The Recall Desk

Archive

December 2018 recalls

451 recalls were announced in December 2018.

What the numbers show

Critical
15
Severe
134
High
189
Moderate
96
Low
17

Of the 451 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.

1–100 of 451

  • SevereNHTSA·18V944000·2018-12-31

    Arcimoto Recalls 2018 FUV Motorcycles Due to Transmission Defect

    Arcimoto is recalling 2018 FUV motorcycles because incorrect machining of the transmission case may cause premature gearbox failure, potentially immobilizing the vehicle and increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V937000·2018-12-31

    Arcimoto Recalls 2017 FUV Motorcycles Due to Brake System Defect

    Arcimoto is recalling 2017 FUV motorcycles because the brake system design may fail to meet federal stopping distance requirements, increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V940000·2018-12-31

    Arcimoto Recalls 2017 FUV Motorcycles Due to Brake Fitting Defect

    Arcimoto is recalling 2017 FUV motorcycles because incorrect fittings in the braking system may cause fluid leaks, reducing brake effectiveness and increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V943000·2018-12-31

    Arcimoto Recalls 2017-2018 FUV Motorcycles for Headlight Spacing Defect

    Arcimoto is recalling 2017-2018 FUV motorcycles because the headlights may be spaced too far apart, making the vehicle difficult to recognize as a motorcycle in the dark.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V941000·2018-12-31

    Arcimoto Recalls 2017-2018 FUV Motorcycles for Turn Signal Placement

    Arcimoto is recalling 2017-2018 FUV motorcycles because front turn signals are not positioned as required by federal safety standards, potentially reducing visibility.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V935000·2018-12-31

    Subaru Recalls 2018 Models for Rearview Camera Software Defect

    Subaru is recalling 2018 Legacy, Outback, and BRZ vehicles because a software issue may prevent the rearview camera from displaying an image while backing up.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY, BRZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V942000·2018-12-31

    Arcimoto Recalls 2017-2018 FUV Motorcycles for Missing Side Reflectors

    Arcimoto is recalling 2017-2018 FUV motorcycles because the rear light assembly lacks required side reflex reflectors, reducing visibility and increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·125-2018·2018-12-30

    Zeigler Red Hot Sausage Recalled for Metal Contamination

    R. L. Zeigler Co. is recalling Red Hot chicken and pork sausage products due to possible metal contamination. No illnesses have been reported.

    Product
    R. L. Zeigler Co. Inc. — R. L. Zeigler Co., Inc. Recalls Chicken and Pork Red Hot Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V934000·2018-12-28

    Hyundai Recalls Sonata and Santa Fe Sport for Fuel Pipe Fire Risk

    Hyundai is recalling 2011-2014 Sonata and 2013-2014 Santa Fe Sport vehicles because a fuel pipe may leak, increasing the risk of a fire.

    Product
    HYUNDAI — HYUNDAI SANTA FE SPORT, SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V933000·2018-12-27

    Forest River Recalls 2019 Salem and Wildwood Trailers for Fire Risk

    Forest River is recalling 2019 Salem and Wildwood recreational trailers because the power cord hatch is located above the water heater exhaust, which may cause melting and increase fire risk.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0733-2019·2018-12-26

    Sprout Creek Farm Raw Cows' Milk Cheese Recalled for Listeria Risk

    Sprout Creek Farm is recalling four wheels of Kinkead raw cows' milk cheese due to potential Listeria monocytogenes contamination.

    Product
    Sprout Creek Farm Kinkead raw cows' milk cheese semi-firm savory brothy. The product is packaged with an orange label.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0775-2019·2018-12-26

    Inspired Organic Sunflower Butter Recalled for Listeria monocytogenes Contamination

    Lipari Foods is recalling Inspired Organic Sunflower Butter because product testing found Listeria monocytogenes. The recall covers 972 cases distributed across 15 states and Canada.

    Product
    Inspired Organic Sunflower Butter 16oz. plastic jar, 6 per case UPC #: 863669742526 refrigerate after opening
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Food)·F-0777-2019·2018-12-26

    Inspired Organic Tahini Butter Recalled for Listeria monocytogenes Contamination

    Lipari Foods is recalling Inspired Organic Tahini Butter because product testing confirmed the presence of Listeria monocytogenes.

    Product
    Inspired Organic Tahini Butter 16oz. plastic jar, 6 per case UPC #: 863669742564 refrigerate after opening
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Food)·F-0728-2019·2018-12-26

    Achdut Recalls Raw Tahini Products Due to Salmonella Contamination Risk

    Achdut is recalling specific lots of raw tahini because the product may be contaminated with Salmonella. The recall affects units distributed to New York, California, Pennsylvania, and Israel.

    Product
    Raw Tahini sold under the following brand names: Baron's raw Tahini, 454g, UPC: 816412010083; Soom raw Tahini 220kg (no barcode on product); Soom raw Tahini 18kg, UPC: 718088347329; Soom raw Tahini, 454g, UPC: 718088347411
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-0360-2019·2018-12-26

    Lubrisine eye drops recalled for undeclared colloidal silver and sterility issues

    Results RNA, LLC is recalling Lubrisine eye drops nationwide due to lack of sterility assurance and the presence of undeclared colloidal silver.

    Product
    Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0776-2019·2018-12-26

    Lipari Foods Recalls Inspired Organic Almond Butter Due to Listeria

    Lipari Foods is recalling Inspired Organic Almond Butter because product testing found Listeria monocytogenes. Consumers should stop using the product.

    Product
    Inspired Organic Almond Butter 16oz. plastic jar, 6 per case UPC #: 863669742540 refrigerate after opening
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Food)·F-0748-2019·2018-12-26

    Bakkavor Baked Macaroni and Cheese Recalled for Undeclared Allergens

    Bakkavor Foods USA Inc. is recalling Baked Macaroni and Cheese because it contains lobster, shrimp, and soy that are not listed on the label.

    Product
    Baked Macaroni and Cheese, NET WT 12 OZ (340g), CONTAINS: WHEAT, MILK, EGG, Produced By BAKKAVOR USA, 2700 Westinghouse Blvd. Charlotte, NC 28273, Phone: 704-522-1977, UPC 7 61088 80502 3
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0729-2019·2018-12-26

    Galil Seasoned Tahini Recalled Due to Salmonella Contamination Risk

    Achdut is recalling Galil Seasoned Tahini because it may be contaminated with Salmonella. The product was distributed in New York, California, Pennsylvania, and Israel.

    Product
    Seasoned Tahini sold under the following brand name: Galil Seasoned Tahini, 500g, UPC: 814968020020
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0726-2019·2018-12-26

    Marich Recalls Milk Chocolate Maltballs Due to Undeclared Macadamia Nuts

    Marich Confectionery is recalling 15 lb cases of Milk Chocolate Maltballs because a customer found undeclared macadamia nuts in the shipment.

    Product
    Milk Chocolate Maltballs: NET Wt. 15 lbs. Item number 992 Case UPC 00797817-00992-9 Allergy Information: This product contains Wheat, milk and soy and may contain peanuts and tree nuts.
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Food)·F-0730-2019·2018-12-26

    Achdut Recalls Tahini Products Due to Potential Salmonella Contamination

    Achdut is recalling specific Baron's and Galil tahini products because they may be contaminated with Salmonella. The products were distributed in New York, California, Pennsylvania, and Israel.

    Product
    Tahini sold under the following brand names: Baron's Tahini double pack, 454g, UPC: X000EZ2HCB; Galil whole tahini, 500g, UPC: 814968020037
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0734-2019·2018-12-26

    Country Favor Recalls Best Taste Dried Bamboo Shoots for Undeclared Sulfites

    Country Favor Inc. is recalling Best Taste Brand Dried Bamboo Shoots because the product contains undeclared sulfites. The recall affects 81 cases distributed across 23 states.

    Product
    Best Taste Brand DRIED BAMBOO SHOOT Mang Non. The product comes in a 12 ounce (340g) uncoded flexible plastic package with UPC: 6 9709 999 40196. Product of P.R.C.
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Drugs)·D-0335-2019·2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of infants' ibuprofen oral suspension because they may contain a higher concentration of the active ingredient.

    Product
    infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0354-2019·2018-12-26

    Enovachem Recalls Dyural-80 Injection Kits Due to Incorrect Latex Labeling

    Enovachem is recalling Dyural-80 Injection Kits because the product insert incorrectly stated that the stoppers do not contain latex, when they actually contain natural rubber latex.

    Product
    Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0778-2019·2018-12-26

    Lipari Foods Recalls Inspired Organic Peanut Butter for Listeria

    Lipari Foods Operating Company, LLC is recalling Inspired Organic Peanut Butter after product testing returned positive results for Listeria monocytogenes.

    Product
    Inspired Organic Peanut Butter 16oz. plastic jar, 6 per case UPC #: 863669742588 refrigerate after opening
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0766-2019·2018-12-26

    Luckyberry Cold-Pressed Juice Recalled for Unpasteurized Juice Violations

    Luckyberry is recalling cold-pressed juice products sold in Lawrence, KS, because they were manufactured and distributed in violation of FDA regulations requiring pasteurization.

    Product
    Luckyberry Cold-Pressed Juice, NoCoast, Kale, Cucumber, Green Apple, Celery, Lemon, Ginger, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0353-2019·2018-12-26

    Dyural-40 Injection Kit Recalled for Incorrect Latex Labeling

    Asclemed USA Inc. is recalling Dyural-40 Injection Kits because the product insert incorrectly states that the stoppers do not contain latex, when they actually do.

    Product
    Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0336-2019·2018-12-26

    Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

    Tris Pharma is recalling 19,488 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0343-2019·2018-12-26

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 85 vials of Human Chorionic Gonadotropin 3000 IU due to inadequate processes to assure sterility.

    Product
    Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0338-2019·2018-12-26

    Gordon Laboratories Recalls Monsel's Solution Due to High Iron Levels

    Gordon Laboratories is recalling specific batches of Monsel's (Ferric Subsulfate) Solution because they contain higher levels of iron than labeled.

    Product
    Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0626-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling specific lots of the Covidien Emprint Short Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft during use, potentially remaining in the patient.

    Product
    Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0627-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Ablation Antenna Due to Tip Disengagement

    FDA is recalling the Covidien Emprint Standard Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0774-2019·2018-12-26

    Luckyberry Recalls Unpasteurized Cold-Pressed Juice for Regulatory Violation

    Luckyberry is recalling unpasteurized Mai Tai and Orange Pineapple cold-pressed juices sold in Lawrence, Kansas, due to violations of FDA juice safety regulations.

    Product
    Luckyberry Cold-Pressed Juice, Mai Tai, Orange Pineapple, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0337-2019·2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of Infants' Ibuprofen because they may contain a higher concentration of the active ingredient.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0771-2019·2018-12-26

    Luckyberry Recalls Unpasteurized Cold-Pressed Juice for Regulatory Violations

    Luckyberry is recalling unpasteurized cold-pressed juice products distributed in Lawrence, Kansas, due to violations of FDA juice safety regulations.

    Product
    Luckyberry Cold-Pressed Juice, Seasonal Blend, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0727-2019·2018-12-26

    Achdut Recalls Organic Tahini Products Due to Salmonella Contamination Risk

    Achdut is recalling multiple brands of organic tahini because the product may be contaminated with Salmonella. The recall affects 88,490 units distributed in New York, California, Pennsylvania, and Israel.

    Product
    Organic Tahini sold under the following brand names: Pepperwood organic tahini, 428g, UPC: 860294001400; Pepperwood whole organic tahini, 428 g, UPC: 860294001417; Baron's organic Tahini, 454g, UPC: 816412011059; Galil, organic Tahini, 500g, UPC: 7290000572086; Soom organic Tahin
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0334-2019·2018-12-26

    Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Bags

    Pharmedium Services, LLC is voluntarily recalling 295 bags of Fentanyl Citrate and Ropivacaine HCl injection because the product was found to be sub-potent.

    Product
    Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0625-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling specific lots of the Covidien Emprint Long Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0333-2019·2018-12-26

    Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Syringes

    Pharmedium Services, LLC is voluntarily recalling 295 syringes of a fentanyl and ropivacaine injection that were found to be sub-potent.

    Product
    Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0770-2019·2018-12-26

    Luckyberry Recalls Unpasteurized Cold-Pressed Spicy Ginger Juice

    Luckyberry is recalling unpasteurized Spicy Ginger cold-pressed juice sold in Lawrence, KS, due to a violation of FDA juice safety regulations.

    Product
    Luckyberry Cold-Pressed Juice, Spicy Ginger, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0615-2019·2018-12-26

    Abbott i-STAT CG8+ Cartridges Recalled for Inaccurate Potassium Results

    Abbott Point Of Care Inc. is recalling i-STAT CG8+ Cartridges because they may generate inaccurate potassium results, potentially leading to incorrect clinical decisions.

    Product
    Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-0769-2019·2018-12-26

    Luckyberry Recalls Unpasteurized Cold-Pressed Juice for Regulatory Violation

    Luckyberry is recalling unpasteurized cold-pressed juice sold in Lawrence, Kansas, due to violations of FDA juice safety regulations.

    Product
    Luckyberry Cold-Pressed Juice, Merc Blend, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0768-2019·2018-12-26

    Luckyberry Cold-Pressed Juice Recalled for Unpasteurized Juice Violation

    Luckyberry is recalling cold-pressed juice products because they were manufactured and distributed in violation of FDA regulations requiring pasteurization or HACCP compliance.

    Product
    Luckyberry Cold-Pressed Juice, Clean & Clear, Pineapple, Green Apple, Cucumber, Min, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0772-2019·2018-12-26

    Luckyberry Cold-Pressed Beetnik Juice Recalled for Unpasteurized Status

    Luckyberry is recalling cold-pressed Beetnik juice sold in Lawrence, KS, because the product was manufactured and distributed in violation of FDA regulations requiring pasteurization.

    Product
    Luckyberry Cold-Pressed Juice, Beetnik, Orange, Red Beet, Kale, Cucumber, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0497-2019·2018-12-26

    COVIDIEN Recalls Puritan Bennett 980 Ventilators Due to Software Update Issues

    COVIDIEN LLC is recalling 9,593 Puritan Bennett 980 ventilators worldwide due to a software update affecting external USB drive performance and GUI functionality.

    Product
    Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient popu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0746-2019·2018-12-26

    ASK Foods Firecracker Slaw Recalled for Listeria and Salmonella Contamination

    ASK Foods Inc. is recalling Firecracker Slaw due to potential contamination with Listeria monocytogenes or Salmonella. The product was sold in bulk containers from delis in multiple states.

    Product
    ASK Foods Inc. Naturally Creative Firecracker Slaw, 3.75 lb. Bulk Container sold from the deli
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0614-2019·2018-12-26

    Philips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors

    Philips is recalling 651 Xper Flex Cardio Physiomonitoring Systems because software defects may cause inaccurate waveform displays, frozen oxygen saturation values, or non-updating blood pressure readings.

    Product
    Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0740-2019·2018-12-26

    Danone Recalls Light & Fit Greek Crunch Yogurt for Peanut Mislabeling

    Danone is recalling Light & Fit Greek Crunch Nonfat Yogurt & Toppings S Mores Flavor because some toppers contain peanuts but are not labeled as such.

    Product
    LIGHT & FIT¿ GREEK CRUNCH NONFAT YOGURT & TOPPINGS S MORES FLAVOR, 5 oz Preformed cups with a topper, Refrigeration required between 36F and 45F, UPC 36632 03825
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-0619-2019·2018-12-26

    ICU Medical Recalls Sapphire Epidural Sets Due to Occlusion Alarms

    ICU Medical is recalling 31,050 units of Sapphire Epidural Sets due to reports of distal occlusion alarms during use.

    Product
    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0659-2019·2018-12-26

    Konica Minolta Recalls 151 X-Ray Systems Due to Unintentional Movement

    Konica Minolta is recalling 151 Advanced Universal U-Arm 4000 X-ray systems because the U-Arm may move unintentionally.

    Product
    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 300 Operating Room Tables

    Deerfield Imaging is recalling 14 IMRIS ORT 300 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0732-2019·2018-12-26

    Oakhouse Bakery Recalls Kwik Trip Granola for Undeclared Tree Nuts

    Oakhouse Bakery is recalling Kwik Trip Bulk Granola because it may contain undeclared cashews and almonds.

    Product
    Kwik Trip Granola, Bulk Granola, 09976. Net Wt 20 lbs / 9.1 kg. Manufactured by: Oakhouse Bakery, 2221 Mustang Way, Madison, WI 53718.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0731-2019·2018-12-26

    Turkey Hill Vanilla Bean Ice Cream Recalled for Unlabeled Soy

    Harris Teeter is recalling Turkey Hill Vanilla Bean Ice Cream because some containers contained Cotton Candy Ice Cream with unlabeled soy lecithin.

    Product
    TURKEY HILL Vanilla Bean Premium Ice Cream #501 3 GAL (11.36L) paper carton CONTAINS: MILK Distributed By: Turkey Hill Dairy 2601 River Rd. Conestoga, PA 17618, call 1-800-MY DAIRY or www.turkeyhill.com, Mfd. at plant #37-087, UPC 0 20735 13520 4
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0649-2019·2018-12-26

    Foundation Medicine Recalls 800 FoundationOne CDx Test Reports

    Foundation Medicine is recalling 800 FoundationOne CDx test reports because an incorrect result for a single analyte may have been reported.

    Product
    FoundationOne CDx Test Results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V932000·2018-12-26

    Spartan Metrostar and Gladiator Fire Apparatus Brake Recall

    Spartan is recalling 2011-2019 Metrostar and Gladiator fire apparatus vehicles due to a brake release delay that may hinder movement and increase crash risk.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2019·2018-12-26

    Jarvik 2000 Ventricular Assist System External Cables Recalled for Connector Damage

    Jarvik Heart Inc is recalling 274 external cable components for the Jarvik 2000 Ventricular Assist System due to potential damage to male connectors.

    Product
    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0657-2019·2018-12-26

    Howmedica Recalls Reliance LITe Nerve Hooks Due to Shape Defects

    Howmedica Osteonics Corp. is recalling 39 units of Reliance LITe Nerve Hooks because the probes have incorrect shapes, including flat surfaces and sharp edges.

    Product
    Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF p
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0617-2019·2018-12-26

    Siemens Dimension Vista 1500 Recalled for Potential Sample Contamination

    Siemens is recalling Dimension Vista 1500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Streptococcus Susceptibility Cards Due to False Results

    bioMerieux is recalling VITEK 2 Streptococcus Susceptibility Cards because they may produce false resistant results for specific Streptococcus strains.

    Product
    VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 100 Tables Due to Roll Drift

    Deerfield Imaging is recalling 27 IMRIS ORT 100 tables because they may drift in the roll position during use, posing a risk of patient injury.

    Product
    IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0639-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Systems Software Version 9.01 Update Kit

    bioMerieux is recalling VITEK 2 Systems Software Version 9.01 Update Kits because they may display incorrect organism identification and antimicrobial susceptibility testing results.

    Product
    VITEK¿ 2 Systems Software Version 9.01 Update Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2019·2018-12-26

    Ortho-Clinical VITROS 5600 Recall for Software Stability Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0747-2019·2018-12-26

    Mariner Seafood Recalls Farmed Coho Salmon for Listeria Contamination

    Mariner Seafood, LLC is recalling specific lots of Farmed Coho Salmon because testing confirmed the presence of Listeria monocytogenes. The product was distributed in California and New Jersey.

    Product
    Salmon packaged in a plastic container; HELLO QUALITY PACIFIC SILVERSIDE SALMON Hello FRESH NET WT. 10oz (283g) with Case Label: keep Frozen (0F or below) FARMED COHO SALMON 10 oz (283g) 2 X 5 oz portions.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0743-2019·2018-12-26

    ASK Foods Recalls Smokey Mozzarella Pasta Salad Due to Contamination Risk

    ASK Foods Inc. is recalling 4 lb. bulk containers of Smokey Mozzarella Pasta Salad due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    ASK Foods Inc. Smokey Mozzarella Pasta Salad, 4 lb. Bulk Container sold from the deli and to food service accounts
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0643-2019·2018-12-26

    Theragenics Brachytherapy Applicator Needles Recalled for Unsealed Pouches

    Theragenics is recalling Brachytherapy Applicator Needles because some pouches were not sealed, potentially compromising sterility.

    Product
    Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0744-2019·2018-12-26

    ASK Foods Rigatoni Casserole Recalled for Listeria and Salmonella Risk

    ASK Foods Inc. is recalling Rigatoni Casserole due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    ASK Foods Inc. Rigatoni Casserole, 5 lb. Aluminum Tray Pan sold on Hot Bar at Retailer
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0652-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System units due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0647-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 200 Tables Due to Roll Drift

    Deerfield Imaging is recalling 14 IMRIS ORT 200 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0741-2019·2018-12-26

    Wegmans Roasted Corn and Bean Salad Recalled for Listeria and Salmonella

    ASK Foods Inc is recalling Wegmans Roasted Corn and Bean Salad due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    Wegmans Roasted Corn and Bean Salad; 13 oz. Plastic Container, 40 oz. Plastic Container, 4.5 lb. Plastic Bulk Container
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0654-2019·2018-12-26

    Bracco Recalls Empower FastLoad CT Syringe Packs Due to Seal Defect

    Bracco is recalling 33,350 Empower FastLoad CT Syringe Packs because an insufficient seal on the sterile barrier may compromise the device's sterility.

    Product
    Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe kit designed for use with EmpowerCT¿, EmpowerCTA¿ an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0739-2019·2018-12-26

    Kwik Trip Strawberry Parfait Recalled for Undeclared Tree Nuts

    Kwik Trip is recalling Kitchen Cravings Strawberry Parfaits because they may contain undeclared almonds and cashews.

    Product
    Kitchen Cravings Strawberry Parfait, Net Wt 8.25 oz (234g) Creamy Parfait Base, Strawberries with Sweetened Granola. Keep Refrigerated. UPC 39779-18433. Produced and Distributed by Kwik Trip, Inc., La Crosse, WI 54603
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0616-2019·2018-12-26

    Siemens Dimension Vista 500 Recalled for Sample Contamination Risk

    Siemens is recalling Dimension Vista 500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS T2X Tables Due to Roll Position Drift

    Deerfield Imaging is recalling 15 IMRIS T2X tables because they may drift in the roll position while in use.

    Product
    IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0745-2019·2018-12-26

    ASK Foods Roasted Corn and Edamame Salad Recalled for Contamination

    ASK Foods Inc. is recalling 278 cases of Roasted Corn and Edamame Salad due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    ASK Foods Inc. Naturally Creative, Roasted Corn and Edamame Salad, 4 lb. Bulk Container sold from the deli
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-0750-2019·2018-12-26

    Moonstruck Chocolate Recalls Salty Nutty Toffee Bar for Undeclared Soy

    Moonstruck Chocolate Company is recalling 323 bars of ALMA Salty Nutty Toffee Bar because the product contains undeclared soy lecithin.

    Product
    The Salty Nutty Toffee Bar, brand ALMA, net weight 1.85 oz. UPC on individual bar: 8 58533 00602 8 UPC on master case 0 108585 330060 2 The label is read in parts: "***INGREDIENTS: Salty Nutty Toffee Bar *** Dark Chocolate (cocoa solids, cocoa butter, sugar, sunflower lec
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0738-2019·2018-12-26

    Kwik Trip Mixed Berry Parfait Recalled for Undeclared Tree Nuts

    Kwik Trip is recalling Kitchen Cravings Mixed Berry Parfaits because they may contain undeclared almond and cashew.

    Product
    Kitchen Cravings Mixed Berry Parfait, Net Wt 8.25 oz (234g) Creamy Parfait Base, Strawberries & Blueberries with Sweetened Granola. Keep Refrigerated. UPC 39779-18436. Produced and Distributed by Kwik Trip, Inc., La Crosse, WI 54603
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0609-2019·2018-12-26

    Mazor Robotics Recalls Carousel Accessories for Brain and Spinal Surgery Kits

    Mazor Robotics is recalling five Carousel MAS1025-01 units used in brain and spinal surgery kits because the position pin may fail, causing the carousel to move inadvertently.

    Product
    Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended t
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0742-2019·2018-12-26

    ASK Foods Recalls Rotini Salad Due to Listeria and Salmonella Risk

    ASK Foods Inc is recalling Taste of Inspirations Rotini Salad due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    Taste of Inspirations Rotini Salad, Net Wt. 13 oz., Pre-pack Container sold to consumer by retailer, 4 lb. Bulk Container sold from the deli
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0658-2019·2018-12-26

    Fresenius Optiflux F160NR Dialyzers Recalled for Potential Blood Leaks

    Fresenius Medical Care is recalling Optiflux F160NR dialyzers due to a potential for external blood leaks from the dialyzer header.

    Product
    Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2019·2018-12-26

    Diagnostica Stago Recalls Staclot LA 20 Test Kits Due to Result Variability

    Diagnostica Stago is recalling Staclot LA 20 test kits because some results showed shortened times outside the expected range.

    Product
    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0628-2019·2018-12-26

    Bausch & Lomb Recalls enVista Intraocular Lenses Due to Surface Imperfections

    Bausch & Lomb is recalling 70,440 enVista intraocular lenses due to cosmetic surface imperfections. The lenses are distributed nationwide.

    Product
    enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0623-2019·2018-12-26

    Clark Laboratories Recalls Genesys 2 Reagent Due to Lack of 510(k) Clearance

    Clark Laboratories is recalling 216 units of Genesys 2 Reagent because the product lacks the required FDA 510(k) clearance for marketing.

    Product
    Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0622-2019·2018-12-26

    Clark Laboratories Recalls Genesys 1 Reagent for Lack of 510(k) Clearance

    Clark Laboratories is recalling 252 units of Genesys 1 Reagent because the product lacks FDA 510(k) clearance. The recall is voluntary and has been terminated.

    Product
    Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0633-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging lists incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0621-2019·2018-12-26

    Clark Laboratories Recalls Genesys Analytical Columns Due to Missing 510(k) Clearance

    Clark Laboratories, Inc. is voluntarily recalling 372 Genesys Analytical Columns because they were distributed without FDA 510(k) clearance.

    Product
    Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0382-2019·2018-12-26

    Cipla Recalls Nevirapine Extended Release Tablets for Dissolution Failure

    Cipla Limited is recalling 4,800 bottles of Nevirapine Extended Release Tablets, 400 mg, because they failed to meet dissolution specifications.

    Product
    Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0340-2019·2018-12-26

    KVK-Tech Recalls Oxybutynin Chloride Tablets Due to Wrong Bar Code

    KVK-Tech, Inc. is recalling 156 bottles of Oxybutynin Chloride Tablets, 5 mg, because they bear the wrong bar code.

    Product
    OXYBUTYNIN CHLORIDE — OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0630-2019·2018-12-26

    Zimmer Biomet Recalls NexGen Knee Augment Blocks Due to Missing Screws

    Zimmer Biomet is recalling 19 NexGen Complete Knee Solution Femoral Augment Blocks because a screw is missing from the package.

    Product
    NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2019·2018-12-26

    Tosoh AIA-360 Analyzer Recalled for Table Home Sensor Malfunction

    Tosoh Bioscience Inc is recalling 438 AIA-360 Analyzers because a table home sensor malfunction can cause the device to stop functioning, potentially delaying patient test results.

    Product
    AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immuno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0638-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0319-2019·2018-12-26

    GE Healthcare Recalls Omnipaque Injection Due to Vial Defect

    GE Healthcare is recalling 1,092 cartons of Omnipaque (iohexol) Injection in Tennessee due to a vial defect that could compromise sterility or introduce glass particles.

    Product
    OMNIPAQUE — OMNIPAQUE (IOHEXOL)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0640-2019·2018-12-26

    Advanced Instruments Recalls GloCyte RBC Reagent Due to QC Failure

    Advanced Instruments, LLC is recalling GloCyte RBC Reagent because high fluorescent counts cause quality control checks to fail, preventing patient sample testing.

    Product
    GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0610-2019·2018-12-26

    Diagnostica Stago Recalls Staclot LA Test Kits Due to Result Variability

    Diagnostica Stago is recalling Staclot LA test kits because some results showed shortened times, potentially affecting lupus anticoagulant detection accuracy.

    Product
    Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
    Category
    Medical Device
    Distribution
    Distributed nationwide

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