The Recall Desk

Archive

September 2019 recalls

454 recalls were announced in September 2019.

What the numbers show

Critical
36
Severe
124
High
216
Moderate
64
Low
14

Of the 454 recalls this month scored against our rubric, 8% are Critical, 27% are Severe.

301–400 of 454

  • HighFDA (Devices)·Z-2476-2019·2019-09-11

    Roche cobas e 601 Module Recalled for Inaccurate Results

    Roche Diagnostics is recalling cobas e 601 modules due to a quality issue with high pressure solenoid valves that may cause inaccurate test results.

    Product
    cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2477-2019·2019-09-11

    Roche Recalls Cobas 8000 Analyzer Modules Due to Valve Quality Issue

    Roche Diagnostics is recalling 19 Cobas 8000 Modular Analyzer Series units due to a quality issue with high pressure solenoid valves.

    Product
    Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2466-2019·2019-09-11

    B. Braun Medical Recalls Espocan Spinal/Epidural Trial Needles

    B. Braun Medical is recalling 100 units of Espocan Spinal/Epidural Trial Needles because damage to the filter membrane prevents the filter from achieving its intended capacity.

    Product
    ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2471-2019·2019-09-11

    B. Braun Medical Recalls Con Epi Tray Due to Filter Membrane Damage

    B. Braun Medical is recalling 200 units of Con Epi Trays because damage to the filter membrane prevents the device from achieving its required filter capacity.

    Product
    CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2474-2019·2019-09-11

    B. Braun Medical Recalls Cont. Epidural Needles Due to Filter Damage

    B. Braun Medical is recalling 1,230 units of CE18TKSTN Cont. Epidural Needles because the filter membrane is damaged, preventing the device from achieving its intended filter capacity.

    Product
    CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-2104-2019·2019-09-11

    Vitony Bakery Guava Cheese Cake Roll Recalled for Allergen Mislabeling

    Vitony Bakery is recalling Guava Cheese Cake Rolls because the packaging failed to declare soy and specific food dyes, and lacked refrigeration instructions.

    Product
    Vitony Bakery, Brazo Gitano Guayaba Queso (Guava- Cheese Cake Roll); Peso Neto 12 ONZ. (340 G)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2096-2019·2019-09-11

    Mountain Mel's Diges-Teas Herbal Tea Recalled for Salmonella Contamination

    Mountain Mel's Essential Goods LLC is recalling Diges-Teas Herbal Tea due to potential Salmonella contamination. The product was distributed in California, Oregon, and Washington.

    Product
    Diges-Teas Herbal Tea, packaged loose leaf in aluminum tin, net weight 2 oz or 56.5 grams. UPC: 7 99632 05665 2. The label is read in parts: "***Diges-Teas ***CAFFEINE-FREE HERBAL TEA*** Mountain Mels Essential Goods, LLC Welches, OR 97067***Supplement Facts***Fennel*** Direct
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2101-2019·2019-09-11

    Schrock's Sugar 'N Spice Recalls Maple Iced Cinnamon Rolls for Undeclared Walnuts

    Schrock's Sugar 'N Spice LLC is recalling Maple Iced Cinnamon Rolls because they contain undeclared walnuts. The product was sold in one store in West Virginia and one in Ohio.

    Product
    Maple Iced Cinnamon Rolls, Net Wt. 1.33 lbs., Walnuts on top in see-through clamshells with clear plastic lids. 8 rolls per clamshell.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2107-2019·2019-09-11

    Nice! Espresso Trail Mix Recalled for Undeclared Sulfites

    Suntree Snack Foods is recalling Nice! Espresso Trail Mix because it contains undeclared sulfites, a common allergen.

    Product
    Nice! Espresso Trail Mix, Net Wt 2.5 Oz (70g) Pouch. Distributed by Sun Tree Snack Foods, LLC, Ambient Storage
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2439-2019·2019-09-11

    BD Kiestra InoqulA+ Software Version 20.3 Recalled for Specimen Mismatch Risk

    Becton Dickinson & Co. is recalling 9 units of BD Kiestra InoqulA+ Software Version 20.3 due to an anomaly that may cause specimen and plate mismatches.

    Product
    BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2472-2019·2019-09-11

    B. Braun Medical Recalls Accu-Bloc Perifix Kits Due to Filter Damage

    B. Braun Medical is recalling 3,820 units of Accu-Bloc Perifix Kits because damage to the filter membrane prevents the device from achieving its intended filter capacity.

    Product
    CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2438-2019·2019-09-11

    BD Kiestra InoqulA Software Version 20.3.IVD Recalled for Specimen Mismatch Risk

    Becton Dickinson & Co. is recalling 4 units of BD Kiestra InoqulA Software Version 20.3.IVD due to an anomaly that may cause specimen and plate mismatches.

    Product
    BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2356-2019·2019-09-11

    Norm-O-Temp 111W Medical Device Recalled for Missing Tissue Damage Warning

    Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111W units because the manual lacks instructions warning that exceeding 40 Celsius for extended periods can cause tissue damage.

    Product
    Norm-O-Temp model 111W
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2473-2019·2019-09-11

    B. Braun Medical Recalls Accu-Bloc Perifix Kits Due to Filter Damage

    B. Braun Medical is recalling 200 units of Accu-Bloc Perifix Kits because damaged filter membranes may prevent the device from achieving required filter capacity.

    Product
    CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2468-2019·2019-09-11

    B. Braun Recalls FEF 100N Flat Epidural Filters Due to Membrane Damage

    B. Braun Medical is recalling 250 units of FEF 100N Flat Epidural Filters because damage to the filter membrane prevents the device from achieving its intended filter capacity.

    Product
    FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2467-2019·2019-09-11

    B. Braun Recalls Spinal and Epidural Trays Due to Filter Damage

    B. Braun Medical is recalling 200 units of spinal and epidural trays because the filter membrane is damaged, preventing the device from achieving required filter capacity.

    Product
    ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2436-2019·2019-09-11

    Coltene Recalls Diatech Diamond Dental Burs Due to Length Variations

    Coltene is recalling a specific lot of Diatech diamond dental burs because the instruments in the batch vary in length despite having the same shape and grit.

    Product
    DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2434-2019·2019-09-11

    Helena Laboratories Recalls Titan Gel Serum Protein Control Kits

    Helena Laboratories is recalling 65 kits of Titan Gel Serum Protein Control due to customer complaints about a narrow assay range.

    Product
    Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-2105-2019·2019-09-11

    Vitony Bakery Cheese-Guava Pudding Cake Recalled for Undeclared Dyes

    Vitony Bakery is recalling 2,354 units of Cheese-Guava Pudding Cake because the product fails to declare FD&C Yellow #5 and FD&C Yellow #6.

    Product
    Vitony Bakery, Bizcocho de Queso y Guayaba (Cheese-Guava Pudding Cake); Peso Neto 14 ONZ. (397 G)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2448-2019·2019-09-11

    LeMaitre Aortic Occlusion Catheter Recalled for Incorrect Size Labeling

    LeMaitre Vascular is recalling 62 units of Aortic Occlusion Catheters because the packaging lists the incorrect device size.

    Product
    The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall th
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2095-2019·2019-09-11

    Lipton Diet Iced Peach Tea Recalled for Undeclared Ingredients

    Pepsi Bottling Ventures is recalling Lipton Diet Iced Peach Tea bottles due to undeclared Malic Acid and Citrus Pectin.

    Product
    Lipton DIET ICED TEA PEACH 6/16.9 oz plastic bottles MANUFACTURED BY INDEPENDENT PRODUCERS FOR THE PEPSI/LIPTON TEA PARTNERSHIP, PURCHASE, NY 10577
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2102-2019·2019-09-11

    Southern Style Mfg Recalls Sweet and Sour Products for Undeclared Yellow 5

    Southern Style Mfg is recalling Dolce Piquant and Freshmo Sweet and Sour products due to undeclared Yellow 5 dye. The recall covers 2,700 gallons distributed in Texas and California.

    Product
    Dolce Piquant Sweet and Sour 3 gallon (384 Fl OZ) and Freshmo Sweet and Sour in 3 gallon (384 Fl OZ)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2441-2019·2019-09-11

    Fujifilm FDR Go Plus X-ray System Recalled for Software Glitch

    Fujifilm is recalling 174 FDR Go Plus mobile X-ray systems because a graphics driver issue may cause the device to display a Blue Screen of Death.

    Product
    Fujifilm FDR Go Plus mobile X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2443-2019·2019-09-11

    CareFusion Alaris EtCO2 Capnographs Recalled for Calibration Error

    CareFusion 303, Inc. is recalling 76 Alaris EtCO2 capnographs because they may have been calibrated with a lower-than-specified CO2 concentration.

    Product
    Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2447-2019·2019-09-11

    Karl Storz Flexible Intubation Fiberscopes Recalled for Manufacturing Defect

    Karl Storz Endoscopy is recalling 14 Flexible Intubation Fiberscopes because they were improperly manufactured with a double port luer instead of a single port luer.

    Product
    Flexible Intubation Fiberscope, Model # 11301AB1
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2442-2019·2019-09-11

    Boston Scientific Recalls Mislabeled AMS 800 Artificial Urinary Sphincter Cuffs

    Boston Scientific is recalling AMS 800 Artificial Urinary Sphincter belt cuffs labeled as 4.5 cm but measuring 4.0 cm due to mislabeling.

    Product
    AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2482-2019·2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900 Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900 operating microscopes because a software error in the floor stand's central control unit may affect device function.

    Product
    HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS H
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2450-2019·2019-09-11

    SonarMed AirWave Monitor Recalled Due to Potential Error Codes

    SonarMed Inc is recalling 16 AirWave Monitor units because two error codes may render the devices inoperable.

    Product
    SonarMed AirWave Monitor, Model Number M0001
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2445-2019·2019-09-11

    Roche Tina-Quant Myoglobin Gen. 2 Assay Recalled for QC Imprecision

    Roche is recalling Tina-Quant Myoglobin Gen. 2 assays due to signal drops causing calibration failures and QC imprecision on specific analyzers.

    Product
    The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2484-2019·2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900A Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900A operating microscopes and specific floor stands due to a software error in the central control unit.

    Product
    HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2437-2019·2019-09-11

    Heidelberg SPECTRALIS Ophthalmic Imaging Device Recalled for Data Display Error

    Heidelberg Engineering is recalling 29 SPECTRALIS ophthalmic imaging devices because a software configuration error may cause incorrect display of patient master data.

    Product
    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2433-2019·2019-09-11

    Getinge CO2 Absorber Recalled for Reversed Expiration and Manufacturing Dates

    Getinge is recalling 1,444 boxes of disposable CO2 absorbers because the expiration and manufacturing dates on the labels are reversed.

    Product
    Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2475-2019·2019-09-11

    Alere Cholestech LDX Analyzer Recalled for Reversed Power Supply Polarity

    Alere San Diego, Inc. is recalling 186 Alere Cholestech LDX Analyzer kits because the power supplies have reversed polarity, rendering the devices inoperable.

    Product
    Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2444-2019·2019-09-11

    AngioDynamics VenaCure EVLT NeverTouch Procedure Kit Recalled for RFID Error

    AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because an RFID programming error prevents the product from being used with the laser source.

    Product
    AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
    Category
    Medical Device
    Distribution
    8 states
  • SevereUSDA FSIS·091-2019·2019-09-10

    Hy-Vee Recalls Ready-to-Eat Beef and Chicken for Undeclared Milk

    Hy-Vee Fresh Commissary is recalling ready-to-eat beef and chicken products because they contain undeclared milk, a known allergen.

    Product
    HY-VEE FRESH COMMISSARY — Hy-Vee Fresh Commissary Recalls Ready-To-Eat Beef and Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    8 states
  • HighCPSC·19204·2019-09-10

    Ragdoll & Rockets Recalls Children's Loungewear for Flammability Violation

    Ragdoll & Rockets is recalling about 14,100 units of children's loungewear because the items fail to meet federal flammability standards for sleepwear, posing a risk of burn injuries.

    Product
    Children's loungewear
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19200·2019-09-10

    Healing Solutions Recalls Essential Oils for Child-Resistant Packaging Failure

    Healing Solutions is recalling Wintergreen and Birch essential oils because the bottles lack required child-resistant caps, posing a poisoning risk to young children.

    Product
    Healing Solutions Wintergreen and Birch 100 percent Pure Therapeutic Grade Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19203·2019-09-10

    DIANA Stormrider Gen 2 Air Rifles Recalled for Unexpected Discharge Risk

    DIANA is recalling Stormrider Gen 2 air rifles because they can unexpectedly discharge even when the safety is engaged, posing a risk of serious injury or death.

    Product
    DIANA® Stormrider Gen 2 Air Rifles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V647000·2019-09-09

    Isuzu Recalls 2017-2019 Trucks for Potential Electrical Wiring Defect

    Isuzu is recalling 2017-2019 N-Series and Chevrolet Low Cab Forward trucks because a loose bolt in the relay box may cause electrical failure and vehicle stalling.

    Product
    CHEVROLET — CHEVROLET, ISUZU LOW CAB FORWARD 6500, LOW CAB FORWARD 4500, LOW CAB FORWARD 3500, N-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V648000·2019-09-09

    Mercedes-Benz Recalls 2020 GLE Models for Missing Head Restraint Manual Info

    Mercedes-Benz is recalling 2020 GLE 350 and GLE 450 vehicles because the owner's manuals lack instructions for adjusting third-row head restraints, violating federal safety standards.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V643000·2019-09-06

    GM Recalls 2020 Buick Enclave and Chevrolet Traverse for Frame Rail Crack

    General Motors is recalling 2020 Buick Enclave and Chevrolet Traverse vehicles because a crack in the right-hand frame rail may reduce crash performance and increase injury risk.

    Product
    BUICK — BUICK, CHEVROLET ENCLAVE, TRAVERSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E060000·2019-09-06

    TAP Recalls Pro Comp Lug Nuts Due to Incorrect Sizing

    TAP Worldwide is recalling 840 Pro Comp Extended Thread lug nuts that may be incorrectly sized. The defect could prevent proper tightening, leading to lug stud failure and increased crash risk.

    Product
    WHEELS:LUGS/NUTS/BOLTS/STUDS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V645000·2019-09-06

    GM Recalls Trucks and SUVs for Brake Vacuum Pump Defect

    General Motors is recalling 2014-2018 Chevrolet, GMC, and Cadillac vehicles because a vacuum pump defect may reduce brake assist, increasing stopping distance.

    Product
    CHEVROLET — CHEVROLET, GMC, CADILLAC SUBURBAN, SILVERADO 1500, SIERRA 1500, YUKON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V646000·2019-09-06

    Temsa Recalls Buses Due to Inadequate Emergency Exit Window Labels

    Temsa is recalling 2013-2020 TS35C, TS35E, and TS45 buses because emergency exit window labels may not clearly describe how to open them quickly.

    Product
    TEMSA — TEMSA TS35C, TS45, TS35E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V642000·2019-09-06

    GM Recalls 2018 Chevrolet Malibus Due to Engine Software Error

    General Motors is recalling 2018 Chevrolet Malibus with 1.5L turbo engines because a software error may disable fuel injectors, causing the engine to stall.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V644000·2019-09-06

    GM Recalls 2019 Chevrolet Express and GMC Savana for Seatbelt Warning Defect

    General Motors is recalling 2019 Chevrolet Express and GMC Savana vehicles because the seatbelt-unfastened warning light may fail to illuminate for five seconds after ignition.

    Product
    GMC — GMC, CHEVROLET SAVANA, EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·090-2019·2019-09-05

    BCI Foods Recalls Meat and Poultry Soup Products Lacking Import Inspection

    BCI Foods is recalling approximately 3,304 pounds of meat and poultry soup products that were imported without the required USDA inspection.

    Product
    BCI Foods Inc. Recalls Meat and Poultry Soup Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·19202·2019-09-05

    MOMO Quick Release Steering Wheel Adapters Recalled for Crash Hazard

    MW Company is recalling MOMO Quick Release Steering Wheel Adapters for race cars because the quick release mechanism can activate inadvertently, causing the steering wheel to detach and posing a crash hazard.

    Product
    MOMO Quick Release Steering Wheel Adapters for Race Cars
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19201·2019-09-05

    STIHL PolyCut Mowing Heads Recalled Due to Injury Hazard

    STIHL is recalling about 73,000 PolyCut mowing heads because loose bolts can cause the unit to come apart, posing an injury risk.

    Product
    STIHL PolyCut ™ Mowing Heads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19779·2019-09-05

    Walker Edison Recalls Children's Bunk Beds Due to Fall Hazards

    Walker Edison Furniture is recalling about 1,200 children's bunk beds because support boards can break, posing fall and injury hazards.

    Product
    Children's bunk beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2093-2019·2019-09-04

    FDA Recalls Fresh Basil Tested Positive for Salmonella

    Harvest Sensations, LLC is recalling fresh basil that tested positive for Salmonella. The product was imported from Mexico and distributed in New York.

    Product
    Fresh basil packaged in plastic bags, each weighing one pound. (No label)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2094-2019·2019-09-04

    AWERS Grained Salmon Caviar Recalled for Potential Botulism Contamination

    AWERS Inc is recalling Grained Salmon Caviar due to potential Clostridium botulinum contamination. Consumers should check their refrigerators for the specific product details.

    Product
    Grained Salmon Caviar 95g (Sockeye Salmon Caviar), refrigerated, packed in a metal tin with Cyrillic lettering. The tin is green, with red and white writing with an easy open pull lid. UPC 8 85202 00044 3. The label is read in parts: "***GRAINED SALMON CAVIAR ***INGREDIENTS:
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2386-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc. is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801741012228
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-2367-2019·2019-09-04

    Siemens Artis X-Ray Systems Recalled for Patient Table Cracks

    Siemens is recalling 17 Artis zee and Artis Q interventional X-ray systems because cracks in the patient table mainframe could cause the upper bed to detach, posing a hazard to patients and staff.

    Product
    Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2378-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Drugs)·D-1845-2019·2019-09-04

    Pfizer Recalls Relpax Tablets Due to Microbial Contamination

    Pfizer is recalling specific lots of Relpax (eletriptan HBr) tablets because they may be contaminated with Burkholderia and Pseudomonas bacteria.

    Product
    RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2089-2019·2019-09-04

    Confectionery Arts International Recalls Jewel Dust Pearlescent Pigment

    Confectionery Arts International is recalling Jewel Dust pearlescent pigment because borosilicate glass material was found in an FDA sample.

    Product
    All colors and sizes of Confectionery Arts International, LLC brand Jewel Dust, a pearlescent pigment, manufactured and sold prior to 4/25/19; 4g packed in 1/4 oz. jars and 14g packed in 1 oz. jars.
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-2392-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recall Due to Tip Damage

    Bard Peripheral Vascular Inc is recalling 887 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801741012310
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2364-2019·2019-09-04

    CooperSurgical Recalls TransWarmer Infant Mattresses Due to Burn Risk

    CooperSurgical is recalling TransWarmer Warming Infant Transport Mattresses because some units lack updated instructions prohibiting use with other heat devices, which could cause skin burns.

    Product
    TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104 (whe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc is recalling Equistream XK hemodialysis catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2368-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling Equistream Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2403-2019·2019-09-04

    Siemens SOMATOM go.All CT Scanner Injector Holder Recall

    Siemens Medical Solutions is recalling SOMATOM go.All CT scanners because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2019·2019-09-04

    Siemens SOMATOM go.Top CT Scanner Recall for Falling Injector Holder

    Siemens is recalling SOMATOM go.Top CT scanners because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2019·2019-09-04

    Siemens SOMATOM go.Top CT Scanner Recall for Falling Injector Holder

    Siemens is recalling 12 SOMATOM go.Top CT scanners because the injector holder could fall off. The devices are distributed in 20 US states.

    Product
    SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2394-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 39 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 00801741012334
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2118-2019·2019-09-04

    Olive Bakery Chestnut Bread Recalled for Undeclared Wheat Allergen

    Olive Bakery is recalling chestnut bread packages because the label declares flour but fails to declare wheat, a major food allergen.

    Product
    Chestnut bread packages contain two bread pastries filled with white bean paste filling and topped with sesame seeds on the outside. Product does NOT contain any chestnut. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritiona
    Category
    Food
    Distribution
    2 states
  • HighCPSC·19199·2019-09-04

    Artizen Oils Recalls Wintergreen and Birch Essential Oils for Packaging Defect

    Artizen Oils is recalling wintergreen and birch essential oils because the bottles lack required child-resistant caps, posing a poisoning risk to young children.

    Product
    Artizen Oils Wintergreen and Birch 100 percent Pure & Natural Therapeutic Grade Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recall for Tip Defects

    Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801741013850
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2383-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 00801741012174
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2381-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Defect

    Bard Peripheral Vascular Inc is recalling 2 units of Equistream XK hemodialysis catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2389-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 104 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2390-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2419-2019·2019-09-04

    Stryker Endintrak 2 Hook Blade Recall Due to Compromised Sterile Seal

    Stryker GmbH is recalling 76 units of the Endintrak 2 Hook Blade because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2019·2019-09-04

    Abbott Recalls Alinity ci Series System Control Modules Due to Software Error

    Abbott is recalling Alinity ci series System Control Modules because a software issue may cause incorrect test results after a system stop.

    Product
    Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Defect

    Bard Peripheral Vascular Inc is recalling 13 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2395-2019·2019-09-04

    Bard Hemodialysis Catheter Recalled Due to Molded Tip Breakage

    Bard Peripheral Vascular Inc is recalling 140 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2373-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recall Due to Tip Breakage

    Bard Peripheral Vascular Inc is recalling 161 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013713
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2384-2019·2019-09-04

    Bard Hemodialysis Catheter Recalled for Molded Tip Breakage During Placement

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during the placement procedure.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2393-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 91 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801741012327
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2370-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc is recalling 40 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2401-2019·2019-09-04

    Siemens SOMATOM go.Up CT Systems Recalled for Falling Injector Holder

    Siemens is recalling three SOMATOM go.Up CT systems because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2019·2019-09-04

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling 49 Monaco Radiation Treatment Planning Systems because software errors display and export incorrect anatomy and beam shift directions.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2361-2019·2019-09-04

    Roche Elecsys Anti-CCP Immunoassay Recalled Due to Performance Issues

    Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.

    Product
    Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2422-2019·2019-09-04

    Stryker Endotrac EPF/EGR Triangle Blade Recall for Compromised Sterile Seal

    Stryker GmbH is recalling 21 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, posing a risk of contamination.

    Product
    Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2369-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 135 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2391-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2112-2019·2019-09-04

    Olive Bakery Peanut Crunch Bread Recalled for Wheat Labeling Error

    Olive Bakery is recalling five packages of Peanut Crunch bread because the label declares flour but fails to declare wheat, a major allergen.

    Product
    Peanut Crunch bread packages contain two bread pastries with no filling and topped with a peanut butter crunch on the outside. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. Th
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2109-2019·2019-09-04

    Olive Bakery Red Bean Bread Recalled for Wheat Mislabeling

    Olive Bakery is recalling 41 packages of Red Bean Bread because the label lists flour but fails to declare wheat, a major allergen.

    Product
    Red Bean bread package contains two bread pastries filled with red bean paste filling, packaged in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing label and reads in part
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2388-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 570 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2371-2019·2019-09-04

    Bard Hemodialysis Catheter Recalled Due to Tip Breakage During Placement

    Bard Peripheral Vascular Inc is recalling 1,356 EQUISTREAM Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during the placement procedure.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2120-2019·2019-09-04

    Olive Bakery Recalls Red Bean and Walnut Bread for Allergen Mislabeling

    Olive Bakery is recalling three packages of red bean and walnut bread sold in Oregon and Washington due to undeclared wheat and walnut allergens.

    Product
    Red/ Walnut bread packages contain two bread pastries filled with red bean paste filling coated with egg on the outside and topped with walnuts. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included o
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2116-2019·2019-09-04

    Olive Bakery Cream Horns Recalled for Undeclared Wheat and Soy Allergens

    Olive Bakery is recalling Cream Horns because the label fails to declare wheat and soy lecithin, posing a risk to consumers with allergies.

    Product
    Cream Horns packages contain one bread pastry filled with non-dairy whipped cream filling. Product is packaged in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing label
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2387-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2375-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Defects

    Bard Peripheral Vascular Inc is recalling 39 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013775
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2385-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 00801741012198
    Category
    Medical Device
    Distribution
    53 states

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