The Recall Desk

Archive

October 2021 recalls

518 recalls were announced in October 2021.

What the numbers show

Critical
5
Severe
95
High
283
Moderate
132
Low
3

Of the 518 recalls this month scored against our rubric, 1% are Critical, 18% are Severe.

Which agencies issued them

301–400 of 518

  • HighFDA (Devices)·Z-0049-2022·2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recalled for Potential Tubing Leaks

    ZOLL Circulation is recalling 13,935 QUATTRO Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or start-up kit tubing. The affected devices were distributed worldwide, including across all US states.

    Product
    Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2022·2021-10-13

    Centricity Universal Viewer fails to save study changes to archive systems

    GE Healthcare's Centricity Universal Viewer has a software defect where changes to radiological studies are not saved to archive systems, potentially affecting clinician access to current image data.

    Product
    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0037-2022·2021-10-13

    Medical cooler-heater device recalled for inadequate maintenance and inspection guidance

    CardioQuip is recalling 1,646 units of its Modular Cooler-Heater 1000(m) due to inadequate labeling. The device documentation lacks guidance on proper water-quality maintenance and inspection procedures required for safe operation.

    Product
    CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2022·2021-10-13

    Zoll ICY Heat Exchange Catheter Kit Labeling Update Due to Potential Leaks

    ZOLL Circulation is updating labeling for its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 1,256 units distributed worldwide.

    Product
    Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0010-2022·2021-10-13

    Brain MD dietary supplement bottles filled with wrong product

    BrainMD is recalling Brain & Memory Power Boost dietary supplement (120-capsule bottles) because some units were filled with NeuroVite Plus, a different multivitamin-mineral product, instead of the labeled contents.

    Product
    Brain MD - Brain & Memory Power Boost Supports Healthy Brain and Memory Performance 120 capsules - Dietary Supplement UPC: 8 57568 00341 3 Serving Size - 4 capsules' Servings per container - 30 Ingredients - amount per serving: Phosphatidylserine (PS) - 100 mg Acetylcarnitine
    Category
    Consumer Product
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0018-2022·2021-10-13

    Dental implant scan abutment recalled for dimensional tolerance and marking defects

    Paltop Scan Abutment WP dental implant scanning devices are recalled due to manufacturing defects. Affected units show dimensional tolerance deviations and size marking incongruences that may delay restoration procedures.

    Product
    Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2022·2021-10-13

    Zoll ICY Intravascular Catheter Kit: Labeling Update on Potential Leaks

    ZOLL is updating labeling for ICY Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or tubing. Healthcare providers should review updated guidance from the manufacturer.

    Product
    Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0032-2022·2021-10-13

    Beckman Coulter Troponin I Reagent Packs Recalled Due to Sample Contamination

    Beckman Coulter is recalling 293,640 Access hsTnI High Sensitivity Troponin I reagent packs due to sample carryover contamination occurring with very high concentration samples, potentially affecting test accuracy.

    Product
    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-0019-2022·2021-10-13

    OPTETRAK Comprehensive Knee System components recalled for inadequate packaging barrier

    Exactech is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components due to inadequate oxygen barrier in vacuum bag packaging. No injuries have been reported.

    Product
    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0014-2022·2021-10-13

    Scan Abutment NP Dental Implant Components Recalled for Dimensional Deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment NP dental implant components due to manufacturing tolerance deviations that may affect implant restoration fit and timing.

    Product
    Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2022·2021-10-13

    Dental implant abutments recalled for orientation and sizing tolerance issues

    Paltop Advanced Dental Solutions is recalling Scan Abutment SU devices (Catalog No. 30-70104) manufactured before July 21, 2021, due to manufacturing tolerance deviations that may delay dental restoration.

    Product
    Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2022·2021-10-13

    ZOLL Premium Access Kit SOLEX 7 Catheter Kit Labeling Update on Potential Leaks

    ZOLL has issued a labeling update for its Premium Access Kit SOLEX 7 intravascular heat exchange catheter regarding potential leaks from the catheter or tubing. Approximately 5,524 kits were distributed worldwide.

    Product
    ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0038-2022·2021-10-13

    Cardiac Cooler-Heater Device Lacks Maintenance and Inspection Guidance

    CardioQuip is recalling its Modular Cooler-Heater device because labeling omits proper guidance for water-quality maintenance and device inspection, affecting users' ability to maintain the device correctly.

    Product
    CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2022·2021-10-13

    Zoll Cool Line Catheter Kits Recalled Due to Potential Tubing Leaks

    ZOLL Circulation recalls Cool Line (Heparin) IVTM catheter kits due to potential leaks in catheter or start-up kit tubing. The recall affects 144 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2022·2021-10-13

    ZOLL ICY Intravascular Catheter Kit: Labeling Update for Potential Leaks

    ZOLL Circulation recalls 333 units of its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update addresses the leak risk affecting medical facilities worldwide.

    Product
    ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0013-2022·2021-10-13

    Paltop Scan Abutment SP Recalled for Dimensional Tolerance Deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment SP devices due to manufacturing tolerance deviations that may delay dental restoration. Affected devices showed orientation misalignment and size engraving errors.

    Product
    Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2022·2021-10-13

    Orthopedic Knee Implants Lack Protective Oxygen Barrier in Packaging

    Exactech OPTETRAK Comprehensive Knee System inserts were packaged in vacuum bags lacking an additional oxygen barrier layer, which could allow material degradation. The recall affects 2,774 devices distributed worldwide.

    Product
    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0005-2022·2021-10-13

    Meclizine HCl Tablets 25 mg Recalled for Incorrect Instructions

    Rising Pharmaceuticals is recalling Meclizine HCl Tablets 25 mg (Lot # CB21024, expiring 2/2023) due to incorrect labeling instructions on the packaging.

    Product
    Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0043-2022·2021-10-13

    ZOLL SOLEX 7 Intravascular Catheter Kit Labeling Update for Potential Leaks

    ZOLL Circulation, Inc. is updating labeling for SOLEX 7 intravascular heat exchange catheter kits to communicate about potential leaks from the catheter or start-up kit tubing. The update affects 5,345 kits with worldwide distribution.

    Product
    ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0073-2022·2021-10-13

    AngioDynamics NanoKnife Disposable Probes Recalled for Programming Issue

    AngioDynamics is recalling 37 NanoKnife Disposable Single Electrode Probes (Lot 5577754) due to a RFID programming issue that prevents the devices from being recognized by the NanoKnife generator.

    Product
    AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0033-2022·2021-10-13

    Medical Device Calibrator Kit Recall for Incorrect Labeling

    FDA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit due to incorrectly labeled calibrator vials in Lot 00681Y600. The labeling error prevents the instrument from completing calibration successfully.

    Product
    Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2022·2021-10-13

    Scan Abutment PCA dental implant component recalled for tolerance deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment PCA devices due to manufacturing tolerance deviations that may delay implant restoration. Some devices show up to 2-degree orientation variance and sizing discrepancies.

    Product
    Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0022-2022·2021-10-13

    OPTETRAK Comprehensive Knee System Custom Inserts Recalled for Packaging Defect

    Exactech, Inc. is recalling 41 custom OPTETRAK knee implant inserts due to packaging defects. The inserts were packaged in vacuum bags lacking adequate oxygen barrier protection.

    Product
    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0006-2022·2021-10-13

    Mr. Nut Dried Oleaster Recalled for Undeclared Sulfites

    Vintage Food Corp. is recalling Mr. Nut brand Dried Oleaster (10.6 OZ, expiration 10/2022, LOT#20-040) because the product contains undeclared sulfites, which may pose a health risk to sensitive consumers.

    Product
    Mr. Nut brand Dried Oleaster Net Wt: 10.6 OZ (300g). Expiration date 10/2022. UPC 0360894900.
    Category
    Food
    Distribution
    17 states
  • SevereNHTSA·21V792000·2021-10-12

    KTM and Husqvarna Recall Motorcycles for Clutch Slave Cylinder Defect

    KTM North America is recalling specific 2018-2020 KTM and Husqvarna motorcycles because a damaged gasket on the clutch slave cylinder may prevent the clutch from disengaging, increasing crash risk.

    Product
    KTM — KTM, HUSQVARNA 690 ENDURO R, 701 ENDURO LR, 690 DUKE, ENDURO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V793000·2021-10-12

    2019-2022 Winnebago Travato and Boldt RV Electrical Fire Hazard

    Winnebago is recalling 2019-2022 Travato and 2021-2022 Boldt RVs. A faulty wire harness may lose over-current protection, causing wires to overheat and increasing fire risk. Owners must not drive until the Volta Power System is disabled.

    Product
    WINNEBAGO — WINNEBAGO TRAVATO, BOLDT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V790000·2021-10-11

    HME Recalls 2017-2020 Fire Trucks Due to Fuel Rail Leak Risk

    HME is recalling 245 fire trucks from 2017-2020 because a sealing washer may not seat correctly, allowing the high-pressure fuel rail to leak and increasing fire risk.

    Product
    HME — HME, HME AHRENS-FOX 1871, COMMFOX, AERIAL, AF1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V789000·2021-10-11

    Mercedes-Benz Recalls 2021 S-Class Models for Air Bag Software Defect

    Mercedes-Benz is recalling 2021 S 500 and S 580 vehicles because a software defect may deactivate the front passenger air bag, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ S 500, S 580
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V788000·2021-10-09

    Foretravel Recalls 2020-2022 RVs Due to Window Adhesive Failure

    Foretravel is recalling 2020-2022 iH-45, Realm, and iC-37 recreational vehicles because window adhesive may fail, causing the vent to detach and increasing crash risk.

    Product
    FORETRAVEL — FORETRAVEL IH-45, IC-37, REALM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·36-2021·2021-10-08

    Nick’s Famous Bar-B-Q Recalls Smoked Pork for Listeria Risk

    Nick’s Famous Bar-B-Q is recalling approximately 3,140 pounds of ready-to-eat smoked pork barbecue products due to possible Listeria monocytogenes contamination.

    Product
    I-65 BBQ, Inc. — Nick’s Famous Bar-B-Q Recalls Ready-To-Eat Pork Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·21V785000·2021-10-08

    Forest River Recalls 2021-2022 Entrada Motorhomes Due to Brake Line Wear

    Forest River is recalling 2021-2022 Entrada motorhomes because brake lines may wear against leveling jack brackets, potentially causing brake failure and increasing crash risk.

    Product
    EAST TO WEST — EAST TO WEST ENTRADA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V786000·2021-10-08

    Star Trans School Bus Recall for Incorrect Emergency Exit Window Labels

    Forest River is recalling 2014-2016 Star Trans school buses because rear emergency exit window labels are misplaced and incomplete, potentially delaying evacuation.

    Product
    STARTRANS — STARTRANS SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V787000·2021-10-08

    Starcraft Transit Bus Recall for Incorrect Emergency Exit Window Labels

    Forest River is recalling 2012-2016 Starcraft transit buses because rear emergency exit window labels are misplaced and incomplete, potentially delaying evacuation.

    Product
    STARCRAFT BUS — STARCRAFT BUS TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·037-2021·2021-10-08

    Crider Foods Recalls Canned Beef With Gravy Due to Lead Contamination

    Crider Foods is recalling approximately 684,774 pounds of canned beef with gravy products due to possible unsafe levels of lead from a spice mix.

    Product
    Crider, Inc. — Crider Foods Recalls Canned Beef With Gravy Products Due to Possible Unsafe Levels of Lead From Outside Source
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V782000·2021-10-07

    GM Recalls Buick Enclave and Chevrolet Traverse for Air Bag Defect

    General Motors is recalling 2008-2017 Buick Enclave and 2013-2017 Chevrolet Traverse vehicles because the driver's air bag inflator may explode during deployment.

    Product
    BUICK — BUICK, CHEVROLET ENCLAVE, TRAVERSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22701·2021-10-07

    Joovy Zoom 360 Ultralight Jogging Strollers Recalled for Fall Hazard

    Joovy is recalling about 9,200 Zoom 360 Ultralight jogging strollers because the front wheel bearing can fail or detach, creating a fall hazard. The company is offering a free repair kit.

    Product
    Zoom 360 Ultralight jogging strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V783000·2021-10-07

    2022 Tiffin Phaeton Recreational Vehicle Electrical Wiring Defect

    Tiffin Motorhomes is recalling certain 2021-2022 Phaeton recreational vehicles due to an electrical outlet not properly installed during manufacturing, creating an open electrical wire inside the wall that could increase the risk of fire.

    Product
    TIFFIN — TIFFIN PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2582-2021·2021-10-06

    Ultrasound Gel Products Recalled for Possible Bacterial Contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The FDA recommends healthcare providers stop using these products immediately.

    Product
    Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2592-2021·2021-10-06

    Atrium Pneumostat Chest Drain Valve Recalled Following Fatal Preterm Infant Case

    Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.

    Product
    Atrium Pneumostat Chest Drain Valve, Part Number 16100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0008-2022·2021-10-06

    Ruzurgi (amifampridine) Tablets Recalled for Microbial Contamination

    Jacobus Pharmaceutical Company is recalling Ruzurgi (amifampridine) 10 mg tablets due to microbial contamination. Testing found that certain lots exceeded acceptable limits for aerobic bacteria, yeast, and mold.

    Product
    Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-1027-2021·2021-10-06

    Vanilla Flavor Imitation recalled for undeclared allergens and food dyes

    Medina Baking and Powder Products, Inc. is recalling Vanilla Flavor Imitation (White) in 128 fl. oz. gallons due to undeclared egg, Yellow #5, Red #40, and Blue #1. Consumers with allergies or sensitivities to these ingredients face potential health risks.

    Product
    Vanilla Flavor Imitation (White), Net Contents 128 FL. OZS. (1 Gallon)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2577-2021·2021-10-06

    Reperfusion Catheter Recalled Due to Risk of Distal End Fracture

    Imperative Care ZOOM 71 Reperfusion Catheters are recalled due to potential for distal end fracture and detachment. This FDA Class I recall affects units distributed nationwide.

    Product
    Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0897-2021·2021-10-06

    ceFAZolin Injectable Drug Bags Recalled for Lack of Sterility Assurance

    IntegraDose Compounding Services is recalling ceFAZolin 3 G in 0.9% Sodium Chloride injectable bags due to lack of sterility assurance. The recall affects 589 bags distributed to New Hampshire, Massachusetts, and Minnesota.

    Product
    ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0844-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for Benzene Contamination

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 50) due to the presence of benzene contamination. The recall affects 1,437,804 aerosol cans distributed nationwide.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0845-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for Benzene Contamination

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 60+) in 8.5 oz aerosol cans due to the presence of benzene contamination.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2499-2021·2021-10-06

    DeRoyal Procedure Packs with NORMOFLO Warming Sets Recalled for Aluminum Leaching

    DeRoyal procedure packs containing Smiths Medical NORMOFLO warming systems are recalled due to potential aluminum ion leaching into warming fluids. The FDA classified this Class I recall affecting 2880 units distributed in Florida and South Carolina.

    Product
    DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0856-2021·2021-10-06

    Morphine Sulfate Injection Recalled Due to Defective Vials

    Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection because some vials are cracked, which compromises sterility assurance. The affected product was distributed nationwide.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1028-2021·2021-10-06

    Chocolate Flavor Recalled for Undeclared Egg Allergen

    Medina Baking and Powder Products, Inc. is recalling Chocolate Flavor (1 QT) distributed domestically because it contains egg that was not declared on the label. Consumers with egg allergies face a serious health risk.

    Product
    Chocolate Flavor, 1 QT
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·21V779000·2021-10-06

    Mercedes-Benz Recalls 2021 Sprinter Vans for Electrical Fire Risk

    Daimler Vans USA is recalling 2021 Mercedes-Benz Sprinter vans because a cable duct defect may cause an electrical short, increasing the risk of a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 1500, SPRINTER 2500, SPRINTER 3500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1017-2021·2021-10-06

    Velvet Ice Cream Raspberry Fudge Cordial Recalled for Undeclared Allergen

    Velvet Ice Cream Company is voluntarily recalling Velvet Ice Cream Raspberry Fudge Cordial because it contains an undeclared allergen that is not listed on the label.

    Product
    Velvet Ice Cream Raspberry Fudge Cordial 1.75 quarts (56oz) 6 quarts per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2583-2021·2021-10-06

    Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination Risk

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA issued a Class I recall on August 18, 2021.

    Product
    EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2587-2021·2021-10-06

    GENOSYL DS vasodilator console recalled for reversed gas lines defect

    Vero Biotech recalled 3 GENOSYL DS consoles for a manufacturing defect that reverses gas inlet and outlet lines, causing delivery of toxic nitrogen dioxide instead of therapeutic nitric oxide.

    Product
    GENOSYL DS (Delivery System) console, for use as a vasodilator.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0899-2021·2021-10-06

    Testosterone Cypionate/Propionate Injection Recalled for Sterility Assurance

    New Vitalis Pharmacy is recalling Testosterone Cypionate and Testosterone Propionate injections nationwide due to lack of assurance of sterility. The recall affects 1,347 vials distributed across multiple lots.

    Product
    Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0896-2021·2021-10-06

    ceFAZolin Injectable Recalled for Lack of Sterility Assurance

    IntegraDose Compounding Services LLC is recalling ceFAZolin 2 G/20 mL sterile syringes for injection due to lack of sterility assurance. Approximately 2,614 syringes distributed in NH, MA, and MN are affected.

    Product
    ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2518-2021·2021-10-06

    FDA Recalls Ultrasound Gels for Bacterial Contamination Risk

    Omnisound Gel and EcoGel 200 ultrasound gels distributed nationwide from January 2018 to August 2021 may contain bacterial contamination. The FDA issued a Class I recall; health care providers should immediately stop using these products.

    Product
    Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2021·2021-10-06

    Corin BIOLOX Delta Mod Head hip implant components recall due to packaging damage

    Corin Ltd is recalling Corin BIOLOX Delta Mod Head hip implant components due to packaging system damage that could result in loss of sterility or device contamination. Affected units were distributed nationwide to nine states.

    Product
    Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2021·2021-10-06

    Anesthesia Flow Sensors Recalled for Tube Damage and Potential Gas Leaks

    GE Healthcare is recalling approximately 310,000 replacement flow sensors for anesthesia machines manufactured before June 2021. The sensors may have damaged tubes that leak, causing incorrect anesthesia delivery to patients.

    Product
    Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V777000·2021-10-06

    2021 Aluma trailers recalled for loose mounting bracket on trailer bed

    Aluma KLM recalls 2021 Aluma trailers for loose front latch rivet nuts that may cause the mounting bracket to disengage, tilting the trailer bed unexpectedly and increasing crash risk. Dealers will install replacement hardware free of charge.

    Product
    ALUMA — ALUMA ALUMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22003·2021-10-06

    ElliptiGO Arc Bicycles Recalled for Structural Frame Failure Risk

    ElliptiGO Arc bicycles are being recalled because the aluminum frame can break while riding, creating a fall hazard. Six minor injuries have been reported so far.

    Product
    ElliptiGO Arc bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2021·2021-10-06

    Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery

    B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.

    Product
    Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2021·2021-10-06

    LYMOL Medical Elite X Class Rigid Bronchoscope System — Updated reprocessing instructions not distributed

    Lymol Medical Corporation recalled the LYMOL Medical Elite X Class Rigid Bronchoscope System because updated reprocessing instructions issued November 15, 2020, were not sent to all consignees of the devices.

    Product
    LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V780000·2021-10-06

    Nexus Recalls 2018-2020 RVs Due to Gas Leak Risk in Stoves

    Nexus is recalling 2018-2020 recreational vehicles because a stove component may cause a gas leak, increasing fire risk.

    Product
    NEXUS — NEXUS EVOQUE, BENTLEY DIAMOND, BENTLEY, WRAITH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2021·2021-10-06

    Dose Calibrator Software Bug May Cause Incorrect Isotope Measurements

    AtomLab 500Plus Dose Calibrator software versions 2.0.00–2.0.08 contain a bug that fails to remove dial settings when deleting custom isotopes, potentially causing incorrect dose calibrations and misadministration.

    Product
    AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2021·2021-10-06

    Vascutek Vascular Grafts Recalled for Incorrect Instructions for Use

    Vascutek is recalling vascular grafts distributed to Puerto Rico and Guam that contained wrong Instructions for Use prepared for international rather than U.S. consignees. Improper instructions pose a risk of incorrect device use.

    Product
    The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthe
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2609-2021·2021-10-06

    Corin MetaFix Hip Stem Recalled Due to Potential Packaging Damage

    Corin Ltd is recalling Corin MetaFix Hip Stem, Size 1 devices due to potential physical and water damage to packaging that could compromise device sterility and cause contamination.

    Product
    Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2589-2021·2021-10-06

    Atrium ADVANTA VXT Vascular Graft may lack required radial support ring

    Atrium Medical Corporation is recalling 28 units of the Atrium ADVANTA VXT Vascular Graft because some packages may contain mismatched units lacking the radial support ring specified in labeling.

    Product
    Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2555-2021·2021-10-06

    B. Braun Pump Set Cassette Leakage Risks Medication Delivery

    B. Braun Medical recalls 13,320 pump sets due to cassette leakage that may delay medication administration and cause incomplete dosing or bloodstream infections.

    Product
    PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2021·2021-10-06

    Atomlab 500 Dose Calibrator Software Recall for Incorrect Dose Measurement

    Biodex Medical Systems is recalling Atomlab 500 Dose Calibrator Software versions 2.0.00 through 2.0.08 due to a software defect that can cause incorrect dose measurements and potential misadministration of radioactive material.

    Product
    Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2591-2021·2021-10-06

    MOSAIQ Oncology Information System software defect reverts approved drug strength

    The MOSAIQ Oncology Information System has a software defect where approved changes to drug strength revert to the original value when saved, potentially resulting in incorrect medication dosages.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2575-2021·2021-10-06

    NAMIC Stopcocks Recalled Due to Potential Sterile Barrier Breach

    Medline Industries is recalling NAMIC Stopcocks due to potential sterile barrier breaches from microscopic pinholes in sterile pouches, which could allow non-sterile conditions.

    Product
    NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2021·2021-10-06

    Corin TriFit TS Orthopedic Implant Recall Due to Packaging Damage and Sterility Loss

    Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US states.

    Product
    Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2549-2021·2021-10-06

    Outlook Pump Measured Volume Solution Set recalled for cassette leakage

    B. Braun is recalling 940 units of Outlook Pump Measured Volume Solution Sets due to potential leakage in the cassette. The leakage could delay medication delivery, result in incomplete dosing, or lead to bloodstream infections.

    Product
    Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2021·2021-10-06

    B. Braun Infusion Pump Sets Recalled for Leakage and Infection Risk

    B. Braun Medical's infusion pump sets may leak, potentially delaying medication delivery and causing incomplete dosing. The defect poses a risk of bloodstream infections.

    Product
    15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2602-2021·2021-10-06

    DxA 5000 Automation System Recalled Due to Sample Containment Defect

    Beckman Coulter is recalling 123 DxA 5000 automation systems due to a sample containment defect that may cause samples to drop, delaying patient treatment and risking biohazard exposure. Affected units were distributed to eleven states.

    Product
    DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2021·2021-10-06

    Olympus BF-3C40 OES Bronchofiberscope Recall: Reprocessing Instructions Updated

    Olympus is recalling approximately 484 BF-3C40 OES Bronchofiberscopes due to reprocessing instruction updates. The manufacturer is issuing validated instructions per FDA 2015 guidance for proper device reprocessing.

    Product
    BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2601-2021·2021-10-06

    Patient lift devices may lose ability to maintain horizontal positioning during transfers

    Hill-Rom LikoStretch Mod 600 IC patient lift devices may fail to maintain patients in a horizontal position while lifting, potentially causing patients to slide or fall.

    Product
    LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2021·2021-10-06

    Outlook Pump Primary Administration Set Recalled for Potential Leakage and Medication Underdosing

    B. Braun Medical is recalling the Outlook Pump Primary Administration Set due to potential leakage that could delay medication delivery and cause incomplete dosing of critical fluids in epidural administration.

    Product
    Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2021·2021-10-06

    B. Braun Outlook Pump Set 3 Recalled for Leakage and Medication Delivery Delays

    B. Braun Medical is recalling 768 units of Outlook Pump Set 3 infusion sets due to potential leakage that could delay or prevent complete medication delivery and increase risk of bloodstream infection.

    Product
    OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2021·2021-10-06

    Operating Room Table Rotational Lock May Fail Due to Hardware Defect

    The rotational locking mechanism on certain ORT200/300 operating room tables may fail to lock or unlock due to a mechanical hardware defect. Affected tables have been distributed worldwide.

    Product
    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2552-2021·2021-10-06

    B. Braun Outlook IV Pump Sets Recalled Due to Leakage Risk

    B. Braun Medical is recalling Outlook pump IV sets used with specific infusion pumps due to leakage in the cassette portion. The defect may prevent proper medication delivery and pose a risk of bloodstream infection.

    Product
    OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2576-2021·2021-10-06

    Vysis CLL FISH Probe Kit may fail to detect genetic deletion

    Abbott is recalling Vysis CLL FISH Probe Kits that may not detect 13q deletions in patient samples. This could lead to missed diagnosis of a genetic abnormality used in cancer treatment planning.

    Product
    Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2021·2021-10-06

    B. Braun Outlook Pump Set Recall: Risk of Leakage and Medication Under-Delivery

    B. Braun is recalling 1,752 Y-Type Blood Outlook Pump Set units due to leakage in the cassette portion. The defect may cause delays in medication administration, incomplete dosing, or bloodstream infections.

    Product
    Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2547-2021·2021-10-06

    B. Braun Infusion Pump Sets Recalled Due to Cassette Leakage Risk

    B. Braun Medical is recalling 1,960 infusion pump sets used with Outlook Safety and Horizon NXT systems due to leakage in the cassette portion, which may delay medication delivery and increase bloodstream infection risk.

    Product
    60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2021·2021-10-06

    Blood Administration Pump Set Recalled Due to Leakage Risk

    B. Braun Medical is recalling Outlook Pump Blood Administration Sets due to leakage in the pump cassette that could delay or prevent complete medication delivery and increase infection risk.

    Product
    Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2548-2021·2021-10-06

    Infusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk

    B. Braun Medical is recalling infusion pump sets that may leak, potentially causing delayed medication delivery, incomplete dosing, and bloodstream infections.

    Product
    10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2612-2021·2021-10-06

    Corin Unity Knee Patella components recalled due to packaging damage

    Corin is recalling Corin Unity Knee Patella components due to potential packaging damage that could compromise sterility and device integrity. Affected units were distributed in nine US states in July 2021.

    Product
    Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2604-2021·2021-10-06

    Corin Trinity Bone Screws Recalled for Potential Packaging Damage and Sterility Loss

    Corin Ltd is recalling specific lots of Trinity Acetabular System bone screws due to potential packaging damage that could result in loss of sterility or device contamination.

    Product
    Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2021·2021-10-06

    Bronchovideoscope Reprocessing Instructions Updated for Sterilization Compliance

    Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.

    Product
    BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2579-2021·2021-10-06

    PAS-PORT Proximal Anastomosis Device recalled for deployment failure risk

    Aesculap Implant Systems is recalling the PAS-PORT Proximal Anastomosis Device because the implant may fail to deploy successfully, potentially requiring additional medical intervention during surgery.

    Product
    PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2021·2021-10-06

    Mobile X-Ray System Recalled for Unexpected Column Motion During Parking

    GE Healthcare is recalling the AMX Navigate Mobile X-Ray System due to an unexpected column motion defect that occurs during parking operations. Three units distributed in the United States are affected.

    Product
    AMX Navigate Mobile X-Ray System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2597-2021·2021-10-06

    Patient lift device may lose horizontal positioning control, creating fall risk

    The OctoStretch with Stretch Leveller may lose its ability to keep patients horizontal during lifting, risking patient falls. 440 units were distributed worldwide.

    Product
    OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2021·2021-10-06

    Outlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk

    B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially causing bloodstream infections.

    Product
    OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2545-2021·2021-10-06

    B. Braun Outlook Pump Sets recalled for potential leakage and infection risk

    B. Braun is recalling 585,576 Outlook Pump Sets due to potential leakage in the cassette portion. The defect may cause medication under-delivery and increase bloodstream infection risk.

    Product
    Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2550-2021·2021-10-06

    Outlook pump extension sets recalled due to leakage and dosing errors

    Outlook infusion pump extension sets may leak, potentially delaying medication delivery and causing bloodstream infections.

    Product
    ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2021·2021-10-06

    Operating room table rotational lock may fail to maintain position

    The rotational lock on certain operating room tables may fail to secure the table position. This could cause the table to move unexpectedly during diagnostic or surgical procedures.

    Product
    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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