The Recall Desk

Archive

February 2020 recalls

815 recalls were announced in February 2020.

What the numbers show

Critical
88
Severe
191
High
354
Moderate
163
Low
19

Of the 815 recalls this month scored against our rubric, 11% are Critical, 23% are Severe.

Which agencies issued them

301–400 of 815

  • SevereFDA (Devices)·Z-1111-2020·2020-02-19

    Terumo Advanced Perfusion Assembly Pump Guts Recalled for Potential Shaft Failure

    Terumo is recalling 11 Advanced Perfusion Assembly Pump Guts units because pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualifi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1209-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Sets

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1116-2020·2020-02-19

    Teleflex Recalls Rusch Greenlite Laryngoscope Blades Due to Breakage Reports

    Teleflex Medical is recalling Rusch Greenlite Single-Use Metal Laryngoscope Blades because they may break at a welded joint during setup or use.

    Product
    Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1166-2020·2020-02-19

    Pacific Medical Toco+ Transducers Recalled for Unverified Service Components

    Pacific Medical Group is recalling 2,170 Toco+ transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal/maternal monitoring and patient burns.

    Product
    Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1206-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Sets

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Drugs)·D-0846-2020·2020-02-19

    Rompe Pecho EX Expectorant Recalled for Microbial Contamination

    Efficient Laboratories, Inc. is recalling 5,387 bottles of Rompe Pecho EX Expectorant due to microbial contamination. Consumers should stop using the product and return it to the place of purchase.

    Product
    Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0839-2020·2020-02-19

    Akorn Recalls Subpotent Hydrocortisone and Acetic Acid Otic Solution

    Akorn Inc is recalling 16,078 bottles of Hydrocortisone and Acetic Acid Otic Solution due to low assay results for the hydrocortisone component.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1171-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Sets

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E
    Category
    Medical Device
    Distribution
    37 states
  • HighCPSC·20074·2020-02-19

    Contigo Recalls 5.7 Million Kids Water Bottles Due to Choking Hazard

    Contigo is reannouncing a recall of 5.7 million kids water bottles because the clear silicone spout can detach, posing a choking hazard to children.

    Product
    Contigo Kids Cleanable Water Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms.

    Product
    Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2020·2020-02-19

    Blue Ortho TKA Pro Software Recalled for Incorrect Navigation Data

    Blue Ortho is recalling TKA Pro v2.1 software installed on the Exactech GPS system because it displays incorrect navigated values due to software inconsistencies.

    Product
    Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1109-2020·2020-02-19

    Terumo Advanced Perfusion System 1 Roller Pump Recall for Shaft Failure

    Terumo is recalling 106 Advanced Perfusion System 1 Roller Pumps because the pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a quali
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1154-2020·2020-02-19

    Respironics Ventilator Touchscreen Recall Due to Unresponsive Controls

    Respironics is recalling V60/V680 ventilator touchscreens that may freeze and fail to respond to touch commands, potentially delaying necessary therapy adjustments.

    Product
    Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V095000·2020-02-19

    BMW Recalls 2020 X6 Models Due to Rear Spoiler Detachment Risk

    BMW is recalling 2020 X6 vehicles because the rear spoiler may detach while driving, creating a road hazard and increasing the risk of a crash.

    Product
    BMW — BMW X6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220
    Category
    Medical Device
    Distribution
    37 states
  • HighNHTSA·20V094000·2020-02-19

    BMW Recalls 2014-2019 M6 Gran Coupe for Loose Third Brake Light

    BMW is recalling 2014-2019 M6 Gran Coupe vehicles because the third brake light may detach, creating a road hazard and reducing visibility for following traffic.

    Product
    BMW — BMW M6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V093000·2020-02-19

    Audi Recalls 2019 Q7 Models Due to Side Air Bag Defect

    Volkswagen is recalling 2019 Audi Q7 vehicles because side curtain air bags may not inflate properly in a crash, increasing injury risk.

    Product
    AUDI — AUDI Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2020·2020-02-19

    Terumo AZUR CX Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 3,881 units of the Terumo AZUR CX Peripheral Coil System because the devices may be missing the implant coil.

    Product
    Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, M
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1123-2020·2020-02-19

    Flowonix US Clinical 20mL Programmable Pump Recall for Firmware Alarm Defect

    Flowonix Medical Inc is recalling US Clinical 20mL Programmable Pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2020·2020-02-19

    Terumo AZUR Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 445 units of Terumo AZUR Peripheral Coil Systems because the implant coil may be missing from the device.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420, 45
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1124-2020·2020-02-19

    Flowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2020·2020-02-19

    Ortho VITROS Chemistry Calibrator Kit 2 Recalled for Potential Sodium Bias

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 units due to a potential for negatively biased sodium (Na+) urine results.

    Product
    VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms for valve system issues.

    Product
    Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Sets

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1225-2020·2020-02-19

    Terumo AZUR CX Peripheral Coil System Recalled for Missing Implant Coil

    Microvention is recalling 1,187 units of Terumo AZUR CX Peripheral Coil Systems because the implant coil may be missing from the packaging.

    Product
    Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, Sterile, Rx. The fi
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1155-2020·2020-02-19

    Respironics V680 Ventilator Recalled for Unresponsive Touchscreen

    Respironics is recalling 190 V680 Ventilators because the touchscreen may freeze, preventing clinicians from adjusting therapy settings and potentially causing delayed treatment.

    Product
    Respironics V680 Ventilator, Service # 850011, (OUS Only)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2020·2020-02-19

    Philips VesselNavigator Software Recall for DSA Display Defect

    Philips is recalling VesselNavigator software due to a defect that displays digital subtraction angiography images without subtraction.

    Product
    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extension
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2020·2020-02-19

    Medtronic MiniMed 670G System Recalled for Loose Insulin Reservoir

    Medtronic is recalling MiniMed 670G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

    Product
    Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1110-2020·2020-02-19

    Terumo Advanced Perfusion Assembly Pump Guts Recalled for Potential Shaft Failure

    Terumo is recalling 16 Advanced Perfusion Assembly Pump Guts units because the pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical prof
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2020·2020-02-19

    Flowonix Prometra Programmable 20mL Pump Recalled for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL Pumps because a firmware anomaly may prevent the device from sending error notifications or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2020·2020-02-19

    Implant Direct Sybron Recalls Dental Implants With Incorrect Color Coding

    Implant Direct Sybron Manufacturing LLC is recalling 11 dental implant units because the vial and cap colors did not match the implant size, potentially causing surgical delays or infection risks.

    Product
    SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0957-2020·2020-02-19

    Medtronic MiniMed 620G Insulin Pump Recall for Loose Reservoirs

    Medtronic is recalling MiniMed 620G insulin pumps not distributed in the US due to a loose reservoir that may cause incorrect insulin delivery.

    Product
    Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1152-2020·2020-02-19

    Respironics V60 Ventilator Recalled for Frozen Touchscreen Failure

    Respironics is recalling 2,851 V60 Ventilators because the touchscreen may freeze, preventing clinicians from adjusting therapy settings. This could delay necessary changes, potentially leading to hypercarbia or hypoxemia.

    Product
    Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2020·2020-02-19

    Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues

    Stryker is recalling 87 Omega 4.75 mm PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.

    Product
    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1221-2020·2020-02-19

    MicroVention AZUR Peripheral Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 107 units of the AZUR Peripheral Coil System because the implant coil may be missing from the sterile packaging.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0955-2020·2020-02-19

    Medtronic MiniMed 630G System Recalled for Loose Reservoir Defect

    Medtronic is recalling MiniMed 630G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

    Product
    Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1150-2020·2020-02-19

    Medtech ROSA Brain 3.0 Software Recalled for Image Reconstruction Errors

    Medtech SAS is recalling ROSA Brain 3.0 software because cross-sectional images may not display properly, potentially compromising surgery planning.

    Product
    ROSA Brain 3.0 Application-Brain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0930-2020·2020-02-19

    Tytek Medical Recalls PneumoDart Devices Due to Occluded Needle Defect

    Tytek Medical Inc is recalling 3,565 PneumoDart devices because a defect involving an occluded needle was discovered during a training exercise.

    Product
    PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0683-2020·2020-02-19

    Meijer Recalls Diced Hard-Boiled Eggs Due to Possible Listeria Contamination

    Meijer is recalling diced hard-boiled eggs sold at two Michigan stores due to possible Listeria monocytogenes contamination.

    Product
    Fresh From Meijer diced hard boiled eggs sold by weight from the salad bar area in clear plastic clamshell PLU 8505, UPC 0-0-8505-2
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0740-2020·2020-02-19

    Ready Pac Bistro Spinach Dijon Salad Recalled for Undeclared Allergens

    Ready Pac Foods is recalling Spinach Dijon Salad because the label fails to declare eggs and wheat.

    Product
    Ready Pac Bistro - Spinach Dijon Salad with Sweet Onion Dijon Vinaigrette; Baby Spinach, Hard Boiled Eggs, Monterey Jack-Colby Cheese, Crispy Noodles, Almonds, Dried Cranberries with Sweet Onion Dijon Vinaigrette. Net Wt. 4.75 oz. (135 g). UPC: 0 77745 29795 8 Distributed
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0679-2020·2020-02-19

    Worldwide Seafood Products Recalls Tidal Seafood Yellowfin Tuna for Histamine Levels

    Worldwide Seafood Products LLC is recalling Tidal Seafood Yellowfin Tuna due to potentially elevated histamine levels. The product was distributed domestically to one consignee.

    Product
    103200 - TIDAL SEAFOOD YELLOWFIN TUNA 10 lb, 2x10 lb cases and 103205 - TIDAL SEAFOOD YELLOWFIN TUNA 10 lb, 2x10 lb packed by Truong Phu Xanh Co. Ltd., in Vietnam
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1112-2020·2020-02-19

    Teleflex Medical Recalls Hudson RCI Comfort Flo Humidifier Nebulizer Kits

    Teleflex Medical is recalling 30,566 Hudson RCI Comfort Flo humidifier nebulizer kits because water may flood the column and enter the circuit during high-flow oxygen therapy.

    Product
    HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2020·2020-02-19

    Teleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems

    Teleflex Medical is recalling 60,467 Hudson RCI Comfort Flo Corrugated Humidification Systems because water may flood the column and enter the circuit during high-flow oxygen therapy.

    Product
    HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0684-2020·2020-02-19

    Kerry Recalls DaVinci Caramel Sauce Due to Undeclared Milk Allergen

    Kerry, Inc. is recalling DaVinci Gourmet Classic Caramel Flavored Sauce because an incorrect label failed to declare milk as an ingredient.

    Product
    DaVinci Gourmet, Classic Caramel Flavored Sauce, 128 FL OZ (1 GAL), in plastic jugs
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1104-2020·2020-02-19

    Dexcom G6 CGM App iOS Software Recall for Low Alarm Defect

    Dexcom Inc is recalling the Dexcom G6 CGM App for iOS due to a software defect that may prevent low blood glucose alarms from triggering correctly.

    Product
    Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1107-2020·2020-02-19

    bioMerieux Recalls VIDAS Varicella Zoster IgG Antibody Test Kits

    bioMerieux is recalling VIDAS Varicella Zoster IgG antibody kits due to potential invalid calibrations or false positive results.

    Product
    VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0834-2020·2020-02-19

    Zydus Recalls Ethacrynate Sodium Injection Vials Due to cGMP Deviations

    Zydus Pharmaceuticals is recalling 2,207 vials of Ethacrynate Sodium for Injection due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1182-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1103-2020·2020-02-19

    Fridababy SmileFrida ToothHugger Recalled Due to Potential Metal Exposure

    Fridababy LLC is recalling SmileFrida ToothHugger toothbrushes because repeated chewing may cause the plastic head to break, exposing a small internal metal piece.

    Product
    fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2020·2020-02-19

    Terumo AZUR Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 19 units of Terumo AZUR Peripheral Coil Systems because the implant coil may be missing from the device.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1106-2020·2020-02-19

    Cardiac Assist Recalls TandemLife ECLS Procedure Kits with Incorrect Cannula

    Cardiac Assist, Inc. is recalling 11 TandemLife ECLS Procedure Kits that contained a 29Fr ProtekDuo cannula instead of the intended 24Fr Protek Solo Venous cannula.

    Product
    TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Defect

    Flowonix Medical Inc is recalling Prometra II 40mL implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1147-2020·2020-02-19

    Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues

    Stryker is recalling 73 Omega PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.

    Product
    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1169-2020·2020-02-19

    DePuy Orthopaedics Recalls Specialist 2 Distal Femoral Cutting Blocks

    DePuy Orthopaedics is recalling 140 Specialist 2 Distal Femoral Cutting Blocks because they will not connect to the required outrigger, rendering them unusable in surgery.

    Product
    SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0996-2020·2020-02-19

    Theraflu Cough Relief Recalled for Missing Sodium Warning

    GSK is recalling Theraflu Cough Relief packets because the label lacks a warning for people on sodium-restricted diets.

    Product
    Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1158-2020·2020-02-19

    Roche Recalls cobas infinity core Software Due to Display Error

    Roche Diagnostics is recalling cobas infinity core software modules because alarm flags with a '<' symbol are not displayed on the Validation screen.

    Product
    cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1146-2020·2020-02-19

    Revanesse Versa Recalled for Incorrect Expiration Date Labeling

    Prollenium Medical Technologies is recalling 48,457 kits of Revanesse Versa because the product is labeled with an 18-month expiration date, but it is only approved for 12 months.

    Product
    Revanesse Versa, PN40081
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1228-2020·2020-02-19

    CooperVision Vertex Toric Contact Lenses Recalled for Incorrect Power

    CooperVision is recalling specific lots of Vertex Toric contact lenses because they were manufactured with an incorrect power.

    Product
    Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2020·2020-02-19

    CooperVision Vertex Toric Contact Lenses Recalled for Incorrect Power

    CooperVision is recalling 216 units of Vertex Toric contact lenses because they have an incorrect power than expected.

    Product
    Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0841-2020·2020-02-19

    Pfizer Recalls Caduet Tablets Due to Defective Bottle Seals

    Pfizer is recalling 141 bottles of Caduet tablets because defective bottle rims may have allowed moisture to enter, potentially compromising the medication.

    Product
    CADUET — CADUET (AMLODIPINE AND ATORVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2020·2020-02-19

    LivaNova Recalls Six VNS Therapy SENTIVA Generators for Sterilization Error

    LivaNova USA Inc is recalling six VNS Therapy SENTIVA Generator Model 1000 units because they were sterilized one additional cycle, failing to meet quality specifications.

    Product
    VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1157-2020·2020-02-19

    Implant Direct Legacy 3 Implants Recalled for Incorrect Cover Screws

    Implant Direct is recalling 78 Legacy 3 dental implants because some packages contain incorrect cover screws and extenders, which may delay surgery or require new procedures.

    Product
    Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-0855-2020·2020-02-19

    Lupin Recalls Memantine Hydrochloride Capsules for Dissolution Failure

    Lupin Pharmaceuticals is recalling 6,294 bottles of Memantine Hydrochloride Extended Release Capsules because they failed to meet dissolution specifications during stability testing.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1219-2020·2020-02-19

    Bard Intra-abdominal Pressure Monitoring Device Recalled for Potential Leaks

    C.R. Bard Inc. is recalling 1,300 units of the Bard Intra-abdominal Pressure Monitoring Device due to leaks or disconnects that may cause inaccurate readings.

    Product
    The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0682-2020·2020-02-19

    Morton Salt Canisters Recalled for Mislabeling Iodized Salt as Plain Salt

    Morton Salt Inc. is recalling 26 oz canisters of iodized salt that were incorrectly labeled as plain salt, resulting in undeclared dextrose and potassium iodide.

    Product
    MORTON SALT;THIS SALT DOES NOT SUPPLY IODIDE; 26 oz (1LB., 10 OZ) 737 g; packed in 24 canisters per case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0842-2020·2020-02-19

    Pfizer Recalls Caduet Tablets Due to Defective Bottle Seals

    Pfizer is recalling 128 bottles of Caduet (amlodipine and atorvastatin) because defective bottle rims may have caused inadequate foil sealing, potentially compromising moisture protection.

    Product
    CADUET — CADUET (AMLODIPINE AND ATORVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1127-2020·2020-02-19

    Nextremity Solutions Recalls Stratum Lapidus Plate Due to Labeling Error

    Nextremity Solutions is recalling 40 Stratum Lapidus Plate units because the package labeling indicates a right plate, but the product contains a left plate.

    Product
    Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Food)·F-0736-2020·2020-02-19

    Sugar Foods Recalls Granulated Pure Cane Sugar Due to Foreign Material

    Sugar Foods Corporation is recalling specific lots of granulated pure cane sugar sold under Ahold, N'Joy, and Speedway brands because the product may be contaminated with foreign material.

    Product
    Granulate Pure Cane Sugar sold under the brand names of: Ahold 16 oz canister, DISTRIBUTED BY FOODHOLD USA, LLC, LANDOVER, MD 20758 UPC 6 88267 08529 1; N'Joy 22 oz canister, SUGAR FOODS CORPORATION NEW YORK, NY 10022, UPC 0 86631 00698 7; Speedway 22oz canister, DISTRI
    Category
    Food
    Distribution
    17 states
  • LowFDA (Devices)·Z-1119-2020·2020-02-19

    LivaNova Sorin Connect Datapad Recall for Incorrect Manufacturing Date Labels

    LivaNova USA Inc. is recalling five Sorin Connect Datapad devices because they have incorrect manufacturing date labels. The devices were distributed in New Jersey and California.

    Product
    LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-0843-2020·2020-02-19

    Par Pharmaceutical Recalls Frovatriptan Tablets Due to Incorrect Expiration Date

    Par Pharmaceutical is recalling 9,936 cartons of Frovatriptan Succinate Tablets, 2.5mg, because they are labeled with an incorrect expiration date.

    Product
    Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1229-2020·2020-02-19

    Taewoong Esophageal Stents Recalled Due to Misprinted Instructions for Use

    Taewoong Medical Co., Ltd. is recalling 178 esophageal stents because the Instructions for Use (IFUs) shipped with the devices were misprinted.

    Product
    Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·20V091000·2020-02-17

    Jayco Recalls Fifth Wheel Trailers Due to Underrated Axles

    Jayco is recalling 2013-2015 Fifth Wheel Seismic and 2015 Pinnacle trailers because they were built with 6,000lb axles instead of the intended 7,000lb axles.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL, JAYCO SEISMIC, PINNACLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V090000·2020-02-14

    Mercedes-Benz Recalls G 550 and AMG G63 for Stability Control Defect

    Mercedes-Benz is recalling 2019-2020 G 550 and AMG G63 vehicles because a faulty electrical resistor may deactivate Electronic Stability Program and Anti-lock Brake System.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ G 550, AMG G63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V088000·2020-02-14

    Kia Recalls Sedona and Sorento Models for ABS Module Fire Risk

    Kia is recalling 2006-2010 Sedona and 2007-2009 Sorento vehicles because moisture in the ABS module can cause an electrical short and engine compartment fire.

    Product
    KIA — KIA SEDONA, SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V089000·2020-02-14

    Mercedes-Benz Recalls Vehicles for Instrument Cluster Software Defect

    Mercedes-Benz is recalling specific 2020-2021 models because instrument cluster software may deactivate interior switch illumination, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450, CLA 250, GLS450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V080000·2020-02-13

    RAM Recalls 2019 1500 Trucks for Transfer Case Defect

    Chrysler is recalling 2019 Ram 1500 4WD trucks because a transfer case gear may be installed incorrectly, potentially causing a sudden loss of power or loss of the Park function.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V085000·2020-02-13

    Vermeer Recalls Brush Chipper Trailers Due to Lug Nut Defect

    Vermeer is recalling certain 2016-2020 brush chipper trailers because incorrect lug nuts may loosen, potentially causing the wheel to detach or loss of control.

    Product
    VERMEER — VERMEER BC1500, BC1000XL, BC1200XL, AX19
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20073·2020-02-13

    Textron Recalls Gas-Powered Off-Road Vehicles Due to Fire Hazard

    Textron Specialized Vehicles is recalling approximately 20,573 gas-powered E-Z-GO, Cushman, and Tracker off-road vehicles because a starter generator wire can contact the exhaust, posing a fire hazard.

    Product
    Gas-powered E-Z-GO, Cushman and Tracker brand off-road vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V083000·2020-02-13

    BMW Recalls 2019 C 400 X Scooters for Throttle Cable Defect

    BMW is recalling 2019 C 400 X scooters because water in the throttle cable can freeze, causing the throttle to stick and increasing crash risk.

    Product
    BMW — BMW C 400 X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V084000·2020-02-13

    Heartland Recalls 2020 Fifth Wheel Trailers Due to Smoke Detector Placement

    Heartland is recalling 487 fifth wheel trailers because a smoke detector may be incorrectly located in the bedroom, potentially delaying fire warnings.

    Product
    HEARTLAND — HEARTLAND MILESTONE, PIONEER, BIGHORN TRAVELER, ELKRIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V081000·2020-02-13

    Jaguar Recalls 2010 XF Vehicles Due to Fuel Leak Fire Risk

    Jaguar is recalling 2010 XF vehicles with 4.2L engines because a cracked fuel tank outlet flange may leak fuel, increasing fire risk.

    Product
    JAGUAR — JAGUAR XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0575-2020·2020-02-12

    Catsmo and Related Brands Recalled for Listeria Contamination

    Catsmo LLC is recalling approximately 3,800 lbs of smoked salmon products due to potential Listeria monocytogenes contamination. The products were distributed in 11 states and Washington D.C.

    Product
    Catsmo brand Gold (sliced, whole, 4oz); Scottish (Whole, Sliced, Whole No Skin, 1lb, 4oz); Loin; Organic (4oz); Double Smoked (4oz); Irish (4oz); Wallkill Farms brand Nova (Sliced, Whole); Daniel Boulud brand sliced; First Course brand sliced smoked salmon products manufactured o
    Category
    Food
    Distribution
    11 states

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