046 cases of Cut Leaf Spinach because testing revealed the presence of Listeria monocytogenes.

    Product
    Sprouts Farmers Market Cut Leaf Spinach, Net Wt 16 Oz (1 lb), 453 g, Manufactured exclusively for Sprouts Farmers Market, Phoenix, AZ UPC 8 74875 00982 2, packaged in plastic bags, 12 bags per case.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1960-2019·2019-07-24

    Zimmer Biomet Recalls Reverse Shoulder Instrument Cases Due to Sterilization Validation

    Zimmer Biomet is recalling 92 Comprehensive Reverse Shoulder Instrument Cases because they lack adequate sterilization validation. The products were distributed in the US and 16 foreign countries.

    Product
    Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1550-2019·2019-07-24

    Oregon Potato Company Recalls Frozen Red Raspberries Due to Norovirus Risk

    Oregon Potato Company is recalling 2,970 cases of frozen whole red raspberries due to potential Norovirus contamination. The product was distributed across ten western and central US states.

    Product
    Frozen whole Red Raspberries; packed in a 12 oz. polyethylene bag; UPC: 0 70552 30501 4. The label is read in parts: "***WinCo Foods Red Raspberries *** KEEP FROZEN***PRODUCT OF USA***DISTRIBUTED BY: WINCO FOODS LLC, BOISE, ID***".
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1561-2019·2019-07-24

    ADM Recalls Baker's Corner Flour Due to Potential E. coli O26 Presence

    ADM is recalling Baker's Corner All Purpose Flour because of the potential presence of E. coli O26. The product was sold at ALDI stores in 11 states.

    Product
    Baker's Corner All Purpose Flour 5 lb. bag UPC code: 041498130404
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1573-2019·2019-07-24

    ADM Recalls Dominator Flour Due to Potential E. coli O26 Presence

    ADM is recalling specific lots of Dominator Flour because of the potential presence of E. coli O26. The product was distributed in New York and Pennsylvania.

    Product
    Dominator Flour 50lb bags Product Code 745220 Lot#: 8319BF
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2019·2019-07-24

    Pharmaceutical Innovations Recalls Alpha Conducting Solution Due to Stability Testing Concerns

    Pharmaceutical Innovations, Inc. is recalling Alpha Conducting solution due to potential failures in stability antimicrobial effectiveness testing. The product was distributed in the US and internationally.

    Product
    Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V542000·2019-07-24

    Forest River Recalls 2019 Glaval and Startrans Buses for Seat Belt Bolt Issue

    Forest River is recalling 2019 Glaval and Startrans buses because driver's seat belt anchor bolts may not be fully tightened, potentially causing the seat belt to fail in a crash.

    Product
    GLAVAL BUS — GLAVAL BUS, STARTRANS COMMUTE, PRIMETIME, CONCORDE II, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1575-2019·2019-07-24

    ADM Recalls Flour Products Due to Potential E. coli O26 Presence

    ADM is recalling specific lots of flour products due to the potential presence of E. coli O26. The affected products were distributed to retailers and commercial bakeries in multiple states.

    Product
    Commander Flour Enr, Mt Bulk Product Code 704020
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1566-2019·2019-07-24

    ADM Recalls Multiple Flour Brands Due to Potential E. coli O26 Presence

    ADM is recalling various flour products, including Pillsbury BEST Bread Flour, due to the potential presence of E. coli O26.

    Product
    Pillsbury BEST Bread Flour Enriched 5 LB bag UPC code: 051500200315
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2019·2019-07-24

    Zimmer Biomet Recalls Reverse Shoulder Instrument Cases Due to Sterilization Validation

    Zimmer Biomet is recalling 1,257 Comprehensive Reverse Shoulder Instrument Cases because they lack adequate sterilization validation. The products were distributed in the US and 16 foreign countries.

    Product
    Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V549000·2019-07-24

    Thomas Built Buses Recall Roof Escape Hatch Handle Defect

    Daimler Trucks North America is recalling specific Thomas Built Buses because the roof escape hatch handle may break, preventing emergency exit.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER HDX, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2019·2019-07-24

    BD Microtainer Tubes Recalled Due to Reduced Anticoagulant Additive

    Becton Dickinson is recalling specific Microtainer tubes because they may contain reduced or no additive, causing blood samples to clot and delaying test results.

    Product
    BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the foll
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1986-2019·2019-07-24

    Clariance Erisma-LP Posterior Fixation System Recalled for Screw Disassembly Risk

    Clariance Inc is recalling Erisma-LP posterior fixation system components due to a potential for polyaxial screws to disassemble during implantation.

    Product
    Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrenc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1577-2019·2019-07-24

    ADM Bulk Flour Recalled for Potential E. coli O26 Contamination

    ADM is recalling specific lots of bulk flour due to the potential presence of E. coli O26. The product was distributed to commercial bakeries and food service providers in several states.

    Product
    Dominator Bl, En, Br, Mt Bulk Flour Product Code 745060
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1608-2019·2019-07-24

    Kroger Stuffed Mushrooms Recalled for Undeclared Soy Allergen

    GH Foods is recalling Kroger Stuffed Mushrooms because the product contains soy, which is not declared on the label.

    Product
    Kroger Stuffed Mushrooms; Net Wt. 7 oz. (193 g) over-wrapped tray Perishable, Keep Refrigerated. Cook before consumption UPC: 2676614086 Distributed by Renaissance Food Group, LLC. 1730 Eastbridge Ave. Riverside, CA 92507
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1985-2019·2019-07-24

    DJO Aircast Sterile Cuff Recall Due to Sterility Concerns

    DJO, LLC is recalling 9 units of Aircast REF 3011 sterile cuffs because they may not meet sterility requirements.

    Product
    Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1940-2019·2019-07-24

    Datascope Cardiosave Rescue IABP Recalled for Battery Maintenance Issues

    Datascope Corp. is recalling 6,197 Cardiosave Rescue IABP units because improper battery maintenance may result in less than minimum operating power.

    Product
    Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2019·2019-07-24

    Olympus Mobile Workstations Recalled for Potential Instability

    Olympus is recalling WM-NP2 and WM-DP2 mobile workstations because the control panel arm may cause the unit to fall over if a heavy monitor is attached.

    Product
    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1579-2019·2019-07-24

    ADM Bulk Flour Recalled for Potential E. coli O26 Presence

    ADM is recalling Maple T-43 En Nobl Bulk Flour due to potential E. coli O26 contamination. The product was distributed to bakeries and retailers in multiple states.

    Product
    Maple T-43 En Nobl Bulk Flour Product Code 803038
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1572-2019·2019-07-24

    ADM Recalls Latina Niagra Flour Due to Potential E. coli O26 Presence

    ADM is recalling specific lots of Latina Niagra Flour due to the potential presence of E. coli O26. Consumers should check their pantry for the affected product code and lot number.

    Product
    Latina Niagra Flour 50lbs bags Product Code 845202 Lot#: 8344BF
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1565-2019·2019-07-24

    ADM Recalls Multiple Flour Brands Due to Potential E. coli O26 Presence

    ADM is recalling various flour products, including Pillsbury and King Arthur brands, due to the potential presence of E. coli O26.

    Product
    Pillsbury POTENTATE HIGH GLUTEN FLOUR BLEACHED BROMATED ENRICHED 50 LB bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1574-2019·2019-07-24

    ADM Recalls Special Flour Bulk Product Due to E. coli O26 Risk

    ADM is recalling GWB Special Flour Bulk Product Code 803011 due to the potential presence of E. coli O26. The product was distributed to retailers and commercial bakeries in multiple states.

    Product
    GWB Special Flour Bulk Product Code 803011
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2019·2019-07-24

    Pharmaceutical Innovations Recalls ElectroMist Electrode Conductivity Spray Solution

    Pharmaceutical Innovations, Inc. is recalling ElectroMist electrode conductivity spray solution due to potential failure in antimicrobial effectiveness testing.

    Product
    ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2019·2019-07-24

    Medline Recalls Anti-Fog Solution in Surgical Kits Due to Degradation

    Medline Industries is recalling 14,550 units of anti-fog solution in surgical kits because the chemical properties may have degraded, preventing proper defogging.

    Product
    Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1982-2019·2019-07-24

    Beckman Coulter Recalls Kaluza C Flow Cytometry Software Due to Compatibility Issues

    Beckman Coulter is recalling Kaluza C Flow Cytometry Software because compatibility issues with Microsoft Windows updates render the software unusable, potentially delaying the reporting of results.

    Product
    Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educati
    Category
    Medical Device
    Distribution
    2 states

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