The Recall Desk

Archive

February 2021 recalls

492 recalls were announced in February 2021.

What the numbers show

Critical
13
Severe
91
High
325
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·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·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 ESSEX, KING AIRE, DUTCH STAR, LONDON AIRE
    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·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·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
  • 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
  • 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
  • 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…
    Category
    Drug
    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 (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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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
  • 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 (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-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
  • 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
  • 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-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-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-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-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-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-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
  • 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 (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-1026-2021·2021-02-17

    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.

    Product
    INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-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-1029-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recall Due to 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 25G 6MM, model no. NM-401L-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-1023-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, which could allow non-sterile equipment to be used and cause infection.

    Product
    INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-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-1014-2021·2021-02-17

    Aomori Olympus Endoscopic Injector Recall Due to Package Seal Defects

    Aomori Olympus is recalling specific endoscopic 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 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
  • HighFDA (Devices)·Z-0977-2021·2021-02-17

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

    Aomori Olympus Co., Ltd. is recalling KD-620LR Electrosurgical Snare units because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - 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-1013-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, creating a risk of infection 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 (Devices)·Z-1008-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Injectors Due to Package Seal Defects

    Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and cause infection.

    Product
    INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-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-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-0996-2021·2021-02-17

    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 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-1068-2021·2021-02-17

    Aomori Olympus Recalls MAJ-247 Replacement Baskets Due to Seal Defects

    Aomori Olympus is recalling MAJ-247 replacement baskets for the BML-3Q Mechanical Lithotripter because some sterile packages have inadequate seals, posing an infection risk.

    Product
    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2021·2021-02-17

    Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling SD-240U-10 electrosurgical snares because inspection found inadequate package seals. Non-sterile equipment use may lead to patient infection.

    Product
    SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2021·2021-02-17

    Aomori Olympus Biliary Stent Recalled for Inadequate Package Seals

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

    Product
    PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2021·2021-02-17

    Aomori Olympus Endoscopic Injector Recall Due to Package Seal Defects

    Aomori Olympus is recalling specific endoscopic injectors because inspection found some sterile packages had inadequate seals, posing a risk of infection if used.

    Product
    INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-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-1064-2021·2021-02-17

    Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals

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

    Product
    PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2021·2021-02-17

    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.

    Product
    INJECTOR FORCEMAX LOWER 23G 6MM, 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
  • 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-1101-2021·2021-02-17

    GE Healthcare Precision 600FP Monitor Suspension Recall

    GE Healthcare is recalling 113 Precision 600FP systems due to a potential monitor suspension defect that could cause injury.

    Product
    GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body…
    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-1012-2021·2021-02-17

    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 if used.

    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-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 (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-1105-2021·2021-02-17

    BEMER Therapy Systems Recalled for Potential Interference with Pacemakers and Insulin Pumps

    BEMER International AG is recalling Bemer-Set and Pro-Set therapy systems because electromagnetic fields may cause technical defects in insulin pumps or pacemaker malfunctions.

    Product
    Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • HighFDA (Devices)·Z-1067-2021·2021-02-17

    Aomori Olympus Recalls MAJ-244 Replacement Baskets Due to Seal Defects

    Aomori Olympus is recalling MAJ-244 replacement baskets for the BML-3Q Mechanical Lithotripter because some sterile packages have inadequate seals, posing an infection risk.

    Product
    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2021·2021-02-17

    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 5MMx 25G UPPER, model no. NM-610L-0525 - 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-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-0981-2021·2021-02-17

    Aomori Olympus Recalls KD-650U Electrosurgical Snare Due to Seal Defects

    Aomori Olympus Co., Ltd. is recalling KD-650U Electrosurgical Snare units because inspection found some sterile packages have inadequate seals, posing an infection risk.

    Product
    KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - 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-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…
    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-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-1035-2021·2021-02-17

    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 used.

    Product
    NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-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-1085-2021·2021-02-17

    Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes

    Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.

    Product
    Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG 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…
    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-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 (Devices)·Z-1100-2021·2021-02-17

    Arjo Flat Dynamic Positioning System Recalled for Sling Clip Breakage Risk

    Arjohuntleigh Magog is recalling 3,390 Arjo Flat Dynamic Positioning Systems due to a risk of sling clip breakage during use.

    Product
    Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2021·2021-02-17

    Draegar Infinity Acute Care System Recall for Random Reboot Defect

    Draegar Medical Systems is recalling Infinity Acute Care System monitors that may randomly reboot due to a memory error, potentially interrupting patient monitoring.

    Product
    Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster 3mm x 26G Lower needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - 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-0992-2021·2021-02-17

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

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

    Product
    SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - 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-1052-2021·2021-02-17

    Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2021·2021-02-17

    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 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    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-0965-2021·2021-02-17

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

    Aomori Olympus is recalling B7-2Q Balloon Catheters because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -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-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
  • 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-1031-2021·2021-02-17

    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 an infection risk.

    Product
    NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-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-1070-2021·2021-02-17

    Aomori Olympus Recalls Crescent Snare Due to Inadequate Package Seals

    Aomori Olympus Co., Ltd. is recalling Crescent Snare models due to inadequate package seals that may compromise sterility and increase infection risk.

    Product
    CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    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-1032-2021·2021-02-17

    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 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI 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-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
  • 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-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 (Food)·F-0289-2021·2021-02-17

    Publix Parmesan-Crusted Wild Alaskan Salmon Recalled for Undeclared Soy

    Ocean Beauty Seafoods LLC is recalling 845 cases of Publix Parmesan-Crusted Wild Alaskan Salmon Fillets due to undeclared soy. The product was distributed in Florida and Georgia.

    Product
    The RETAIL package is black cardboard box and product is described as: Publix Parmesan-Crusted Wild Alaskan Salmon Fillets, Frozen, net wt. 12 oz. Each retail box has 2 individually vacuum-packaged portions of 5oz salmon with 1oz of glaze of soy sauce for each portion. The…
    Category
    Food
    Distribution
    2 states
  • 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-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-0972-2021·2021-02-17

    Aomori Olympus Recalls K-203 Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.

    Product
    K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2021·2021-02-17

    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 6MMx 23G LOWER, model no. NM-610U-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-1048-2021·2021-02-17

    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 6MMx 25G LOWER, model no. NM-610U-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-0970-2021·2021-02-17

    Aomori Olympus Recalls K-201 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
  • HighFDA (Devices)·Z-1055-2021·2021-02-17

    Aomori Olympus Recalls Aspiration Needles Due to Seal Defects

    Aomori Olympus is recalling NA-401D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - 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-1001-2021·2021-02-17

    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 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-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 (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-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

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