The Recall Desk

Archive

November 2019 recalls

944 recalls were announced in November 2019.

What the numbers show

Critical
50
Severe
405
High
251
Moderate
213
Low
25

Of the 944 recalls this month scored against our rubric, 5% are Critical, 43% are Severe.

Which agencies issued them

901–944 of 944

  • ModerateFDA (Devices)·Z-0235-2020·2019-11-06

    Mindray Accutorr 3 Vital Signs Monitor Recalled for Software Features

    Mindray is recalling 13 Accutorr 3 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pres
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0298-2020·2019-11-06

    Taro Recalls Ibuprofen Oral Suspension Due to Foreign Plastic Particles

    Taro Pharmaceuticals is recalling specific lots of Ibuprofen Oral Suspension USP because they may contain small particles of inert plastic material introduced during manufacturing.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0254-2020·2019-11-06

    Centurion Medical Products Recalls GRIPPER Needles in Illinois

    Centurion Medical Products Corporation is recalling GRIPPER Needles in Illinois. The recall was initiated by the supplier.

    Product
    Maintenance Flush Kit/Blood Draw Product Code: DT19335
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0261-2020·2019-11-06

    Implant Direct Scan Adapter Assembly Recalled for Incorrect Assembly

    Implant Direct is recalling 107 Scan Adapter Assemblies due to incorrect assembly that may prevent clinicians from capturing implant positions, causing patient delays.

    Product
    Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0248-2020·2019-11-06

    Caire SAROS Oxygen System Model 3000 Recalled for Power Issue

    Caire, Inc. is recalling 10 SAROS Oxygen System Model 3000 units due to an electronics control issue that prevents the device from powering on with battery power only.

    Product
    SAROS Oxygen System Model 3000
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0260-2020·2019-11-06

    Dario Blood Glucose Monitoring System App Recall for Duplicate Logging

    Labstyle Innovations is recalling the Dario Blood Glucose Monitoring System Android app versions 4.3.0-4.3.2 because it may duplicate blood glucose readings.

    Product
    Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0246-2020·2019-11-06

    FDA Recalls Thorecon Plating System Kits Due to Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0242-2020·2019-11-06

    Alto Development Recalls Thorecon Plating System Kits Due to Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0262-2020·2019-11-06

    POM Medical Recalls Procedural Oxygen Masks Due to Defective Re-breather Bags

    POM Medical LLC is recalling 5,610 procedural oxygen masks because the re-breather bag may not inflate or the oxygen line may pop off due to a clogged port.

    Product
    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, L
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0253-2020·2019-11-06

    Centurion Medical Recalls Port Full Access Tray Kits in Illinois

    Centurion Medical Products Corporation is recalling 240 Port Full Access Tray kits in Illinois due to a supplier-initiated recall of GRIPPER Needles.

    Product
    Port full Access Tray Product Code: DT19330
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0229-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0243-2020·2019-11-06

    A&E Medical Thorecon Plating System Kits Recalled for Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0226-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.

    Product
    Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling 107 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0218-2020·2019-11-06

    OrthoPediatrics Recalls Child Nail Attachment Bolts Due to Binding Risk

    OrthoPediatrics Corp is recalling 969 Child Nail Attachment Bolts because they may bind with the intramedullary nail, potentially delaying surgical procedures.

    Product
    Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instrume
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0250-2020·2019-11-06

    Cordis MAXI LD PTA Dilatation Catheter Recalled for Expired Component

    Cordis Corporation is recalling 21 units of MAXI LD PTA Dilatation Catheters because they were manufactured using an expired inner body.

    Product
    Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0245-2020·2019-11-06

    A&E Medical Thorecon Plating System Kits Recalled for Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Food)·F-0081-2020·2019-11-06

    Jack Daniels Tennessee Whiskey Cake Recalled for Potential Mold

    The Great Spirits Baking Company is recalling Jack Daniels Tennessee Whiskey Cake - Vanilla due to potential mold growth before the expiration date.

    Product
    Jack Daniels Tennessee Whiskey Cake - Vanilla - Net Wt 8 OZ (227 g), UPC: 854621004356
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0239-2020·2019-11-06

    Medtronic 2090 CareLink Programmer Recall for Inaccurate Longevity Estimates

    Medtronic is recalling 2090 CareLink Programmer units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.

    Product
    Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0166-2020·2019-11-06

    AuroMedics Recalls Ranitidine Tablets Due to Empty Bottles

    AuroMedics Pharma LLC is recalling one lot of Ranitidine Tablets USP, 150 mg, because some bottles were found to be empty.

    Product
    Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0154-2020·2019-11-06

    Nephron Recalls Succinylcholine Chloride Injection Due to Incorrect Labeling

    Nephron Pharmaceuticals is recalling 19,390 syringes of Succinylcholine Chloride Injection because of incorrect or missing lot and expiration dates.

    Product
    PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0231-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0230-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0225-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0162-2020·2019-11-06

    Sandoz Recalls Neomycin and Polymyxin B Ophthalmic Suspension for Labeling Error

    Sandoz Inc. is recalling 346,929 bottles of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension due to incorrect or missing package inserts.

    Product
    NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE — NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0161-2020·2019-11-06

    Sandoz Recalls Bimatoprost Ophthalmic Solution Due to Missing Package Insert

    Sandoz Inc is recalling Bimatoprost Ophthalmic Solution 0.03% because the package insert is incorrect or missing. The recall covers 346,929 bottles distributed nationwide.

    Product
    BIMATOPROST — BIMATOPROST (BIMATOPROST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0079-2020·2019-11-06

    Jack Daniels Tennessee Whiskey Cake Recalled for Potential Mold

    The Great Spirits Baking Company is recalling Jack Daniels Tennessee Whiskey Cake due to potential mold growth before the best-by date.

    Product
    Jack Daniels Tennessee Whiskey Cake - Chocolate - Net Wt 8 OZ (227 g), UPC: 854621004349
    Category
    Food
    Distribution
    6 states
  • LowFDA (Drugs)·D-0167-2020·2019-11-06

    Arbor Pharmaceuticals Recalls Testosterone Cypionate Injection Due to Labeling Error

    Arbor Pharmaceuticals is recalling specific lots of Testosterone Cypionate Injection because shipper cartons were mislabeled, potentially causing confusion with different vial sizes.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·19V794000·2019-11-05

    KZRV Recalls 2019-2020 Trailers With Detaching Rear Storage Racks

    KZRV is recalling 2019-2020 Connect and Sportsmen trailers because optional Rock Run rear storage racks may detach when loaded, creating a road hazard.

    Product
    KZRV — KZRV CONNECT, SPORTSMEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19C003000·2019-11-05

    Merritt Recalls Angel Guard Angel Ride Car Beds Due to Harness Defect

    Merritt Manufacturing is recalling Angel Guard Angel Ride car beds because the restraint harness may not be properly sewn, increasing injury risk in a crash.

    Product
    CHILD SEAT:HARNESS:STRAP/WEBBING recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V793000·2019-11-05

    McElrath Trailers Recalls 2014-2019 VX Models for Missing Reflectors

    McElrath Trailers is recalling 2014-2019 VX trailers because side marker LED lights may lack required reflex reflectors, reducing visibility.

    Product
    MCELRATH TRAILERS — MCELRATH TRAILERS VX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·106-2019·2019-11-04

    Cay Thi Queentrees Recalls Poultry Products Imported Without Inspection

    Cay Thi Queentrees Food USA is recalling approximately 43,848 pounds of slow-cooked black chicken products imported from Vietnam without FSIS inspection.

    Product
    Cay Thi Queentrees Food USA Recalls Poultry Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19V792000·2019-11-04

    Daimler Recalls Western Star Trucks for Detaching Vent Windows

    Daimler Trucks is recalling 2,725 Western Star 4900 and 5700 trucks because sleeper cab vent windows may detach due to improper adhesive.

    Product
    WESTERN STAR — WESTERN STAR 4900, 5700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·107-2019·2019-11-04

    Padrino Foods Recalls Beef Tamales Due to Pork Mislabeling

    Padrino Foods is recalling beef tamales labeled as beef and sirloin that contain pork. The recall affects products sold in Kansas, Louisiana, Oklahoma, and Texas.

    Product
    Padrino Foods LLC — Padrino Foods, LLC Recalls Beef Tamales Products due to Mislabeling
    Category
    Food
    Distribution
    4 states
  • HighUSDA FSIS·pha-110219-01·2019-11-02

    Raw Pork Sausage Recalled for Undeclared Sesame Allergen

    New York Style Sausage Co. issued a public health alert for raw pork bangers containing undeclared sesame seed. No illnesses have been reported.

    Product
    NEW YORK STYLE SAUSAGE CO. — FSIS Issues Public Health Alert for Raw Pork Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19V787000·2019-11-01

    Mercedes-Benz Recalls Vehicles for Emergency Call System Software Fault

    Mercedes-Benz is recalling 24,226 vehicles due to a software fault that may cause the emergency call system to relay inaccurate location data, potentially delaying emergency responders.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ GL63, C250, SL63, SL550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V788000·2019-11-01

    Mercedes-Benz Recalls Vehicles for Seat Belt Sensor Defect

    Mercedes-Benz is recalling 29,720 vehicles because front seat belts may be incorrectly detected as unfastened, potentially disabling safety features.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 450, E 300, AMG GT63, E 400
    Category
    Vehicle
    Distribution
    Distributed nationwide

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