The Recall Desk

Archive

February 2021 recalls

492 recalls were announced in February 2021.

What the numbers show

Critical
13
Severe
87
High
329
Moderate
56
Low
7

Of the 492 recalls this month scored against our rubric, 3% are Critical, 18% are Severe.

101–200 of 492

  • HighNHTSA·21V086000·2021-02-18

    2020-2021 Mazda CX-30 Power Liftgate May Lower Unexpectedly on Slopes

    Mazda is recalling certain 2020-2021 CX-30 vehicles because the power liftgate may partially lower unexpectedly when parked on uphill slopes, risking injury to those accessing the rear storage area.

    Product
    MAZDA — MAZDA CX-30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V089000·2021-02-18

    2021 BMW X5 Models Recalled for Potentially Loose Brake Disc Fasteners

    BMW is recalling certain 2021 X5 sDrive40i and X5 xDrive40i vehicles because the right front brake disc may have incorrect fasteners that could loosen over time, affecting vehicle control and increasing crash risk.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V088000·2021-02-18

    Newmar motorhomes recalled for steering gear bolts backing out

    Newmar is recalling 2020-2022 motorhomes due to steering gear mounting bolts that may back out, potentially causing loss of steering control. Owners should contact Newmar for a free replacement of affected bolts.

    Product
    NEWMAR — NEWMAR LONDON AIRE, DUTCH STAR, ESSEX, MOUNTAIN AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V093000·2021-02-18

    Autocar Xpeditor and Legend Vehicles Instrument Display May Hide Warning Lights

    Certain 2019-2021 Autocar Xpeditor and 2021-2022 Legend vehicles with a 7-inch display may experience restarts that hide critical warning lights. Dealers will replace the display free of charge.

    Product
    AUTOCAR — AUTOCAR XPEDITOR, LEGEND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V095000·2021-02-18

    Autocar Xpeditor turbocharger heat shield may detach from vehicle

    Autocar is recalling certain 2018-2021 Xpeditor vehicles because the turbocharger heat shield may fail and detach, creating a road hazard. Dealers will replace the component free of charge.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V094000·2021-02-18

    Great Dane Recalls 2021-2022 Trailers Due to Brake Sensor Wiring Error

    Great Dane is recalling 2021-2022 Champion and 2022 Everest trailers because anti-lock brake sensor cables may be plugged into the wrong ports, increasing crash risk.

    Product
    GREAT DANE — GREAT DANE CHAMPION, EVEREST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0262-2021·2021-02-17

    Apotex Recalls Enoxaparin Syringes Due to Labeling Mixup

    Apotex Corp. is recalling Enoxaparin Sodium Injection syringes because some barrels may display incorrect concentration markings, posing a risk of dosing errors.

    Product
    Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-079
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0275-2021·2021-02-17

    Maine Grains Organic Yellow Peas Recalled for Undeclared Soy

    Maine Grains Inc. is recalling Organic Yellow Peas due to undeclared soy. The product was sold in various packaging formats across multiple states.

    Product
    Maine Grains Inc. brand Organic Yellow Peas sold between 10/17/2019 and 11/1/2020; product was packaged in 25lb bulk bags, 12 x 1lb cases; and clear cellophane 1lb bags sold online and labelled as "Crop Rotation Organic Yellow Peas"
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-0279-2021·2021-02-17

    Sprout's Yogurt Covered Cranberries Recalled for Undeclared Almonds

    Ohio Hickory Harvest is recalling Sprout's Vanilla Flavored Yogurt Covered Cranberries due to undeclared almonds, a tree nut allergen.

    Product
    Sprout's Vanilla Flavored Yogurt Covered Cranberries UPC 646670463778 12 Ounce Stand-Up Pouch Bag Ambient Storage
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·21V082000·2021-02-17

    Newmar motorhome brake light switches may fail to illuminate

    Newmar is recalling 2017–2021 Dutch Star and 2021 Kountry Star motorhomes because the brake light switch may chafe against the windshield wiper mechanism, preventing brake lights from illuminating. This increases crash risk.

    Product
    NEWMAR — NEWMAR DUTCH STAR, KOUNTRY STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0287-2021·2021-02-17

    EVR Foods Recalls LAVVA Blueberry Pili Nut Yogurt for Potential Mold

    EVR Foods Inc. is recalling LAVVA Blueberry Dairy Free Pili Nut Yogurt because the product may contain mold. The recall covers 806 cases distributed across 14 states.

    Product
    "LAVVA Blueberry Dairy Free Pili Nut Yogurt. NO SUGAR ADDED. NET WT 5.3OZ (150g) ***KEEP REFRIGERATED***DISTRIBUTED BY EVR FOODS INC. NEW YORK, NY 10010"
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Devices)·Z-1074-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy System Due to Sheath Separation

    Argon Medical Devices is recalling the TLAB Transjugular Liver Biopsy System because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Drugs)·D-0261-2021·2021-02-17

    Apotex Recalls Enoxaparin Syringes Due to Labeling Mixup

    Apotex Corp. is recalling Enoxaparin Sodium Injection syringes because some barrels may display incorrect strength markings.

    Product
    Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 U
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E014000·2021-02-17

    Cummins Recalls B6.7N Natural Gas Engines Due to Software Calibration Error

    Cummins is recalling certain Westport B6.7N natural gas engines because incorrect software calibration may prevent the engine from limiting speed or torque, potentially compromising safety functions like braking and stability control.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:ENGINE CONTROL MODULE (ECU/ECM):SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V076000·2021-02-17

    Ford Recalls 2004-2006 Rangers for Air Bag Inflator Defect

    Ford is recalling 2004-2006 Ranger vehicles because certain replacement air bag inflators may explode during deployment, potentially causing serious injury or death.

    Product
    FORD — FORD RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0252-2021·2021-02-17

    Lidocaine/Tetracaine Ointment Recalled for Higher Concentration Than Listed

    Stanley Specialty Pharmacy is recalling Lidocaine/Tetracaine ointment because the lidocaine concentration is higher than listed on the label.

    Product
    Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1084-2021·2021-02-17

    Wahl Heated Massager Recalled Due to Fire Hazard

    Wahl Clipper Corp is recalling 161 units of the WAHL 4212 Heated Massager because the connection between the massager and heat element can overheat, posing a fire hazard.

    Product
    WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1072-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy Systems

    Argon Medical Devices is recalling 483 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Food)·F-0278-2021·2021-02-17

    Reese Hollandaise Sauce Recalled Due to Compromised Vacuum Seals

    World Finer Foods is recalling Reese Hollandaise Sauce in 7.5 oz glass jars due to compromised vacuum seals and product expansion that may allow microorganism growth.

    Product
    Reese Hollandaise Sauce packaged in glass jars 7.5 oz UPC: 7067060108
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Devices)·Z-0990-2021·2021-02-17

    Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling SD-240U-25 electrosurgical snares because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0960-2021·2021-02-17

    Cook Medical Kwart Retro-Inject Ureteral Stent Set Recalled for Material Defect

    Cook Inc. is recalling 42 units of Kwart Retro-Inject Ureteral Stent Sets because they were manufactured with incorrect material, which may cause the stent to be stiffer and susceptible to degradation, breakage, or fragmentation.

    Product
    Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1075-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy Systems

    Argon Medical Devices is recalling 247 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-1076-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy Systems Due to Sheath Separation

    Argon Medical Devices is recalling 1,759 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-1073-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy Systems

    Argon Medical Devices is recalling 863 TLAB Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-1077-2021·2021-02-17

    Argon Medical Devices Recalls Transjugular Liver Biopsy Systems

    Argon Medical Devices is recalling 583 Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.

    Product
    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-1010-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seal

    Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2021·2021-02-17

    Aomori Olympus Recalls Endoscopic Injectors Due to Package Seal Defects

    Aomori Olympus is recalling endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V078000·2021-02-17

    2020-2021 Audi Q7 recalled for premature air bag deployment hazard

    The air bag control module in certain 2020-2021 Audi Q7 vehicles may deploy the second stage of the front passenger air bag too quickly when an unbelted child is in the seat, increasing injury risk. Audi will update the module at no cost.

    Product
    AUDI — AUDI Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2021·2021-02-17

    Baxter IV Catheter Extension Set Recalled for Tubing Separation

    Baxter Healthcare is recalling 66,800 units of ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Sets due to reports of tubing separation from the Male Luer Lock Adaptor.

    Product
    Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2021·2021-02-17

    Aomori Olympus Endoscopic Injector Recall Due to Inadequate Package Seals

    Aomori Olympus is recalling INJECTOR FORCEMAX LOWER 23G 4MM devices because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2021·2021-02-17

    Aomori Olympus Recalls Electrosurgical Snare Due to Seal Defects

    Aomori Olympus is recalling KD-655L electrosurgical snares because some sterile packages have inadequate seals, posing an infection risk.

    Product
    KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2021·2021-02-17

    Aomori Olympus Recalls 22G EZSHOT Aspiration Needles Due to Seal Defects

    Aomori Olympus is recalling 22G EZSHOT aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0328-2021·2021-02-17

    Kowalski's Buffalo Cauliflower Bites Recalled for Undeclared Fish

    Russ Davis Wholesale Inc is recalling Kowalski's Buffalo Cauliflower Bites because the included blue cheese dressing may contain undeclared fish (anchovies).

    Product
    Kowalski's Buffalo Cauliflower Bites with Kowalski's Steakhouse Blue Dressing. Net Wt. 22 oz (1 lb. 6 oz) 624 g. UPC 95631-89341. Keep Refrigerated. MFG BY: RDW Eagan, MN 55121
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0976-2021·2021-02-17

    Aomori Olympus Recalls KD-612U Electrosurgical Snare Due to Seal Defects

    Aomori Olympus is recalling KD-612U electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2021·2021-02-17

    Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals

    Aomori Olympus is recalling NA-411D-1321 aspiration needles because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax injectors because inspection found some sterile packages had inadequate seals, posing an infection risk if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2021·2021-02-17

    Aomori Olympus Recalls 3-Lumen Extraction Balloon V Due to Seal Defects

    Aomori Olympus is recalling 3-Lumen Extraction Balloon V devices because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2021·2021-02-17

    Aomori Olympus Recalls ForceMax UP Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax UP injectors because some sterile packages have inadequate seals, posing an infection risk.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V077000·2021-02-17

    Mercedes-Benz Sprinter Recall for Rearview Camera Display Delay

    Daimler Vans USA is recalling 2019-2020 Mercedes-Benz and Freightliner Sprinter vans because the rearview camera image may be delayed or obscured, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 4500, SPRINTER 2500, SPRINTER 3500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V083000·2021-02-17

    Blue Bird Recalls 2021-2022 School Buses Due to Electronic Stability Control Defect

    Blue Bird is recalling 2021-2022 Vision and 2022 All American school buses because the hydraulic brake control unit may be programmed incorrectly, causing electronic stability control to malfunction.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1051-2021·2021-02-17

    Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-202 Guide Sheath Kits because some sterile packages have inadequate seals, posing an infection risk.

    Product
    K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21081·2021-02-17

    Jimco Recalls J Hunt Home Accent Tables Due to Shock Hazard

    Jimco Lamp is recalling J Hunt Home accent tables with charging receptacles due to a shock hazard caused by reverse polarity. No injuries have been reported.

    Product
    J Hunt Home and J Hunt and Co. Accent Tables with Charging Receptacles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21080·2021-02-17

    Toro Recalls Power Max Snowthrowers Due to Amputation Hazard

    Toro is recalling about 6,700 Power Max 826 OHAE snowthrowers because the auger may fail to disengage, posing an amputation hazard.

    Product
    Toro Power Max Snowthrowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recall Due to Package Seal Defects

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2021·2021-02-17

    Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects

    Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, and foreign material that may compromise barrier protection.

    Product
    Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing an infection risk if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0286-2021·2021-02-17

    Glanbia Recalls think! Oatmeal Bowls Due to Undeclared Nuts

    Glanbia Performance Nutrition is recalling think! Protein + Fiber Oatmeal bowls because they contain undeclared pecans and almonds.

    Product
    think! Protein + Fiber Oatmeal, Farmer's Market Berry Crumble bowl 1.76 oz. individual unit UPC 753656711836 also sold in retail 6 pack with UPC 753656712338
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2021·2021-02-17

    Becton Dickinson Recalls BioGX SARS-CoV-2 Reagents Due to Mislabeled Pouches

    Becton Dickinson is recalling 938 kits of BioGX SARS-CoV-2 Reagents because some master mix pouches may be mislabeled, potentially leading to false negative test results.

    Product
    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2021·2021-02-17

    Aomori Olympus Recalls Electrosurgical Snare Due to Inadequate Package Seals

    Aomori Olympus is recalling KD-655U electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2021·2021-02-17

    Aomori Olympus Recalls KD-640L Electrosurgical Snare Due to Seal Defects

    Aomori Olympus is recalling KD-640L electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2021·2021-02-17

    Aomori Olympus Recalls B7-2LA Balloon Catheters Due to Seal Defects

    Aomori Olympus is recalling B7-2LA Balloon Catheters because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.

    Product
    B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2021·2021-02-17

    Aomori Olympus Recalls K-204 Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-204 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0282-2021·2021-02-17

    Pero Family Farms Recalls Butternut Squash Due to Listeria Risk

    Pero Family Farms is recalling 7,111 cases of cubed butternut squash due to potential Listeria monocytogenes contamination.

    Product
    Butternut Cubed Butternut Tray, Keep Refrigerated, NET WT 13oz (368g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1007-2021·2021-02-17

    Aomori Olympus ForceMax Endoscopic Injectors Recalled for Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing an infection risk if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2021·2021-02-17

    Aomori Olympus Recalls KD-611L Electrosurgical Knives Due to Seal Defects

    Aomori Olympus is recalling KD-611L electrosurgical knives because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1044-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles for Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing an infection risk.

    Product
    NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2021·2021-02-17

    Aomori Olympus Crescent Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling Crescent Snare devices due to inadequate package seals that may compromise sterility, posing an infection risk.

    Product
    CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2021·2021-02-17

    Aomori Olympus Recalls KD-612L Electrosurgical Knives Due to Seal Defects

    Aomori Olympus is recalling KD-612L electrosurgical knives because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and cause infection.

    Product
    KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2021·2021-02-17

    Aomori Olympus Recalls SNAREMASTER PLUS Hot/Cold Snare Due to Seal Defects

    Aomori Olympus is recalling SNAREMASTER PLUS Hot/Cold snares because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0281-2021·2021-02-17

    Pero Family Farms Recalls Butternut Squash Spirals Due to Listeria Risk

    Pero Family Farms is recalling Butternut Veggie Spirals trays due to potential Listeria monocytogenes contamination. Consumers should check their refrigerators for affected products.

    Product
    Butternut Veggie Spirals Tray, Keep Refrigerated, NET WT 9.5oz (269g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1028-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing an infection risk.

    Product
    NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2021·2021-02-17

    Aomori Olympus Recalls 3-Lumen Extraction Balloon V Due to Seal Defects

    Aomori Olympus is recalling 3-Lumen Extraction Balloon V devices because some sterile packages have inadequate seals, posing an infection risk.

    Product
    B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2021·2021-02-17

    Aomori Olympus Recalls B7-2C Balloon Catheters Due to Seal Defects

    Aomori Olympus is recalling B7-2C Balloon Catheters because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.

    Product
    B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1000-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax UP injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2021·2021-02-17

    Aomori Olympus Recalls PR-V614M 2-Lumen Cannulas Due to Seal Defects

    Aomori Olympus is recalling PR-V614M 2-Lumen Cannulas because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2021·2021-02-17

    Aomori Olympus Recalls KD-620UR Electrosurgical Snare Due to Seal Defects

    Aomori Olympus Co., Ltd. is recalling KD-620UR Electrosurgical Snare units because inspection found inadequate package seals, which could compromise sterility and lead to patient infection.

    Product
    KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0285-2021·2021-02-17

    Pero Family Farms Recalls Butternut Squash Bags Due to Listeria Risk

    Pero Family Farms is recalling 5 lb bags of butternut squash potentially contaminated with Listeria monocytogenes. The recall covers 155 cases distributed domestically.

    Product
    Butternut Squash Bag, 5 lbs
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1016-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, which could lead to patient infection.

    Product
    INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing an infection risk if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects

    Aomori Olympus is recalling 260,395 NeedleMaster needles in the US because some sterile packages have inadequate seals, posing an infection risk.

    Product
    NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing an infection risk.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster 6mm x 23G Upper needles because some sterile packages have inadequate seals, posing an infection risk.

    Product
    NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2021·2021-02-17

    Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling SD-210U-10 electrosurgical snares because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2021·2021-02-17

    Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling SD-230U-20 electrosurgical snares because some sterile packages have inadequate seals, posing an infection risk.

    Product
    SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2021·2021-02-17

    Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-201 Guide Sheath Kits because some sterile packages have inadequate seals, posing an infection risk if used.

    Product
    K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V080000·2021-02-17

    2021-2022 Kenworth and Peterbilt trucks recalled for improperly torqued flywheel attachment

    PACCAR is recalling certain 2021-2022 Kenworth and Peterbilt heavy trucks equipped with Cummins X15 engines. The flywheel attachment capscrews may be improperly torqued, risking flywheel detachment and loss of drive power.

    Product
    PETERBILT — PETERBILT, KENWORTH 389, 567, T800B, W900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1004-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection.

    Product
    INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax injectors because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2021·2021-02-17

    Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-202 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2021·2021-02-17

    Aomori Olympus Recalls ViziShot Aspiration Needles Due to Seal Defects

    Aomori Olympus is recalling ViziShot aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2021·2021-02-17

    Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals

    Aomori Olympus is recalling biliary stents because inspection found some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2021·2021-02-17

    Roche 9180 Electrolyte Analyzer Recalled for Incorrect Calcium Display Arrows

    Roche Diagnostics is recalling 1,214 units of the 9180 Electrolyte Analyzer because the device may display incorrect arrow directions for ionized calcium results when configured in mg/dL, potentially leading to misinterpretation.

    Product
    9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials. catalog number 03157334001 . in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Lower Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax Lower injectors because some sterile packages have inadequate seals, posing an infection risk if used.

    Product
    INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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