The Recall Desk

Archive

October 2020 recalls

622 recalls were announced in October 2020.

What the numbers show

Critical
84
Severe
123
High
313
Moderate
83
Low
19

Of the 622 recalls this month scored against our rubric, 14% are Critical, 20% are Severe.

301–400 of 622

  • HighFDA (Food)·F-0085-2021·2020-10-21

    Seasonal Blend products recalled due to potential Listeria monocytogenes contamination

    The FDA is recalling Seasonal Blend products because they have the potential to be contaminated with Listeria monocytogenes.

    Product
    Seasonal Blend 10oz UPC 68113118048; Seasonal Blend 16oz UPC 681131180498; Seasonal Blend 32oz UPC 681131180504 all packaged in clear plastic containers
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0105-2021·2020-10-21

    Cook Inc. Recalls Percutaneous Neonatal Pigtail Nephrostomy Sets

    Cook Inc. is recalling 368 Percutaneous Neonatal Pigtail Nephrostomy Sets because the indwell time is decreasing from 4 months to 4 weeks.

    Product
    Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0098-2021·2020-10-21

    Smart Care Hand Sanitizer Recall Due to Misleading Packaging Resembling Food and Drink

    The FDA is recalling Smart Care hand sanitizers because their container packaging is designed to look like food and drink pouches, potentially confusing consumers.

    Product
    Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144,
    Category
    Consumer Product
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0106-2021·2020-10-21

    Cook Inc. Recalls Pediatric Nephrostomy Stent Sets Due to Labeling Update

    Cook Inc. is recalling 380 Pediatric Nephrostomy Stent Sets because the indwell time is decreasing from 4 months to 4 weeks. The Instructions for Use are being updated to reflect this change.

    Product
    Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcoc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0107-2021·2020-10-21

    Ezycare Disposable Face Masks Recalled for Mislabeling as Non-Medical

    FDA is recalling Ezycare disposable face masks because they were labeled as non-medical but distributed to customers expecting medical use.

    Product
    Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0034-2021·2020-10-21

    Leadiant Recalls Subpotent Cystaran Ophthalmic Solution

    Leadiant Biosciences is recalling 1,380 bottles of Cystaran ophthalmic solution because testing found decreased levels of the active ingredient.

    Product
    CYSTARAN — CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0093-2021·2020-10-21

    Biomet Shoulder Prosthesis Baseplate Packaging Error Recall

    Biomet is recalling 3 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates due to packaging errors where components may be missing or duplicated.

    Product
    Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0014-2021·2020-10-21

    J.R. Simplot Recalls Trader Joe's Potato Tots for Foreign Material

    J.R. Simplot is recalling Trader Joe's Trader Potato Tots due to the potential presence of small pieces of plastic or rubber material.

    Product
    TRADER JOE S TRADER POTATO TOTS is frozen potatoes, SKU # 94904, retail bag has net wt. 2 lbs. Product is packaged in plastic bag. TRADER JOE S TRADER POTATO TOTS, master case is labeled as 0094 9040, frozen potatoes. There are 18/2 lbs. bags per case. The retail label is
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0092-2021·2020-10-21

    Getinge Servo-i Ventilator Recall for Short Nebulizer Connector

    Getinge is recalling 431 Servo-i Ventilators because a nebulizer connector may be shorter than specified, potentially preventing the Aeroneb Nebulizer module from installing successfully.

    Product
    Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for N
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-0103-2021·2020-10-21

    Roche Recalls Tina-quant Complement C4 Reagents Due to Quality Issues

    Roche Diagnostics is recalling 180 units of Tina-quant Complement C4 reagents due to cross-contamination causing invalid calibrations.

    Product
    Tina-quant Complement C4 ver.2, Catalog 05991994190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0104-2021·2020-10-21

    Roche Recalls Albumin Gen.2 Reagents Due to Cross-Contamination

    Roche Diagnostics is recalling Albumin Gen.2 reagents due to cross-contamination causing low quality recovery and invalid calibrations.

    Product
    Albumin Gen.2, Catalog 05166861190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V646000·2020-10-19

    Mitsubishi Fuso Trucks Recalled for Loose Exhaust Studs and Fire Risk

    Mitsubishi Fuso is recalling 2019-2021 FEC7T, FEC9T, and FECZT trucks because loose exhaust studs may allow hot gases to leak, increasing fire risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC7T, FEC9T, FECZT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V644000·2020-10-19

    Audi Recalls One 2020 Q3 for Driver's Seat Frame Bolt Defect

    Audi is recalling one 2020 Q3 because the driver's seat frame may be incorrectly bolted to the seat rail, increasing injury risk in a crash.

    Product
    AUDI — AUDI Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V645000·2020-10-19

    Mitsubishi Fuso Trucks Recalled for Brake Booster Vacuum Pump Defect

    Mitsubishi Fuso is recalling 2019-2021 FEC7T, FEC9T, and FECZT trucks because heat from the exhaust manifold may crack the brake booster vacuum pump diaphragm, potentially disabling power brake assist.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC7T, FEC9T, FECZT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·025-2020·2020-10-17

    Taher Inc. Recalls Meat Products Produced Without Federal Inspection

    Taher, Inc. is recalling approximately 22,096 pounds of frozen meat products produced without federal inspection. The products were shipped to institutions and food service locations in Minnesota.

    Product
    Taher, Inc. — Taher, Inc. Recalls Meat Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·20E079000·2020-10-17

    Fuel Delivery Module Recall Due to Potential Stalling Risk

    Continental Automotive Systems is recalling Vitesco NG2 Fuel Delivery Modules where a plastic burr may block the mixing tube, causing insufficient fuel supply and vehicle stalling.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E078000·2020-10-16

    Weldon V-Mux Vista IV LCD Displays Recalled for Electrical Lockup

    Akron Brass is recalling Weldon V-Mux Vista IV LCD displays used in emergency vehicles because they may lock up due to voltage spikes, potentially delaying emergency efforts.

    Product
    ELECTRICAL SYSTEM: INSTRUMENT CLUSTER/PANEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V639000·2020-10-15

    GM Recalls 2020 SUVs for Fuel Pump Defect Causing Engine Stalls

    General Motors is recalling 2,781 2020 Buick, Cadillac, Chevrolet, and GMC SUVs because a fuel pump defect may cause the engine to stall without warning.

    Product
    CADILLAC — CADILLAC, BUICK, CHEVROLET XT5, XT6, ENCLAVE, TRAVERSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V582000·2020-10-15

    Prime-Time Recalls 2014-2019 Ram ProMaster Paratransit Vehicles

    Prime-Time Specialty Vehicles is recalling 2014-2019 Ram ProMaster Paratransit vehicles because the transmission shifter cable may disconnect, causing unintended movement.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V637000·2020-10-15

    Genie Recalls 2020 TZ-34 and TZ-50 Trailer-Mounted Boom Lifts

    Genie is recalling 2020 TZ-34 and TZ-50 trailer-mounted boom lifts because under-tightened bolts may affect stability and increase injury risk.

    Product
    GENIE — GENIE TZ-50, TZ-34
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V638000·2020-10-15

    GM Recalls 2014-2016 Chevrolet SS and Caprice PPV for Seat Belt Defect

    General Motors is recalling 1,788 vehicles because a previous repair may have been improper, causing the driver's seat belt tensioner cable to fatigue and separate.

    Product
    CHEVROLET — CHEVROLET CHEVEROLET SS, CAPRICE POLICE PURSUIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21703·2020-10-15

    Homerygardens Extension Cord Splitters Recalled for Fire Hazard

    Sales BSD is recalling Homerygardens extension cord splitters because the wire size cannot handle the appropriate amp load, posing a fire hazard.

    Product
    Homerygardens™ 4-Outlet, 6-Foot Long Indoor and Outdoor Extension Cord Splitters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21702·2020-10-15

    Peloton Recalls PR70P Bike Pedals Due to Laceration Hazard

    Peloton is recalling PR70P clip-in pedals fitted on bikes sold between July 2013 and May 2016 because they can break unexpectedly, causing laceration injuries.

    Product
    PR70P Clip-In Pedals fitted on Peloton bikes (sold between July 2013 and May 2016)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0004-2021·2020-10-14

    Tim Campbell Farm Flat Parsley Recalled for Listeria monocytogenes

    Tim Campbell Farm LLC is recalling flat parsley in wooden crates because the product tested positive for Listeria monocytogenes.

    Product
    Tim Campbell Farm flat parsley in wooden crate. Neither Net weight nor quantity stated on label; product is 30 count.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0085-2021·2020-10-14

    Roche BenchMark ULTRA Advanced Staining System Recalled for Electrical Fire Risk

    Roche Diagnostics is recalling BenchMark ULTRA Advanced Staining Systems due to a risk of fluid leaks causing electrical shorts, heat, and fire.

    Product
    BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0082-2021·2020-10-14

    Biomet OnPoint Scope Procedure Kit Recalled for Sterilization Defect

    Biomet is recalling OnPoint Scope Procedure Kits because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0059-2021·2020-10-14

    AB ULAX 1500 Flex Heat and Moisture Exchanger Recall for Disconnection Risk

    AB ULAX is recalling 1500 Flex Heat and Moisture Exchangers because they may disconnect from the respiratory circuit, potentially causing hypoxia or death.

    Product
    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0086-2021·2020-10-14

    Roche Discovery Ultra Staining System Recalled for Electrical Short Risk

    Roche Diagnostics is recalling the DISCOVERY ULTRA Advanced Staining System due to fluid leaks that can cause electrical shorts, heat, and smoke.

    Product
    DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V631000·2020-10-14

    Mercedes-Benz Recalls 2020 Sprinter Vans Due to Brake Hose Defect

    Daimler Vans USA is recalling 2020 Mercedes-Benz Sprinter vans because damaged brake hoses may leak fluid, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 2500, SPRINTER 1500, SPRINTER 4500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0018-2021·2020-10-14

    Direct Rx Recalls Losartan Potassium 100 mg Tablets Due to Impurity

    Direct Rx is recalling 33 bottles of Losartan Potassium 100 mg tablets found to contain an impurity above acceptable levels.

    Product
    Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0017-2021·2020-10-14

    Direct Rx Recalls Ranitidine 300 mg Tablets Due to NDMA Impurity

    Direct Rx is recalling 26 bottles of Ranitidine 300 mg tablets because the product was found to contain the NDMA impurity.

    Product
    Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0016-2021·2020-10-14

    Direct Rx Recalls Ranitidine 150 mg Tablets Due to NDMA Impurity

    Direct Rx is recalling specific lots of Ranitidine 150 mg tablets because an NDMA impurity was detected. The affected products were distributed in Florida and Georgia.

    Product
    Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0005-2021·2020-10-14

    PD-Rx Recalls Nature-Throid Tablets Due to CGMP Deviations and Sub-Potency Risk

    PD-Rx Pharmaceuticals is recalling 20 bottles of Nature-Throid 1 GR tablets due to CGMP deviations and potential sub-potency. The product was distributed in Arizona and Oklahoma.

    Product
    Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-0005-2021·2020-10-14

    Kalustyan Recalls Ground Cinnamon Due to Possible Salmonella Contamination

    Kalustyan Corp. is recalling bulk ground cinnamon due to possible Salmonella contamination. The product was distributed in the US and to foreign facilities.

    Product
    Ground cinnamon. Packaged in bulk 50 lb. corrugated boxes with inside liner.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0079-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0066-2021·2020-10-14

    Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability

    Medline Industries is recalling 32 non-sterile cath lab kits because they were sold to accounts without the capability to sterilize them prior to use.

    Product
    Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2021·2020-10-14

    Luminex VERIGENE Processor SP Recalled for Heater Failure

    Luminex is recalling one VERIGENE Processor SP system in Missouri due to a hybridization heater failure that may cause incorrect test results.

    Product
    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0051-2021·2020-10-14

    Ansell Microflex Diamond Grip Examination Gloves Recalled for Barrier Integrity Verification

    Ansell Healthcare Products LLC is recalling Microflex Diamond Grip Examination Gloves because they were shipped without verification of barrier integrity.

    Product
    MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2021·2020-10-14

    Nuvasive Precice Bone Transport System Recall for Distal Plug Disassociation Risk

    Nuvasive is recalling 41 Precice Bone Transport System units because standard removal tools can cause the distal plug to disassociate during explantation.

    Product
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0063-2021·2020-10-14

    Medline Recalls Non-Sterile Radiology Kits Sold Without Sterilization Capability

    Medline Industries is recalling 20 non-sterile radiology kits that were sold to accounts without the ability to sterilize them prior to use.

    Product
    Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufact
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0064-2021·2020-10-14

    Medline Recalls Non-Sterile MTO Protection Station Plus Kits

    Medline is recalling 80 non-sterile MTO Protection Station Plus kits because they were sold to facilities without sterilization capabilities.

    Product
    Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2021·2020-10-14

    Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

    Medline is recalling 16 non-sterile left heart kits sold to accounts without sterilization capabilities. The kits require sterilization prior to use.

    Product
    Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2021·2020-10-14

    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Recalled for Sterilization Defect

    Biomet, Inc. is recalling ONPOINT SCOPE PROCEDURE KIT-EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0081-2021·2020-10-14

    Biomet Regenerex Primary Taper Cap Recalled for Sterilization Defect

    Biomet is recalling Regenerex Primary Taper Caps because they were not properly aligned for gamma sterilization, potentially leaving them unsterilized.

    Product
    Biomet Regenerex Primary Taper Cap Item Number 141269
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0058-2021·2020-10-14

    Medline Recalls ClearPro Closed Suction Catheters Due to Assembly Separation

    Medline Industries is recalling 6,225 ClearPro Closed Suction Catheters because the catheter may separate from the device assembly during use.

    Product
    ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·20V634000·2020-10-14

    Commercial trucks recalled for incorrect axle weight rating labels

    Daimler Trucks North America is recalling approximately 53 units of 2020-2021 Western Star and Freightliner commercial trucks due to incorrect Gross Axle Weight Rating information on vehicle certification labels. This could lead to axle overloading and increased crash risk.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 4700, 4900, 108SD, 114SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2021·2020-10-14

    Medline Recalls Non-Sterile Vascular Surgery Kits Sold Without Sterilization Capability

    Medline Industries is recalling 80 non-sterile vascular surgery kits sold to accounts without sterilization capabilities. The kits were distributed nationwide, including in CA, CO, CT, OH, TX, and NY.

    Product
    Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2021·2020-10-14

    Medline Recalls Quick Release Gait Belts Due to Buckle Breakage Risk

    Medline Industries is recalling 13,500 Quick Release Gait Belts because the buckle may break due to material degradation from gamma radiation exposure.

    Product
    Quick Release Gait Belt, 60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0073-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments

    Biomet 3i, LLC is recalling BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.

    Product
    BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0084-2021·2020-10-14

    Biomet ARTHROSIMPLICITY KIT EU Recalled Due to Sterilization Defect

    Biomet is recalling ARTHROSIMPLICITY KIT EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2021·2020-10-14

    Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability

    Medline Industries is recalling 16 non-sterile cath lab kits that were sold to accounts without the ability to sterilize them prior to use.

    Product
    Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and man
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2021·2020-10-14

    DJO EMPOWR Tibial Knee Punch Handle Recall Due to Retaining Pin Risk

    Encore Medical is recalling 190 units of DJO EMPOWR Tibial Knee Punch Handles because the retaining pin may fall out, potentially leaving debris in the joint space.

    Product
    DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0028-2021·2020-10-14

    Tampa Bay Fisheries Recalls Taco Seasoned Salmon for Undeclared Soy

    Tampa Bay Fisheries is recalling Taco Seasoned Salmon products due to undeclared soy. The recall affects 75 cases distributed in San Antonio, Texas.

    Product
    Meal Simple Taco Seasoned Salmon Over Fire Roasted Vegetables and Grains, Net WT. 10.8 oz (306g), Use By Date of 2020-9-24.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0050-2021·2020-10-14

    Ra Medical Systems Recalls DABRA RA-308 Excimer Laser Units

    Ra Medical Systems is recalling 54 DABRA RA-308 Excimer Laser units because a taller wheel mounting may cause the device to fall over, potentially injuring users or patients.

    Product
    DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0008-2021·2020-10-14

    Advanced Spice Recalls Ground Cinnamon for Potential Salmonella Contamination

    Advanced Spice & Trading, Inc. is recalling 7,400 pounds of Ground Cinnamon 2% (CASSIA) in 50-pound bags due to potential Salmonella contamination. The product was distributed in Texas.

    Product
    Ground Cinnamon 2% (CASSIA) packaged in 50 pound bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0061-2021·2020-10-14

    Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

    Medline Industries is recalling 60 non-sterile Left Heart Kits sold to accounts without sterilization capabilities. The kits were distributed nationwide.

    Product
    Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V633000·2020-10-14

    Toyota Recalls 2020 Highlanders Due to Seat Airbag Deployment Risk

    Toyota is recalling 2020 Highlander and Highlander Hybrid vehicles because incorrect seat trim covers may prevent side airbags from deploying properly, increasing injury risk in a crash.

    Product
    TOYOTA — TOYOTA HIGHLANDER, HIGHLANDER HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2021·2020-10-14

    Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

    Medline Industries is recalling 16 non-sterile Left Heart Kits sold to facilities without sterilization capabilities. The kits were intended to be sterilized prior to use.

    Product
    Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0012-2021·2020-10-14

    Nettle Meadow Truffle Fromage Frais Recalled Due to Pasteurization Record Failure

    LuMaZu, LLC dba Nettle Meadow is recalling 16 units of Truffle Fromage Frais because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Truffle Fromage Frais***Contains pasteurized goat and cows milk*** 5 oz."
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0053-2021·2020-10-14

    Ultradent PermaFlo Flowable Composite Recalled for Manufacturing Cross-Contamination

    Ultradent Products, Inc. is recalling PermaFlo Flowable Composite due to a potential manufacturing issue causing cross-contamination and non-homogeneity.

    Product
    PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2021·2020-10-14

    Bard Conquest PTA Balloon Catheter Recalled for Incorrect Balloon Size

    Bard Peripheral Vascular Inc is recalling 281 units of the Conquest PTA Balloon Dilation Catheter because some units contain a 5mm balloon instead of the labeled 6mm size.

    Product
    Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0009-2021·2020-10-14

    Nettle Meadow Fig Honey Fromage Frais Recalled for Pasteurization Record Failure

    LuMaZu, LLC dba Nettle Meadow is recalling Fig Honey Fromage Frais because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Fig Honey Fromage Frais*** Contains pasteurized goat and cows milk*** 5 oz.***"
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0010-2021·2020-10-14

    Calvin Scott Recalls Diethylpropion Tablets Due to Missing Stability Studies

    Calvin Scott & Company is recalling specific lots of Diethylpropion 75 mg tablets because they were repackaged without supporting stability studies.

    Product
    Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0011-2021·2020-10-14

    Calvin Scott Recalls Phentermine Capsules Due to Stability Study Deviations

    Calvin Scott & Company is recalling specific lots of Phentermine 30 mg capsules because they were repackaged without supporting stability studies.

    Product
    Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0076-2021·2020-10-14

    Biomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 4 units of BellaTek abutments because the hex was misaligned by 30 degrees, preventing correct placement in patients.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0052-2021·2020-10-14

    Siemens Troponin I Reagent Cartridge Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Dimension LOCI High Sensitivity Troponin I reagent cartridges due to positive bias in test results.

    Product
    Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0071-2021·2020-10-14

    Skytron VGA to Fiber Converter Recall for Video Signal Failure

    Skytron is recalling 11 VGA to Fiber Converter units for the SkyVision Linx 300 system due to faceplate failures that cause video signal loss on secondary displays.

    Product
    VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0056-2021·2020-10-14

    Brainlab Ultrasound Navigation Software Recalled for Image Width Limitation

    Brainlab AG is recalling Ultrasound Navigation Software 1.0 and related integration software because the system does not support modifying the probe's image width.

    Product
    Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0009-2021·2020-10-14

    Calvin Scott Recalls Diethylpropion Tablets Due to Stability Deviations

    Calvin Scott & Company is recalling specific lots of Diethylpropion 25 mg tablets because they were repackaged without supporting stability studies.

    Product
    Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0074-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.

    Product
    BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0075-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Dental Abutments

    Biomet 3i is recalling 9 units of BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0077-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 35 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Food)·F-0030-2021·2020-10-14

    Skippy Super Chunk Peanut Butter Recalled for Aflatoxin Levels

    Hormel Foods is recalling Skippy Super Chunk Peanut Butter because aflatoxin levels were slightly above the actionable limit.

    Product
    SKIPPY Super Chunk Peanut Butter 16.3oz UPC: 00037600110723 packaged in non-flexible plastic container
    Category
    Food
    Distribution
    35 states
  • ModerateFDA (Food)·F-0013-2021·2020-10-14

    Nettle Meadow Artisan Cheese Recalled Due to Unrecorded Pasteurization Temperature

    LuMaZu, LLC dba Nettle Meadow is recalling two cases of Habanero Peach Fromage Frais because pasteurization temperatures were not recorded due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Habanero Peach Fromage Frais***Contains pasteurized goat and cows milk*** 5 oz."
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0010-2021·2020-10-14

    Nettle Meadow Apple Cider Fromage Frais Recalled Due to Pasteurization Record Failure

    LuMaZu, LLC dba Nettle Meadow is recalling 5 oz. Apple Cider Fromage Frais because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese ***Apple Cider Fromage Frais*** Contains pasteurized goat and cows milk*** 5 oz."
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0078-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 10 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Food)·F-0011-2021·2020-10-14

    Nettle Meadow Artisan Cheese Recalled Due to Pasteurization Recording Failure

    LuMaZu, LLC dba Nettle Meadow is recalling artisan cheese because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.

    Product
    "Nettle Meadow Artisan Cheese *** Roasted Red Pepper Fromage Frais***Contains pasteurized goat and cows milk***5 oz."
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0057-2021·2020-10-14

    Zimmer Biomet Recalls Dual Mobility Vivacit-E Bearing Due to Sizing Error

    Zimmer Biomet is recalling 31 Dual Mobility Vivacit-E bearings because the outer package label indicates a different size than the implant inside.

    Product
    Dual Mobility Vivacit-E Bearing, Model Number 110031009
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Drugs)·D-0019-2021·2020-10-14

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity

    VistaPharm is recalling Nystatin Oral Suspension because one lot failed impurity specifications. The affected product was distributed nationwide.

    Product
    NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0070-2021·2020-10-14

    Devicor Neoprobe GDS Control Unit Recalled for Software Version Mismatch

    Devicor Medical Products Inc is recalling 49 Neoprobe GDS Control Units distributed to China because the installed software version does not match the approved version.

    Product
    Neoprobe GDS Control Unit, Model Number NPCU3
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0015-2021·2020-10-14

    Pharmaceutical Associates Recalls Citalopram Oral Solution Due to Impurities

    Pharmaceutical Associates Inc. is recalling Citalopram Oral Solution due to high impurity levels found during stability testing.

    Product
    Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·20E077000·2020-10-13

    Diode Dynamics Recalls SL1 LED Headlamp Bulbs for Excessive Glare

    Diode Dynamics is recalling specific SL1 LED headlamp bulbs that exceed brightness standards and may cause glare to oncoming drivers, increasing crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V629000·2020-10-12

    Utilimaster Walk-In Van Recall for Throttle Pedal Interference

    Shyft Group is recalling 2020 Utilimaster Walk-In vans because the throttle pedal may get trapped by the floor tread plate, increasing crash risk.

    Product
    UTILIMASTER — UTILIMASTER WALK-IN VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V626000·2020-10-09

    Mercedes-Benz Recalls 2020 GLE and GLS Models for Grounding Defect

    Mercedes-Benz is recalling 2020 GLE and GLS models because a faulty electrical ground connection may cause power steering, wiper, or headlight malfunctions.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450, GLS 450, GLS 580 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V627000·2020-10-09

    Mercedes-Benz Recalls 2020 GLE 350 for Driveshaft Installation Defect

    Mercedes-Benz is recalling two 2020 GLE 350 vehicles because the driveshaft locking ring may not be installed correctly, potentially causing a loss of power transfer and vehicle stall.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-10092020-01·2020-10-09

    Taylor Farms Recalls Ready-to-Eat Spaghetti Squash Bowls Due to Glass Contamination

    USDA FSIS issued a public health alert for Taylor Farms ready-to-eat spaghetti squash bowls produced in October 2020 due to possible glass contamination.

    Product
    Taylor Farms TX, Inc. — FSIS Issues Public Health Alert for Ready-To-Eat Meat and Poultry Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·20V625000·2020-10-09

    Toro Recalls 2017-2020 Log Splitters Due to Tow Pole Mounting Plate Defect

    The Toro Company is recalling 2017-2020 model 22618 and 22618HD Log Splitters because tow pole mounting plates could bend, causing bolts to break and increasing crash risk.

    Product
    TORO — TORO LOG SPLITTER
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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