The Recall Desk

Archive

January 2020 recalls

534 recalls were announced in January 2020.

What the numbers show

Critical
40
Severe
215
High
178
Moderate
85
Low
16

Of the 534 recalls this month scored against our rubric, 7% are Critical, 40% are Severe.

1–100 of 534

  • SevereNHTSA·20V060000·2020-01-31

    McElrath Trailers Recalls 2016-2020 Models Due to Frame Weld Cracks

    McElrath Trailers is recalling 2016-2020 VX30-800 and VX50-800 trailers because structural frame welds may crack, increasing crash risk.

    Product
    MCELRATH TRAILERS — MCELRATH TRAILERS VX30-800, VX50-800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V056000·2020-01-31

    Volkswagen Recalls Audi Vehicles for Driver Air Bag Inflator Defect

    Volkswagen Group of America is recalling specific Audi A8, A4, TT, and A6 models because driver air bag inflators may absorb moisture, potentially causing improper deployment in a crash.

    Product
    AUDI — AUDI A8, A4, TT, A6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V057000·2020-01-31

    Volkswagen Recalls 2018 Atlas Vehicles Due to Air Bag Sensor Defect

    Volkswagen is recalling 2018 Atlas vehicles because an incorrectly manufactured air bag sensor may delay or disable deployment, increasing injury risk in crashes.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V054000·2020-01-31

    Triple E Recalls 2020 Motorhomes Due to Propane Line Defects

    Triple E is recalling 237 2020 Unity, Wonder, and Serenity motorhomes because twisted or kinked propane lines may leak and cause a fire.

    Product
    WONDER — WONDER, UNITY, SERENITY W24FTB, W24RTB, W24MB, U24MB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V055000·2020-01-30

    GM Recalls 2019 Silverado and Sierra Trucks for Brake Software Error

    General Motors is recalling 2019 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because a software error may disable electronic brake assist, increasing crash risk.

    Product
    GMC — GMC, CHEVROLET SIERRA 1500, SILVERADO 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V053000·2020-01-30

    Land Rover Recalls 2020 Discovery Models for Seat Frame Defect

    Jaguar Land Rover is recalling 2020 Discovery vehicles because second-row seat frames may lack fasteners, potentially failing to secure occupants in a crash.

    Product
    LAND ROVER — LAND ROVER DISCOVERY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20714·2020-01-30

    Polaris Recalls 2019 Pro XD Utility Vehicles Due to Rear Brake Failure Risk

    Polaris is recalling about 760 Model Year 2019 Pro XD utility vehicles because the rear brake line can puncture, causing rear brake failure and posing a crash hazard.

    Product
    Model Year 2019 Polaris PRO XD Utility Vehicles (UTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20713·2020-01-30

    Polaris Recalls 2017-2018 Brutus UTVs Due to Rear Brake Line Failure

    Polaris is recalling 2017-2018 Brutus utility vehicles because a rear brake line can puncture, causing brake failure and a crash hazard.

    Product
    Model Year 2017-2018 Brutus Utility Vehicles (UTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20716·2020-01-30

    K-Apparel Recalls Children's Lounge Pants Due to Burn Hazard

    K-Apparel is recalling about 2,200 TINFL children's lounge pants because they fail federal flammability standards, posing a burn risk to children.

    Product
    Children's Lounge Pants
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·005-2020·2020-01-29

    Banquet Pepperoni Stuffed Pizza Sandwiches Recalled for Undeclared Soy

    Astrochef LLC is recalling Banquet pepperoni stuffed pizza sandwiches due to misbranding and undeclared soy, a known allergen.

    Product
    Pegasus Foods Inc. — Astrochef LLC. Recalls Pepperoni Stuffed Pizza Sandwich Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V049000·2020-01-29

    Forest River Recalls 2020 Recreational Trailers Due to Brake Switch Failure

    Forest River is recalling 218 units of 2020 recreational trailers because a failed break-away switch may prevent brakes from engaging if the trailer separates from the tow vehicle.

    Product
    FOREST RIVER — FOREST RIVER FREEDOM EXPRESS, WILDCAT MAXX, WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0800-2020·2020-01-29

    Entropic Labs SARM RAD-140 Recalled for Lack of FDA Approval

    Entropic Labs is recalling SARM RAD-140 capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0793-2020·2020-01-29

    Ranitidine Tablets Recalled Due to NDMA Impurity Detection

    H.J. Harkins Company is recalling specific lots of Ranitidine 150 mg tablets because NDMA impurity was detected. The product was distributed to physicians in four states.

    Product
    Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-0525-2020·2020-01-29

    AQUABEST Sea Mart Frozen Yellowfin Tuna Recalled for Histamine Levels

    AQUABEST SEAFOOD LLC is recalling Sea Mart Frozen Yellowfin Tuna Saku due to potentially elevated histamine levels linked to a recent poisoning outbreak.

    Product
    Sea Mart Frozen Yellowfin Tuna Saku, CO treated, skinless, boneless, bloodline removed, 10-12oz, 10 lb package
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0842-2020·2020-01-29

    Palodex Dental X-Ray Imagers Recalled for Power Supply Fire Risk

    Palodex Group Oy is recalling Instrumentarium Dental Express X-ray imagers because slow degradation of plastic insulation in the power supply unit may cause short circuits, heating, and smoke.

    Product
    Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0794-2020·2020-01-29

    Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity

    Denton Pharma is recalling 1,341 bottles of Ranitidine Tablets 150 mg because the product was found to contain the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0524-2020·2020-01-29

    AQUABEST Seafood Recalls Frozen Yellowfin Tuna Loin Due to Histamines

    AQUABEST SEAFOOD LLC is recalling 9,630 lbs of Sea Mart Frozen Yellowfin Tuna Loin due to potentially elevated histamine levels linked to a recent poisoning outbreak.

    Product
    Sea Mart Frozen Yellowfin Tuna Loin, CO treated, skinless, boneless, bloodline removed, center cut 5-8 lbs, 30 lb package
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0523-2020·2020-01-29

    Sea Mart Frozen Yellowfin Tuna Steak Recalled for Histamine Levels

    AQUABEST SEAFOOD LLC is recalling Sea Mart Frozen Yellowfin Tuna Steak due to potentially elevated histamine levels linked to a poisoning outbreak.

    Product
    Sea Mart Frozen Yellowfin Tuna Steak, CO treated, skinless, boneless, bloodline removed, 8 oz, 10lb package
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0796-2020·2020-01-29

    Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

    Preferred Pharmaceuticals is recalling 150 mg Ranitidine tablets because of detected NDMA impurity. The affected products were distributed to physicians in seven states.

    Product
    Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0835-2020·2020-01-29

    Polymer Technology Systems Recalls CardioChek Plus Analyzers Due to Battery Overheating Risk

    Polymer Technology Systems is recalling 44,448 CardioChek Plus Professional Analyzers because a battery terminal defect can cause reverse contact and potential overheating.

    Product
    Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0841-2020·2020-01-29

    KaVo Scan eXam X-Ray Imager Recalled for Power Supply Fire Risk

    Palodex Group Oy is recalling KaVo Scan eXam X-ray imagers because plastic insulation degradation in the power supply may cause short circuits, heating, and smoke.

    Product
    KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0795-2020·2020-01-29

    Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity

    Denton Pharma is recalling 467 bottles of Ranitidine Tablets 300 mg because of the presence of NDMA impurity. The affected products were distributed nationwide.

    Product
    Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0791-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 150 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·20V050000·2020-01-29

    Vactor 2100i Vehicles Recalled for Safety Interlock Software Defect

    Vactor is recalling 2017-2020 2100i vehicles because a software defect may cause safety interlocks to fail, leading to unintentional vehicle movement and increased crash risk.

    Product
    VACTOR — VACTOR 2100I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0798-2020·2020-01-29

    RemedyRepack Recalls Ranitidine Tablets Due to Potential NDMA Contamination

    RemedyRepack Inc. is recalling specific lots of Ranitidine 150 mg tablets because the supplier reported potential Nitrosodimethylamine (NDMA) levels above established limits.

    Product
    Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0792-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 300 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0797-2020·2020-01-29

    Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

    Preferred Pharmaceuticals is recalling Ranitidine Tablets, 300 mg, because the presence of the NDMA impurity was detected in the product.

    Product
    Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0819-2020·2020-01-29

    GE Healthcare Recalls Centricity Universal Viewer 6.0 for Measurement Errors

    GE Healthcare is recalling Centricity Universal Viewer 6.0 because incorrect measurements in DICOM files may lead to potential misdiagnosis.

    Product
    Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0555-2020·2020-01-29

    Savannah Classics Cornbread Dressing Recalled for Listeria Risk

    Savannah Food Company is recalling Savannah Classics Special Cornbread Dressing because eggs used in manufacturing may be contaminated with Listeria monocytogenes.

    Product
    Savannah Classics Special Cornbread Dressing packaged in 7lb trays
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0813-2020·2020-01-29

    GE Healthcare Recalls Carestation Anesthesia Systems Due to Loose Cable Connection

    GE Healthcare is recalling 3,319 Carestation anesthesia systems worldwide due to a potential loose cable connection that could cause loss of mechanical ventilation.

    Product
    Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2020·2020-01-29

    PTS Diagnostics CardioChek Plus Analyzer Recalled for Battery Overheating Risk

    Polymer Technology Systems is recalling 44,448 refurbished CardioChek Plus Professional Analyzers because a battery terminal defect may cause overheating if batteries are inserted incorrectly.

    Product
    PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2020·2020-01-29

    Isopure Centrifugal Pump Recall Due to Magnet Encapsulation Defect

    Isopure Corp is recalling eight Finish Thompson Centrifugal Pumps due to a manufacturing defect that could expose magnets to solution, causing corrosion and iron contamination.

    Product
    Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0814-2020·2020-01-29

    GE Healthcare Recalls Carestation Anesthesia Systems Due to Loose Cable Risk

    GE Healthcare is recalling 280 Carestation anesthesia systems worldwide due to a potential loose cable connection that could cause a loss of mechanical ventilation.

    Product
    Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2020·2020-01-29

    PTS Diagnostics CardioChek Plus Analyzer Recalled for Battery Overheating Risk

    Polymer Technology Systems is recalling 44,448 CardioChek Plus Professional Analyzers because a battery terminal defect can cause overheating if batteries are inserted incorrectly.

    Product
    PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0840-2020·2020-01-29

    Gendex X-Ray Imager Recall Due to Power Supply Insulation Degradation

    Palodex Group Oy is recalling Gendex GXPS-500 X-ray imagers because plastic insulation in the power supply may degrade, causing short circuits, heating, and smoke.

    Product
    Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0556-2020·2020-01-29

    Savannah Classics Cornbread Dressing Recalled for Listeria Risk

    Savannah Food Company is recalling Savannah Classics Classic Cornbread Dressing because eggs used in manufacturing may be contaminated with Listeria monocytogenes.

    Product
    Savannah Classics Classic Cornbread Dressing packaged in 7lb trays
    Category
    Food
    Distribution
    9 states
  • HighCPSC·20059·2020-01-29

    Summer Infant Recalls SwaddleMe Inclined Sleepers Due to Suffocation Risk

    Summer Infant is recalling about 46,300 SwaddleMe By Your Bed inclined sleepers to prevent the risk of infant suffocation. Consumers should stop using the product immediately and contact the company for a refund.

    Product
    SwaddleMe By Your Bed Sleeper inclined sleeper
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20062·2020-01-29

    Graco Recalls Little Lounger Rocking Seats to Prevent Suffocation Risk

    Graco is recalling Little Lounger Rocking Seats to prevent the risk of infant suffocation. Consumers should stop using the product and contact Graco for a refund.

    Product
    Graco Little Lounger Rocking Seat
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0839-2020·2020-01-29

    Soredex DIGORA Optime X-Ray Imager PSU Insulation Recall

    Palodex Group Oy is recalling 297 Soredex DIGORA Optime X-ray imagers because plastic insulation in the power supply may degrade, causing short circuits, heating, and smoke.

    Product
    Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0530-2020·2020-01-29

    ASK Foods Recalls Jonah Crab Meat Stuffing Due to Listeria

    ASK Foods Inc is recalling Jonah Crab Meat Stuffing because the cheese ingredient tested positive for Listeria monocytogenes.

    Product
    Jonah Crab Meat Stuffing 5 lb. (2.27 kg) Bulk Plastic Container,6 - 5 lb. containers per case , Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·20V051000·2020-01-29

    KME Predator Emergency Vehicles Recalled for Flashlight Battery Explosion Risk

    Kovatch Mobile Equipment is recalling specific KME Predator emergency vehicles because flashlight battery packs may explode while charging, increasing injury risk.

    Product
    KME — KME PREDATOR SS AERIAL, PREDATOR SS PUMPER, PREDATOR SS TDA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0838-2020·2020-01-29

    Imactis Navigation Kit Recalled for Potential Microbial Contamination

    Imactis is recalling 122 Navigation Kits because the sensor cover may contain microbial contamination, posing a risk of pyrogenic response.

    Product
    Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx On
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0553-2020·2020-01-29

    Morrison's Cornbread Dressing Recalled for Listeria Risk

    Savannah Food Company is recalling Morrison's cornbread dressing because eggs used in manufacturing may be contaminated with Listeria monocytogenes.

    Product
    Morrison's cornbread dressing packaged in 4lb tray
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0557-2020·2020-01-29

    Savannah Classics Bread Stuffing Recalled for Listeria Risk

    Savannah Food Company is recalling Savannah Classics Classic Bread Stuffing because eggs used in manufacturing may be contaminated with Listeria monocytogenes.

    Product
    Savannah Classics Classic Bread Stuffing packaged in 4.5lb trays
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0822-2020·2020-01-29

    Isopure Sodium Bicarbonate Mixing System Recalled for Magnet Encapsulation Defect

    Isopure Corp is recalling one IsoMix PRO system due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.

    Product
    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0830-2020·2020-01-29

    Siemens ADVIA Centaur Folate Test Kits Recalled for Potential Interference

    Siemens is recalling ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.

    Product
    Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0529-2020·2020-01-29

    Belle Mar Stuffing Recalled Due to Listeria Monocytogenes Contamination

    ASK Foods Inc is recalling Belle Mar Stuffing because a cheese ingredient tested positive for Listeria monocytogenes.

    Product
    Belle Mar Stuffing 5 lb. (2.27 kg) Bulk Plastic Container,6 - 5 lb. containers per case , Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0527-2020·2020-01-29

    Pike Place Smoked Salmon Chowder Recalled for Gluten Mislabeling

    Northwest Gourmet Food Products Inc. is recalling Pike Place Smoked Salmon Chowder because the outer packaging claims 'Gluten Free' while the inner pouch declares wheat.

    Product
    Smoked Salmon Chowder, Pike Place Chowder brand, item #89201, distributed By PPC Trading Co. M. BOX #262 4580 Klahanie Drive SE Issaquah WA 98029. There are 16/16 oz. retail packages per master case. Retail package net wt. 16 oz. UPC 8 56112 00406 7. The 16 oz. inner indi
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0843-2020·2020-01-29

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Analyzers

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Analyzers because a software issue may prevent specific gravity flags, potentially leading to erroneous test results.

    Product
    iChem VELOCITY Urine Chemistry Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0821-2020·2020-01-29

    Isopure Acidified Concentrate Distribution System Recalled for Magnet Defect

    Isopure Corp is recalling 15 Acidified Concentrate Distribution and Storage Systems due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.

    Product
    Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0554-2020·2020-01-29

    Morrison's Cornbread Dressing Recalled for Listeria Risk

    Savannah Food Company is recalling Morrison's cornbread dressing because eggs used in manufacturing may be contaminated with Listeria monocytogenes.

    Product
    Morrison's cornbread dressing packaged in 7lb trays
    Category
    Food
    Distribution
    9 states
  • HighCPSC·20061·2020-01-29

    Delta Recalls Incline Sleepers for Newborns Due to Suffocation Risk

    Delta Enterprise Corp. is recalling about 5,900 incline sleepers for newborns to prevent the risk of suffocation. Consumers should stop using the products immediately.

    Product
    Beautyrest Beginnings Incline Sleeper with Adjustable Feeding Position for Newborns; Disney Baby Minnie Mouse Incline Sleeper with Adjustable Feeding Position for Newborns; Delta Children Deluxe 3-in-1 Activity Rocker, Feeder and Sleeper; Simmons Kids Beautyrest Deluxe 3-in-1 Act
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0836-2020·2020-01-29

    Paltop Dental Implant Recall Due to Incorrect Cover Screw Packaging

    Paltop Advanced Dental Solutions is recalling 67 dental implants because some were packaged with the wrong cover screw, preventing proper fit.

    Product
    Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0844-2020·2020-01-29

    Arrow Arterial Catherization Kit Recalled for Incorrect MR Labeling

    Arrow International is recalling 80 kits due to a lidstock label error that displays an MR Conditional symbol instead of MR Unsafe.

    Product
    Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial ci
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0831-2020·2020-01-29

    Siemens ADVIA Centaur Folate Test Kits Recalled for Potential Cross-Reactivity

    Siemens is recalling 3,627 ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.

    Product
    Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0799-2020·2020-01-29

    FDA Recalls NETSPOT Kits Due to Defective Aluminum Cap Crimp

    Advanced Accelerator Applications USA, Inc. is recalling NETSPOT kits because the dilution buffer vial has a loose aluminum cap crimp.

    Product
    NETSPOT — NETSPOT (68GA-DOTATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0826-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling three lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0827-2020·2020-01-29

    Medicrea Pass LP Trocar K-wire Recalled for Fit Issues

    Medicrea International is recalling 30 units of Pass LP Trocar K-wires because they may not fit into conical cannulated screws.

    Product
    Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0528-2020·2020-01-29

    Pike Place Chowder Recalled for Gluten Free Labeling Error

    Northwest Gourmet Food Products Inc. is recalling Pike Place Chowder New England Clam Chowder because the outer packaging claims 'Gluten Free' while the inner pouch declares wheat.

    Product
    New England Clam Chowder, Pike Place Chowder brand, item #89200, distributed By PPC Trading Co. M. BOX #262 4580 Klahanie Drive SE Issaquah WA 98029. There are 12/16 oz. retail packages per master case. Retail package net wt. 16 oz. UPC 8 56112 00402 9. The 16 oz. inner i
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0801-2020·2020-01-29

    Hikma Recalls Methylprednisolone Sodium Succinate Injection Due to Labeling Error

    Hikma Pharmaceuticals is recalling 4,840 vials of Methylprednisolone Sodium Succinate Injection because the label incorrectly instructs healthcare professionals to reconstitute the product with 16 mL instead of 8 mL.

    Product
    METHYLPREDNISOLONE SODIUM SUCCINATE — METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0828-2020·2020-01-29

    Medicrea Pass LP Blunt K-wire Recalled for Incompatibility with Screws

    Medicrea International is recalling 190 units of Pass LP Blunt K-wires because they may not fit into Conical Cannulated Screws.

    Product
    Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0824-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0825-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling specific lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0829-2020·2020-01-29

    Siemens ADVIA Centaur Folate 100 Test Kits Recalled for Elevated Results

    Siemens is recalling 12,796 ADVIA Centaur Folate 100 test kits because homocysteine assays may cause elevated folate results.

    Product
    Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0818-2020·2020-01-29

    Greiner Bio-One Recalls Damaged Vacuette Blood Collection Tubes

    Greiner Bio-One is recalling 1,002,000 Vacuette tubes that may have cap sealing damage, potentially causing vacuum loss and improper blood volume collection.

    Product
    VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0820-2020·2020-01-29

    Koios DS Breast Software Recalled for Missing Quality Documentation

    Koios Medical is recalling 10 units of Koios DS Breast software due to insufficient documentation of required quality procedures.

    Product
    Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
    Category
    Medical Device
    Distribution
    3 states
  • HighNHTSA·20V047000·2020-01-28

    Mercedes-Benz Recalls 2019 AMG GT63 Models Due to Wiring Harness Issue

    Mercedes-Benz is recalling 2019 AMG GT63 and GT63S vehicles because a transmission wiring harness may chafe against the drive shaft, potentially causing an engine stall.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT 63, AMG GT63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V048000·2020-01-27

    Mercedes-Benz Recalls AMG Models Due to Turbocharger Oil Leak Fire Risk

    Mercedes-Benz is recalling certain 2018-2019 AMG vehicles because a turbocharger oil feed line may leak, increasing the risk of a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG E63S, AMG GT63, AMG S63, AMG GT 63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V043000·2020-01-24

    Chrysler Recalls 2019-2020 Ram 2500 and 3500 for Fire Risk

    Chrysler is recalling 2019-2020 Ram 2500 and 3500 pickups because transmission fluid leaks may contact ignition sources, increasing the risk of a fire.

    Product
    RAM — RAM 2500, 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·004-2020·2020-01-24

    Golden Pearl Trading Recalls Imported Salted Egg Fish Skin Products

    Golden Pearl Trading Corporation is recalling approximately 12,054 pounds of ready-to-eat imported salted egg fish skin products that were not presented for import re-inspection.

    Product
    Golden Pearl Trading Corporation Recalls Ready to Eat Imported Siluriformes Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    7 states
  • ModerateUSDA FSIS·003-2020·2020-01-24

    Amity Packing Recalls Raw Ground Beef Due to Plastic Contamination

    Amity Packing Company is recalling raw ground beef products that may contain clear, thin pliable plastic. No illnesses have been reported.

    Product
    Amity Packing Co. Inc. — Amity Packing Company Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·20V040000·2020-01-23

    Rosenbauer Commander Recall: Front Shocks May Separate and Damage Steering

    Rosenbauer America is recalling 2014-2019 Commander vehicles because front shocks may separate, potentially damaging the steering gear and causing a loss of power steering assist.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V037000·2020-01-23

    Keystone Recalls 2020 Crossroads Trailers Due to Wiring Fire Risk

    Keystone RV is recalling 2020 Crossroads trailers because improper WiFi wiring circuit protection may increase the risk of fire during a short circuit.

    Product
    CROSSROADS — CROSSROADS VOLANTE, HAMPTON, CAMEO, SUNSET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V038000·2020-01-23

    GM Recalls 2014-2015 Cadillac CTS-V Sport for Rear Axle Defect

    General Motors is recalling 2014-2015 Cadillac CTS-V Sport vehicles because rear-axle differential roll pins may fracture, potentially causing the driver to lose control.

    Product
    CADILLAC — CADILLAC CTS-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V036000·2020-01-23

    Ram ProMaster Recall: Transmission Shifter Cable May Disconnect

    Chrysler is recalling 2014-2019 Ram ProMaster vans because the transmission shifter cable may disconnect, causing unintended vehicle movement and crash risk.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0518-2020·2020-01-22

    Fresh Unlimited Recalls Chef Salad Kits Due to Listeria Risk

    Fresh Unlimited Inc is recalling Chef Salad Kits because eggs used in manufacturing may be contaminated with Listeria monocytogenes.

    Product
    Chef Salad Kit: 8lbs packaged in cardboard box
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0582-2020·2020-01-22

    Dierbergs Potato Salad Recalled for Listeria Risk

    Dierbergs Markets is recalling Kosher-Style Potato Salad because it was made with hardboiled eggs potentially contaminated with Listeria monocytogenes.

    Product
    Dierbergs Kitchen Kosher-Style Potato Salad, packaged in 12 OZ containers UPC 23753400000 and in bulk by pound containers UPC 23494500000
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0586-2020·2020-01-22

    Dierbergs Grilled Chicken Cobb Salad Recalled for Listeria Risk

    Dierbergs Markets is recalling 211 units of Grilled Chicken Cobb Salad because hardboiled eggs used in the product were potentially contaminated with Listeria monocytogenes.

    Product
    Dierbergs Kitchen Salad Togo Grilled Chicken Cobb Salad packaged in 10 oz containers UPC 2393393192
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0657-2020·2020-01-22

    FDA Recalls Panther Platinum 30000 Capsules for Unapproved Tadalfil Content

    Motto International Corp is recalling Panther Platinum 30000 Capsules because FDA analysis found the product contains tadalfil and was marketed without an approved NDA or ANDA.

    Product
    Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state

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