The Recall Desk

Archive

March 2021 recalls

387 recalls were announced in March 2021.

What the numbers show

Critical
11
Severe
150
High
165
Moderate
46
Low
15

Of the 387 recalls this month scored against our rubric, 3% are Critical, 39% are Severe.

101–200 of 387

  • HighNHTSA·21V209000·2021-03-24

    2021 Western Star 4700 and Freightliner Cascadia clutch assembly recall

    Daimler Trucks North America recalls certain 2021 Western Star 4700 and Freightliner Cascadia vehicles because the clutch flange may break, causing clutch disengagement and crash risk. Dealers will replace the clutch assembly free of charge.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 4700, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V199000·2021-03-24

    2021 BMW X3 and X4 Fuel Tank Weld May Separate, Increasing Fire Risk

    BMW is recalling certain 2021 X3 and X4 vehicles due to a fuel tank weld that may fail, allowing fuel to leak and increasing fire risk. All repairs have been completed.

    Product
    BMW — BMW X3, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V208000·2021-03-24

    2021 Genesis GV80 High-Pressure Fuel Tube Recall: Fire Risk

    Hyundai is recalling certain 2021 Genesis GV80 and G80 vehicles with 2.5-liter turbo engines due to a high-pressure fuel tube that may not seal properly, potentially allowing fuel to leak and increase fire risk.

    Product
    GENESIS — GENESIS GV80, G80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2021·2021-03-24

    Cardinal Health Recalls McKesson Prevent M Needles Due to Safety Shield Defect

    Cardinal Health is recalling 108,000 McKesson Prevent M needles because the safety shield may fail to lock, posing a risk of needlestick injuries and exposure to bloodborne pathogens.

    Product
    McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 26558
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2021·2021-03-24

    Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Recalled for False Results

    Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagents because they may produce false reactive results when used with Remel M4RT Viral Transport Media.

    Product
    VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2021·2021-03-24

    Carestream Dental CS 3600 Tips Recalled for Detachment Risk

    Carestream Dental is recalling CS 3600 Single Use Normal Tips because the mirror may become detached and fall from the unit.

    Product
    Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2021·2021-03-24

    Cardinal Health Recalls Magellan Hypodermic Safety Needles Due to Locking Failure

    Cardinal Health is recalling Magellan Hypodermic Safety Needles because the safety shield may fail to lock, creating a risk of needlestick injuries and exposure to bloodborne pathogens.

    Product
    Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2021·2021-03-24

    Medtronic Pediatric Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 4 units of a pediatric cardiotomy reservoir due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2021·2021-03-24

    Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin

    Medtronic is recalling 57 units of Affinity Pixie oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and sto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2021·2021-03-24

    Medtronic Infant Tubingset Recalled for Elevated Bacterial Endotoxin Levels

    Medtronic is recalling 14 units of infant tubingsets due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy bl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2021·2021-03-24

    Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 10 units of the Affinity Pixie Cardiotomy/Venous Reservoir due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1265-2021·2021-03-24

    Philips Incisive CT System Recalled for Gantry Actuator Failure Risk

    Philips is recalling 105 Incisive CT Computed Tomography X-ray Systems because gantry actuators may fail, causing the gantry to tilt forward.

    Product
    Incisive CT Computed Tomography X-ray System Model: 728143
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0381-2021·2021-03-24

    Amazon Kitchen Avocado Chicken Salad Sandwich Recalled for Undeclared Soy

    Flying Food Group LLC is recalling Amazon Kitchen Avocado Chicken Salad Sandwiches due to undeclared soy allergen on the label.

    Product
    Amazon Kitchen, Avocado Chicken Salad Sandwich, Net Wt. 8.1 oz., Cello wrap with cardboard liner, 1 unit per package, Perishable Keep Refrigerated
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1199-2021·2021-03-24

    Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk

    Medtronic Perfusion Systems is recalling 7 units of the Custom Perfusion System because they may contain elevated levels of bacterial endotoxins, which can cause acute inflammatory responses in patients.

    Product
    Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2021·2021-03-24

    Mindray BeneVision Distributed Monitoring System Recalled for Intermittent Freezes

    Mindray is recalling 1,938 BeneVision Distributed Monitoring Systems because they may intermittently freeze, causing telemetry data to stop communicating to the central system.

    Product
    Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2021·2021-03-24

    Cordis Precise Pro RX Carotid Stent Recall for Tip Separation

    Cordis is recalling Precise Pro RX Carotid Stent implant systems because the distal tip may separate from the lumen wire.

    Product
    PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1190-2021·2021-03-24

    Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin

    Medtronic is recalling Affinity Pixie Oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses in patients.

    Product
    Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2021·2021-03-24

    Siemens HSV-2 Test Kits Recalled for Potential False Positive Results

    Siemens is recalling ADVIA Centaur4P Herpes-2 IgG test kits due to stability and calibration failures that may cause false positive results.

    Product
    Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1253-2021·2021-03-24

    Siemens SOMATOM CT Software Recall for Workflow Interruptions

    Siemens is recalling specific software versions for SOMATOM CT systems due to sporadic errors that may interrupt scanning workflows and delay diagnosis.

    Product
    Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2021·2021-03-24

    Canon Medical Recalls Catheterization Tables Due to Potential Tilt Hazard

    Canon Medical System is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because loose bolts may cause the table to tilt.

    Product
    Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lowe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0344-2021·2021-03-24

    Minnesota Milk Bank Recalls Pasteurized Donor Human Milk

    Minnesota Milk Bank for Babies is recalling specific batches of pasteurized donor human milk due to potential trace amounts of dextromethorphan.

    Product
    MN Milk Bank for Babies Pasteurized Donor Human Milk. Volumne 4.0 fl oz., 120 mL
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1255-2021·2021-03-24

    R&D Systems Recalls Quantikine IVD Human sTfR Immunoassay Kits

    R&D Systems is recalling 156 Quantikine IVD Human sTfR Immunoassay kits due to low standard signals and out-of-specification controls.

    Product
    Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0304-2021·2021-03-24

    Spironolactone Tablets Recalled Due to Potential Labeling Mix-Up

    Bryant Ranch Prepack is recalling 12 bottles of Spironolactone 50 mg tablets because they may contain 25 mg tablets due to a labeling error.

    Product
    Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0300-2021·2021-03-24

    Direct Rx Recalls Nortriptyline HCL Capsules Due to cGMP Deviation

    Direct Rx is recalling 17 bottles of Nortriptyline HCL 10 mg capsules because the active ingredient was taken from an unqualified supplier lot.

    Product
    Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0308-2021·2021-03-24

    Breckenridge Recalls Omeprazole Capsules Due to Unknown Impurities

    Breckenridge Pharmaceutical is recalling 3,146 bottles of Omeprazole Delayed-Release Capsules, 20 mg, due to out-of-specification results for unknown impurities.

    Product
    Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1249-2021·2021-03-24

    Medline Recalls RNA Medical Hemoglobin Control Product Due to Shipment Compromise

    Medline Industries is recalling 4 units of RNA Medical Hemoglobin Control product because the product was compromised during shipment. The recall affects distribution in Kentucky, Pennsylvania, and Ohio.

    Product
    RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0363-2021·2021-03-24

    Electrolit Fruit Punch Recalled for Undeclared Red Dye

    Laboratorios Pisa is recalling Electrolit Fruit Punch bottles and 6-packs because they contain undeclared FD&C Red No. 40.

    Product
    Electrolit Ponche/Fruit Punch; in 625 mL/21 oz and 300ML/10oz bottles; and Electrolit Fruit Punch 6 Pack, 625mL/21 oz; Packaged in a polypropylene bottle with volume capacity 625 mL and a polypropylene lid and liner with a high-density polyethylene safety ring.
    Category
    Food
    Distribution
    22 states
  • ModerateFDA (Drugs)·D-0301-2021·2021-03-24

    Akorn Recalls Gabapentin Oral Solution Due to Impurity Specifications

    Akorn, Inc. is recalling Gabapentin Oral Solution because it failed impurity specifications during stability testing. The product was distributed nationwide.

    Product
    Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0309-2021·2021-03-24

    Teva Recalls Romidepsin Injection Vials Due to Impurity Failures

    Teva Pharmaceuticals is recalling 1,416 vials of Romidepsin Injection because stability testing revealed out-of-specification impurities.

    Product
    Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0364-2021·2021-03-24

    Electrolit Fruit Punch Zero Recalled for Undeclared Red Dye

    Laboratorios Pisa Sa De Cv is recalling 571,590 bottles of Electrolit Fruit Punch Zero because the product contains undeclared FD&C Red No. 40.

    Product
    Electrolit Fruit Punch Zero, 625ML/21OZ packaged in a polypropylene bottle with volume capacity of 625mL and with a polypropylene lid and liner with a high-density polyethylene safety ring.
    Category
    Food
    Distribution
    22 states
  • LowFDA (Drugs)·D-0306-2021·2021-03-24

    Edge Pharma Recalls Methacholine Challenge Test Kits Due to Storage Labeling Error

    Edge Pharma is recalling Methacholine Challenge 5-Syringe Test Kits because they were labeled with incorrect room temperature storage conditions instead of the required refrigerated conditions.

    Product
    Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0307-2021·2021-03-24

    Edge Pharma Recalls Epinephrine/Lidocaine Ophthalmic Solution Due to Labeling Errors

    Edge Pharma, LLC is recalling 60 syringes of Epinephrine/Lidocaine HCl sterile ophthalmic solution for injection due to incorrect or missing lot and expiration dates.

    Product
    Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·21V198000·2021-03-22

    Audi Recalls A3 and S3 Models Due to Passenger Air Bag Defect

    Volkswagen Group of America is recalling specific Audi A3 and S3 models because the passenger air bag may deactivate while the seat is occupied.

    Product
    AUDI — AUDI RS 3, S3, A3, A3 SPORTBACK E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·009-2021·2021-03-20

    Avanza Pasta Recalls Beef and Poultry Products Lacking Federal Inspection

    Avanza Pasta, LLC is recalling approximately 9,847 pounds of beef and poultry ravioli and tortellini produced without federal inspection. No adverse reactions have been reported.

    Product
    Avanza Pasta, LLC Recalls Beef and Poultry Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V194000·2021-03-19

    Isuzu and Chevrolet Trucks Recalled for Rear Axle U-Bolt Nut Defect

    Isuzu is recalling 2015-2021 Isuzu, Chevrolet, and International trucks because rear axle U-bolt nuts may loosen, causing axle misalignment and potential loss of power.

    Product
    ISUZU — ISUZU, CHEVROLET, INTERNATIONAL MOTORS NPR XD, NRR, NPR HD, NQR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V197000·2021-03-19

    Mercedes-Benz Recalls Vehicles with Potential Front Roof Panel Bonding Defect

    Mercedes-Benz is recalling specific 2014-2020 models equipped with panoramic sunroofs because the front roof panel may not have been bonded correctly during a prior repair.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 300, S 450, C 350 E, CLA 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V196000·2021-03-19

    Mercedes-Benz Recalls 2006-2007 Models for Sunroof Glass Detachment Risk

    Mercedes-Benz is recalling 11,356 vehicles because the sunroof glass may detach, creating a road hazard and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ E350, AMG E55, AMG E63, AMG CLS63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-03192021-01·2021-03-19

    USDA Issues Public Health Alert for Uninspected Beef and Lamb Products

    USDA FSIS issued a public health alert for specific beef and lamb products from One Meat Corp. that were produced without federal inspection.

    Product
    FSIS Issues Public Health Alert for Beef and Lamb Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V190000·2021-03-18

    Damaged Third-Row Seat Belts in 2021 GM Full-Size SUVs

    General Motors is recalling 2021 full-size SUVs because third-row seat belts may be entrapped or misrouted behind the seat-folding mechanism, potentially becoming damaged. A damaged seat belt could break during a crash, increasing the risk of occupant injury.

    Product
    GMC — GMC, CADILLAC, CHEVROLET YUKON, ESCALADE, SUBURBAN, ESCALADE ESV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21098·2021-03-18

    HD Hudson Recalls illu-Mist Battery-Powered Garden Sprayers Due to Fire Hazard

    HD Hudson is recalling illu-Mist battery-powered garden sprayers because the lithium-ion battery can overheat and catch fire. Consumers should stop using the sprayers and contact the company for a replacement.

    Product
    illu-Mist Battery-Powered Garden Sprayers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V191000·2021-03-18

    Arcimoto Recalls FUV and Deliverator Vehicles Due to Battery Shutdown Risk

    Arcimoto is recalling 2019-2020 FUV and 2020 Deliverator vehicles because high-voltage contactors may overheat, causing unexpected battery shutdowns and loss of motive power.

    Product
    ARCIMOTO — ARCIMOTO FUV, DELIVERATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V189000·2021-03-18

    GM Recalls 2021 Chevrolet Express and GMC Savana for Fire Risk

    General Motors is recalling 2021 Chevrolet Express and GMC Savana vans with 6.6L engines because a battery cable defect may cause a short circuit and fire.

    Product
    CHEVROLET — CHEVROLET, GMC EXPRESS, SAVANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V193000·2021-03-18

    2021 Tiffin Phaeton recreational vehicles recalled for loose valve stem

    Tiffin is recalling certain 2021 Phaeton recreational vehicles because the valve stem stabilizer can become loose, allowing the valve stem extender to contact the wheel, which can cause tire pressure loss and increase crash risk.

    Product
    TIFFIN — TIFFIN PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21730·2021-03-18

    Briggs & Stratton Recalls YTL Log Splitters Due to Engine Kickback Injury Hazard

    Briggs & Stratton is recalling YTL log splitters with 250cc engines due to a risk of engine kickback causing injury. Two incidents involving broken wrists have been reported.

    Product
    YTL Log Splitters with Briggs & Stratton 250cc engines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V188000·2021-03-18

    Chevrolet 2021 Camaro Axle Shaft Separation Defect Recall

    General Motors is recalling certain 2021 Chevrolet Camaro vehicles because the left or right axle shaft may be missing a retaining ring, which could separate during driving and cause loss of power, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET CAMARO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1236-2021·2021-03-17

    Pioneer Surgical Technology Recalls CervAlign Anterior Cervical Plate System

    RTI Surgical, Inc. is recalling the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1229-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1213-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1233-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1235-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1248-2021·2021-03-17

    Medtronic Guide Catheter Recalled Due to Potential Sterility Compromise

    Medtronic Vascular is recalling 137 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.

    Product
    Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1227-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1223-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1210-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1206-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1214-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1218-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1185-2021·2021-03-17

    Brainlab ExacTrac Dynamic Radiation Therapy System Software Recall

    Brainlab AG is recalling ExacTrac Dynamic radiation therapy systems due to a software error that may allow treatment despite exceeding position tolerances.

    Product
    ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1237-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring surgical revision.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1242-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1225-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1240-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V182000·2021-03-17

    2021 Newmar Motorhomes Recalled for Missing Brake Pedal Return Spring

    Newmar is recalling 2021 New Aire, Dutch Star, and Ventana motorhomes because the brake pedal assembly may be missing a return spring. This can cause brake lights to stay on and brakes to remain engaged, increasing crash risk.

    Product
    NEWMAR — NEWMAR NEW AIRE, DUTCH STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1234-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate during or after surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V183000·2021-03-17

    Braun Recalls Demers Ambulances Due to Sliding Seat Locking Pin Defect

    Braun Ambulances is recalling certain 2019-2021 Demers ambulances because the sliding attendant seat locking pin may fail, increasing injury risk in a crash.

    Product
    DEMERS AMBULANCES — DEMERS AMBULANCES MX170E FORD E-SERIES, TYPE I (MXP170E)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1241-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1231-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recall for Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1216-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1232-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate during or after surgery, requiring revision.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1224-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1238-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1211-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1247-2021·2021-03-17

    Medtronic Guide Catheter Recalled for Potential Sterility Compromise

    Medtronic Vascular is recalling 10 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.

    Product
    Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1226-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1209-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1239-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1208-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1228-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recall for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1177-2021·2021-03-17

    Draeger VentStar Anesthesia Breathing Circuits Recalled for Detachment Risk

    Draeger Medical is recalling VentStar Anesthesia breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.

    Product
    VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1201-2021·2021-03-17

    Medtronic Recalls Valiant Navion Thoracic Stent Grafts Due to Structural Defects

    Medtronic is recalling 33,430 Valiant Navion Thoracic Stent Graft Systems worldwide due to endoleaks, stent fractures, and ring enlargement.

    Product
    Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1219-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1204-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling 65 units of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1215-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0335-2021·2021-03-17

    Green City Distribution Recalls Al-Riyan Tuna Meat Due to High Histamine Levels

    Green City Distribution is recalling Al-Riyan Tuna Meat in Vegetable Oil because of high levels of histamines. The product was distributed in California, Michigan, Tennessee, and New York.

    Product
    Al-Riyan Tuna Meat in Vegetable oil 7 oz. can 48 cans per case
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1222-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1217-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1221-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Defect

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1243-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1230-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1246-2021·2021-03-17

    Medtronic Guide Catheter Recalled Due to Potential Sterility Compromise

    Medtronic Vascular is recalling 9 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.

    Product
    Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1244-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1220-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1205-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide

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