The Recall Desk

Archive

September 2020 recalls

631 recalls were announced in September 2020.

What the numbers show

Critical
56
Severe
123
High
285
Moderate
154
Low
13

Of the 631 recalls this month scored against our rubric, 9% are Critical, 19% are Severe.

501–600 of 631

  • SevereFDA (Devices)·Z-2856-2020·2020-09-02

    Globus Medical Recalls ALTERA Spacers Due to Incorrect Material Composition

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may be made of stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1268-2020·2020-09-02

    Emerald Fruit & Produce Recalls Diced Onions for Salmonella Risk

    Emerald Fruit & Produce Inc is recalling diced onions sold for foodservice use due to potential Salmonella Newport contamination.

    Product
    M60058CS Onions White Diced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1261-2020·2020-09-02

    Emerald Fruit & Produce Recalls Diced Onions for Salmonella Risk

    Emerald Fruit & Produce Inc. is recalling diced yellow onions for foodservice use due to potential Salmonella Newport contamination.

    Product
    M60025CS Onions Yellow Diced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2831-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,275 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1256-2020·2020-09-02

    Progressive Produce Recalls Yellow Onions Supplied by Thomson Onions

    Progressive Produce LLC is recalling yellow onions supplied by Thomson Onions. The onions were distributed for retail sale in bulk bins.

    Product
    Yellow Onions; Pacific Gold 50 Lb. SX Yellow onion w/PLU sticker Sold to consumers in bulk bins
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1262-2020·2020-09-02

    Emerald Fruit & Produce Recalls Peeled Onions for Salmonella Newport Risk

    Emerald Fruit & Produce Inc is recalling 160 lbs of peeled yellow onions for foodservice use in Oregon due to potential Salmonella Newport contamination.

    Product
    M60027CS Onions Yellow Whole Peeled sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1265-2020·2020-09-02

    Emerald Fruit & Produce Recalls Unlabeled Red Onions for Salmonella Risk

    Emerald Fruit & Produce Inc is recalling 80 lbs of unlabeled red onions in Oregon due to potential Salmonella Newport contamination.

    Product
    Onions Red Whole Dry 5 lb. bag (item 78156) for food service use, shelf life 14 days, packed in 5 lbs. cello bag and stored in box - No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1264-2020·2020-09-02

    Emerald Fruit & Produce Recalls Red Diced Onions for Salmonella Risk

    Emerald Fruit & Produce Inc is recalling 45 lbs of red diced onions sold in Oregon due to potential Salmonella Newport contamination.

    Product
    M60022CS Onions Red Diced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1266-2020·2020-09-02

    Emerald Fruit & Produce Recalls Red Onions for Salmonella Newport Risk

    Emerald Fruit & Produce Inc is recalling M60024CS Red Whole Peeled Onions due to potential Salmonella Newport contamination. The product was distributed in Oregon for foodservice use.

    Product
    M60024CS Onions Red Whole Peeled sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2850-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacer Implants Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacer implants because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·20V534000·2020-09-02

    Tiffin Recalls 2020 Bus and Phaeton Motorhomes for Steering Bolt Issue

    Tiffin Motorhomes is recalling 2020 Bus and Phaeton models because steering pinch bolts may not be properly tightened, which could lead to a loss of steering control.

    Product
    TIFFIN — TIFFIN BUS, PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1363-2020·2020-09-02

    Organic Valley Egg Bites Recalled for Missing Allergen Labeling

    Almark Foods is recalling Organic Valley Egg Bites because the packaging is missing the back panel with ingredient and allergen information.

    Product
    ORGANIC VALLEY EGG BITES feta & chives NET WT 4 OZ (114g) UPC# 0 93966 81195 7 Distributed by Organic Valley, La Farge, WI 54639
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1312-2020·2020-09-02

    Wegmans Recalls Whole Seasoned Snapper Due to Listeria Contamination Risk

    Wegmans is recalling Whole Seasoned Snapper sold in several states because it may be contaminated with Listeria monocytogenes.

    Product
    Whole Seasoned Snapper; by the lb.; whole seasoned snapper with lemon and oil; packaged in an oven ready tray; total package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1310-2020·2020-09-02

    Wegmans Recalls Seasoned Whole Bronzini Due to Listeria Risk

    Wegmans Food Markets is recalling seasoned whole bronzini potentially contaminated with Listeria monocytogenes. Consumers should not eat the product and should return it to the store.

    Product
    Seasoned Whole Bronzini; by the lb.; whole bronzini with lemon, parsley, and thyme; packaged in an oven ready tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1311-2020·2020-09-02

    Wegmans Recalls Seasoned Whole Rainbow Trout Due to Listeria Risk

    Wegmans Food Markets is recalling seasoned whole rainbow trout potentially contaminated with Listeria monocytogenes. Consumers should check their refrigerators and discard or return the product.

    Product
    Seasoned Whole Rainbow Trout; by the lb.; seasoned rainbow trout; packaged in an oven ready tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·20V536000·2020-09-02

    Volvo commercial trucks recalled for brake pedal failure risk

    Volvo Trucks is recalling 2020-2021 commercial trucks because the brake pedal may dislodge, making brakes inoperable. Affected models: VHD, VAH, VNL, and VNR.

    Product
    VOLVO — VOLVO VNL, VNR, VAH, VHD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1298-2020·2020-09-02

    Wegmans Recalls Fresh Grilled Shrimp Due to Listeria Risk

    Wegmans is recalling fresh grilled shrimp in 6, 16, and 40-count packages because they may be contaminated with Listeria monocytogenes.

    Product
    Fresh Grilled Shrimp; 6ct, 16ct, 40ct; seasoned grilled shrimp made with EU organic shrimp; packaged in a plastic tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·20V535000·2020-09-02

    2021 Volvo trucks recalled for potentially loose steering king pin nuts

    Volvo Trucks is recalling certain 2021 VHD, VNL, and VNR vehicles because the king pin nut may not have been properly installed during axle assembly, which could cause the axle knuckle to separate and increase crash risk.

    Product
    VOLVO — VOLVO VHD, VNL, VNR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V530000·2020-09-02

    Utilimaster Metris Recall: Incorrect Payload Labeling May Cause Tire Failure

    Shyft Group is recalling 2020 Utilimaster Metris vehicles because the payload capacity on the Tire and Loading Information label may be higher than the actual capacity, increasing the risk of tire failure and crashes.

    Product
    UTILIMASTER — UTILIMASTER METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V533000·2020-09-02

    Volkswagen Recalls 2020 Passat Vehicles Due to Air Bag Defect

    Volkswagen is recalling 2020 Passat vehicles because the passenger air bag may deploy with excessive force, increasing injury risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20175·2020-09-02

    Advantus Recalls Fluorescent Computer Task Lamps Due to Burn Hazard

    Advantus is recalling LEDU Black Fluorescent Computer Task Lamps because internal tape can overheat and melt, posing a burn hazard. One report of smoke was received, with no injuries.

    Product
    LEDU Black Fluorescent Computer Task Lamps Model L283MB
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2837-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1293-2020·2020-09-02

    Wegmans Recalls Chicken Cutlets Due to Listeria Contamination Risk

    Wegmans Food Markets is recalling specific chicken cutlets sold in the Northeast and Mid-Atlantic regions due to potential Listeria monocytogenes contamination.

    Product
    Wegmans Chicken Cutlet; by the lb, in a meal or in a 22 oz. Family Pack; "Heating Instructions: Oven-Preheat to 400 degrees F. Remove chicken from package and place on baking sheet pan. Bake 5-7 minutes. Microwave-Remove label/lid. Heat 2-3 minutes"; Keep Refrigerated; packaged i
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2841-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling 2,550 kits of Trans-Ray 7Fr 34cc Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected devices were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2861-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2892-2020·2020-09-02

    Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Updates

    Karl Storz Endoscopy is recalling 1,246 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid incomplete sterilization.

    Product
    Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2844-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall covers 11,555 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects units distributed worldwide.

    Product
    Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2907-2020·2020-09-02

    Neurovision Cobra x5 EMG ET Tube Recalled for Insulation Softening

    Neurovision is recalling Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.

    Product
    Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2842-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling specific Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2888-2020·2020-09-02

    Siemens Recalls Cios Spin and Cios Alpha X-Ray Systems Due to Hardware Error

    Siemens is recalling 329 Cios Spin and Cios Alpha mobile X-ray systems due to a hardware error affecting the X-ray Generator with an integrated Energy Storage Unit.

    Product
    Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2834-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2897-2020·2020-09-02

    Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

    Karl Storz is recalling 380 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid infection.

    Product
    Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2895-2020·2020-09-02

    Karl Storz Flexible DCI Intubation Fiberscope Recalled for Sterilization Instructions

    Karl Storz Endoscopy is recalling 428 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid incomplete sterilization.

    Product
    Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2836-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 29,653 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2846-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling 3,542 Intra-Aortic Balloon Catheter kits worldwide due to potential endotoxin contamination.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2866-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2867-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2868-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacer Implants Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacer implants because internal components may have been made of stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2865-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2859-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1549-2020·2020-09-02

    Resource Recovery Recalls 70% Hand Sanitizer Due to cGMP Deviations

    Resource Recovery & Trading LLC is recalling 115 bottles of 70% hand sanitizer distributed in Alabama and Georgia due to cGMP deviations.

    Product
    HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2863-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2853-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2840-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall covers kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2881-2020·2020-09-02

    Klarity Vacuum Bags Recalled for Inadequate Vacuum Retention During Radiation Therapy

    Klarity Medical Products LLC is recalling 111 vacuum bags used for patient positioning during radiation therapy because they may not hold a vacuum adequately for the required treatment time.

    Product
    Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2879-2020·2020-09-02

    Ortho VITROS XT7600 System Recalled for Potential Mis-positioned Slides

    Ortho Clinical Diagnostics is recalling VITROS XT7600 Integrated Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.

    Product
    VITROS XT7600 Integrated System, Product code 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2839-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 54,816 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2851-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2857-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2894-2020·2020-09-02

    Karl Storz Flexible DCI Intubation Fiberscope Recall for Sterilization Instructions

    Karl Storz is recalling 463 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.

    Product
    Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2908-2020·2020-09-02

    Neurovision Recalls Cobra x5 2-Ch EMG ET Tubes Due to Insulation Defect

    Neurovision Medical Products Inc is recalling 1,058 Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften, potentially stopping EMG signal transmission.

    Product
    Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2896-2020·2020-09-02

    Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

    Karl Storz Endoscopy is recalling 2,668 flexible intubation video endoscopes to provide updated sterilization instructions and prevent incomplete sterilization.

    Product
    Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2835-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling 32,855 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1304-2020·2020-09-02

    Wegmans Recalls Organic Shrimp Combo Trays Due to Listeria Risk

    Wegmans is recalling Fresh Cooked & Grilled Organic Shrimp Combo Trays because they may be contaminated with Listeria monocytogenes. Consumers should not eat the product.

    Product
    Wegmans Fresh Cooked & Grilled Organic Shrimp Combo Tray; Individual; cooked and grilled shrimp combination with cocktail sauce and lemon; packaged on a plastic tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2852-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2847-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling 3,055 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1307-2020·2020-09-02

    Wegmans Recalls Bay Seasoned Soft Shell Crab Due to Listeria Risk

    Wegmans is recalling Bay Seasoned Soft Shell Crab potentially contaminated with Listeria monocytogenes. Consumers should discard or return the product.

    Product
    Bay Seasoned Soft Shell Crab; Individual; bay seasoned and breaded soft-shell crab; packaged in an oven ready tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2864-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2883-2020·2020-09-02

    GE Healthcare Recalls CARESCAPE R860 Ventilators Due to Oxygen Sensor Issue

    GE Healthcare is recalling 2,277 CARESCAPE R860 ventilators because a potential oxygen sensor issue may cause inaccurate FiO2 readings.

    Product
    CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1315-2020·2020-09-02

    Wegmans Recalls AIP Veggie Pizzas Due to Listeria Contamination Risk

    Wegmans is recalling AIP Veggie Pizzas in several states because they may be contaminated with Listeria monocytogenes.

    Product
    AIP Veggie Pizza; Small, Medium; Large; made to order pizzas; packaged in boxes for takeout; refrigerate
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1309-2020·2020-09-02

    Wegmans Recalls Bronzini Seasoned Fillet Due to Listeria Risk

    Wegmans is recalling Bronzini Seasoned Fillet because it may be contaminated with Listeria monocytogenes. The product was sold in several states in early August 2020.

    Product
    Bronzini Seasoned Fillet; by the lb.; seasoned bronzini fillet with olive oil and lemon; packaged in an oven ready tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1314-2020·2020-09-02

    Wegmans Recalls Store-Made Shrimp Salad Due to Listeria Risk

    Wegmans is recalling store-made shrimp salad sold in several states due to potential Listeria monocytogenes contamination.

    Product
    Shrimp Salad (Made In Store); by the lb.; store made shrimp salad, ready to eat; packaged in a plastic clamshell; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2887-2020·2020-09-02

    Siemens Recalls Cios Alpha and Spin X-Ray Systems for Hardware Error

    Siemens is recalling 329 Cios Alpha and Cios Spin mobile X-ray systems due to a hardware error affecting the X-ray generator after a previous repair.

    Product
    Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2893-2020·2020-09-02

    Karl Storz Flexible Intubation Fiberscope Recall for Sterilization Instructions

    Karl Storz is recalling 650 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid patient infection.

    Product
    Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1257-2020·2020-09-02

    Whole Foods Market Buttermilk Biscuits Recalled for Undeclared Soy Allergen

    Whole Foods Market is recalling Buttermilk Biscuits due to an undeclared soy allergen. The product was sold in six southeastern states.

    Product
    Whole Foods Market Buttermilk Biscuits, 4pk NET WT 1lb 0 oz PLU: 30561 packaged in plastic clam shell
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2843-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2871-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1308-2020·2020-09-02

    Wegmans Soft Shell Crab Recalled for Listeria Contamination Risk

    Wegmans is recalling Ready to Cook Whole Soft Shell Crab with Lemon due to potential Listeria monocytogenes contamination. Consumers should check their refrigerators for this product.

    Product
    Wegmans Ready to Cook Whole Soft Shell Crab with Lemon; 11oz.; whole soft shell crab with lemon; packaged in an oven ready tray; total package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1305-2020·2020-09-02

    Wegmans Ready to Cook Salmon Recalled for Listeria Contamination

    Wegmans is recalling Ready to Cook Salmon with Lemon Pepper Rub due to potential Listeria monocytogenes contamination. Consumers should discard or return the product.

    Product
    Wegmans Ready to Cook Salmon with Lemon Pepper Rub; 6 oz; salmon with lemon pepper rub; packaged in an oven ready tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1295-2020·2020-09-02

    Wegmans Recalls Italian Roasted Salmon Meals Due to Listeria Risk

    Wegmans Food Markets is recalling Italian Roasted Salmon Meals because they are potentially contaminated with Listeria monocytogenes. Consumers should not eat these products.

    Product
    Italian Roasted Salmon Meals; Individual or Family Meals; plastic clamshell, package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1296-2020·2020-09-02

    Wegmans Recalls Chicken Cutlet Meals Due to Listeria Risk

    Wegmans Food Markets is recalling specific chicken cutlet meals because they may be contaminated with Listeria monocytogenes. Consumers should check their refrigerators for affected packages.

    Product
    Chicken Cutlet Meals; Individual or Family Meals; plastic clamshell; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1302-2020·2020-09-02

    Wegmans Recalls Fresh Cooked Shrimp and Crab Claw Tray for Listeria Risk

    Wegmans Food Markets is recalling fresh cooked shrimp and crab claw trays due to potential Listeria monocytogenes contamination. Consumers should not eat the product.

    Product
    Fresh Cooked Shrimp and Crab Claw Tray; Individual; shrimp and crab claw platter with cocktail sauce; packaged in a plastic tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1297-2020·2020-09-02

    Wegmans Recalls Grilled Shrimp Trays Due to Listeria Contamination Risk

    Wegmans is recalling specific grilled shrimp trays sold in six states because they may be contaminated with Listeria monocytogenes.

    Product
    Grilled Shrimp Tray; Individual; Colossal grilled shrimp with sauce; grilled garlic shrimp with cocktail sauce; packaged in a plastic tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1294-2020·2020-09-02

    Wegmans Recalls Chicken French Meals Due to Listeria Risk

    Wegmans Food Markets is recalling Chicken French meals potentially contaminated with Listeria monocytogenes. Consumers should discard or return the product.

    Product
    Wegmans Chicken French; Individual or Family Meals; plastic clamshell; keep refrigerated; size varies
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1303-2020·2020-09-02

    Wegmans Recalls Lobster Claw and Shrimp Platters Due to Listeria Risk

    Wegmans Food Markets is recalling Lobster Claw and Shrimp Platters sold in six states due to potential Listeria monocytogenes contamination.

    Product
    Lobster Claw and Shrimp Platter; Individual; lobster claw and shrimp platter with cocktail sauce and lemon wedge; packaged on a plastic tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1313-2020·2020-09-02

    Wegmans Recalls Crab Cakes Due to Listeria Contamination Risk

    Wegmans is recalling 4oz ready-to-cook crab cakes potentially contaminated with Listeria monocytogenes. Consumers in six states should discard or return the product.

    Product
    Crab Cake; 4oz.; Wegman;s ready to cook signature crab cake; 4oz, 1 each; packaged in a plastic clamshell; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1431-2020·2020-09-02

    A.S.K. Foods Recalls Lobster Salad for Undeclared Allergens

    A.S.K. Foods is recalling Lobster Salad because it may contain undeclared fish, milk, and soy.

    Product
    A.S.K. Foods, Inc. Lobster Salad (2.5 lb.) with codes of 4472 or 4482 , Bulk Containers / 2 Containers per Case ( Product ), SELL BY: 08-28-20
    Category
    Food
    Distribution
    1 state
  • HighCPSC·20176·2020-09-02

    Hanamint Recalls Swivel Rockers and Gliders Due to Fall Hazard

    Hanamint is recalling about 12,000 swivel rockers and gliders because the chair's post can separate from the base, posing a fall hazard.

    Product
    Swivel rocker and glider chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20174·2020-09-02

    IMMI Recalls UTV Harnesses Due to Missing Stitching Injury Hazard

    IMMI is recalling about 162,000 SubZero and Click6 UTV harnesses because missing stitching may prevent proper restraint during a crash. No injuries have been reported.

    Product
    IMMI SubZero 4-point and IMMI Click6 6-point UTV harnesses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1300-2020·2020-09-02

    Wegmans Recalls Assorted Claw Platters Due to Listeria Contamination Risk

    Wegmans is recalling Assorted Claw Platters potentially contaminated with Listeria monocytogenes. Consumers should discard or return the product.

    Product
    Assorted Claw Platter; Individual; Assorted claw platter with cocktail sauce and mustard sauce; packaged on a plastic tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1349-2020·2020-09-02

    Fantis Pita Bread Recalled for Undeclared Milk Allergen

    Fantis Foods is recalling frozen pita bread because the packaging fails to declare milk as an allergen, despite listing whey in the ingredients.

    Product
    Fantis Pita 10 x 7" Pita Bread, 25 oz. 12 per case. Frozen Case lists Fantis Foods 7" Gryo, UPC 00076598772001 Case label properly lists Contains: Wheat, Milk 25 oz. Packages UPC 0 76665 00037 Ingredients: Enriched Wheat Flour (contains Flour, niacin, thiamin Mononitrate,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2833-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling Intra-Aortic Balloon Catheters (IABs) due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2903-2020·2020-09-02

    Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening

    Neurovision is recalling Cobra x5 EMG ET tubes because the insulating material may soften and damage, potentially stopping EMG signal transmission.

    Product
    Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2838-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,746 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2862-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2873-2020·2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS TBIL Slides Due to Etrombopag Interference

    Ortho-Clinical Diagnostics is recalling VITROS TBIL Slides because the drug etrombopag can interfere with test results, potentially leading to inaccurate total bilirubin measurements.

    Product
    VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2845-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling 6,111 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1299-2020·2020-09-02

    Wegmans Recalls Crab Claw Trays Due to Listeria Contamination Risk

    Wegmans Food Markets is recalling Crab Claw Trays because they are potentially contaminated with Listeria monocytogenes. The recall affects units sold in six states.

    Product
    Crab Claw Tray; Tray for 2 or 18; crab claw platter with cocktail sauce; packaged in a plastic tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2890-2020·2020-09-02

    Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Update

    Karl Storz Endoscopy is recalling 91 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of ethylene oxide on specific devices to avoid incomplete sterilization and potential patient infection.

    Product
    Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2878-2020·2020-09-02

    Ortho VITROS XT3400 Chemistry System Recalled for Erroneous Results

    Ortho Clinical Diagnostics is recalling VITROS XT3400 Chemistry Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.

    Product
    VITROS XT3400 Chemistry System, Product code 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2820-2020·2020-09-02

    89 North LDI Laser Firmware Recall for Safety Interlock Defect

    89 North is recalling 188 LDI laser units worldwide due to a firmware defect that allows laser emission to continue when safety interlocks are opened.

    Product
    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2870-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2855-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2860-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2906-2020·2020-09-02

    Neurovision Cobra x5 EMG Endotracheal Tubes Recalled for Insulation Defect

    Neurovision is recalling Cobra x5 EMG endotracheal tubes because the electrode insulation may soften and damage, potentially stopping EMG signal transmission.

    Product
    Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventila
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2891-2020·2020-09-02

    Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

    Karl Storz is recalling 2,083 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.

    Product
    Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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