The Recall Desk

Archive

July 2017 recalls

930 recalls were announced in July 2017.

What the numbers show

Critical
40
Severe
116
High
613
Moderate
135
Low
26

Of the 930 recalls this month scored against our rubric, 4% are Critical, 12% are Severe.

501–600 of 930

  • SevereNHTSA·17V468000·2017-07-22

    Piaggio Recalls 2014-2017 Fly 150 3V Scooters for Brake Defect

    Piaggio is recalling 2014-2017 Fly 150 3V scooters because front brake disc mounting screws may loosen, potentially causing the front wheel to lock up and increasing crash risk.

    Product
    PIAGGIO — PIAGGIO FLY 150 3V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V467000·2017-07-21

    BMW Recalls 2017 C Evolution and C650 GT Scooters for Rim Marking Defect

    BMW is recalling 2017 C Evolution and C650 GT scooters because front rims may lack required markings, which could lead to incorrect tire installation and handling issues.

    Product
    BMW — BMW C EVOLUTION, C650 GT MAXI-SCOOTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·083-2017·2017-07-20

    Cesina Sausage Company Recalls Pork Kolbassi Due To Misbranding

    Cesina Sausage Company is recalling 10 pounds of pork kolbassi labeled as ready-to-eat but actually not ready-to-eat. No illnesses have been reported.

    Product
    Cesina Sausage Co. — Cesina Sausage Company Recalls Pork Product Due To Misbranding
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·17V464000·2017-07-20

    Tremcar Recalls Rear Impact Guards on Certain Trailers

    Tremcar is recalling rear impact guards on specific trailers because they may not adequately resist force in a crash, increasing the risk of injury.

    Product
    TREMCAR — TREMCAR 1625FT3 VAC TANDEM, 2800FT3 DRY BULK QUAD, 1350FT3 B-TRAIN PUP, 2300FT3 QUAD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V460000·2017-07-20

    Spartan Motors Recalls 2015-2017 Aeromaster Vehicles for Wiper Motor Defect

    Spartan Motors is recalling 2015-2017 Utilimaster Aeromaster vehicles because a missing ground wire may cause intermittent loss of windshield wiper function, increasing crash risk.

    Product
    UTILIMASTER — UTILIMASTER AEROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0962-2017·2017-07-19

    FDA Recalls Cummor Male Enhancement Supplement for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling Cummor Natural Male Enhancement capsules because FDA analysis found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV --- UPC code #680474229116
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0968-2017·2017-07-19

    FDA Recalls BIGnHARD Male Enhancement Capsules for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling BIGnHARD Male Enhancement Capsules because FDA testing found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0971-2017·2017-07-19

    LabidaMAX Herbal Supplement Recalled for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling LabidaMAX Herbal Dietary Supplement Capsules because FDA analysis found undeclared prescription drugs.

    Product
    LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228904
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0964-2017·2017-07-19

    Xrect Male Enhancement Supplement Recalled for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling Xrect Male Enhancement capsules because FDA analysis found undeclared prescription drugs tadalafil, sildenafil, and Flibanserin.

    Product
    Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA ---- UPC Code 680474015795
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2577-2017·2017-07-19

    Kroger Simple Truth Macadamia Nuts Recalled for Listeria

    Kroger is recalling Simple Truth Dry Roasted Macadamia Nuts due to an expanded supplier notification regarding Listeria monocytogenes.

    Product
    Simple truth Dry Roasted Macadamia Nuts 12 oz bags UPC 0 1111 00247 8 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Drugs)·D-0965-2017·2017-07-19

    Rectalis Male Enhancement Supplement Recalled for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling Rectalis Male Enhancement Capsules because FDA analysis found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228782
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0966-2017·2017-07-19

    Tornado Male Enhancement Supplement Recalled for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling Tornado Male Enhancement capsules because FDA analysis found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0963-2017·2017-07-19

    ZRECT Male Enhancement Supplement Recalled for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling ZRECT Male Enhancement capsules because FDA analysis found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999451
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2541-2017·2017-07-19

    Wildway Coconut Cashew Granola Recalled for Listeria Risk

    Wildway LLC is recalling specific lots of Coconut Cashew Grain-free Granola due to potential contamination with Listeria monocytogenes.

    Product
    Wildway Coconut Cashew Grain-free Granola 8 oz. and 10 oz. UPC: 858660005183 packaged in a plastic bag
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0967-2017·2017-07-19

    FDA Recalls ZDaily Testosterone Supplement for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling ZDaily Testosterone and Libido Booster capsules because FDA analysis found undeclared prescription drugs, including tadalafil, sildenafil, and flibanserin.

    Product
    ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229062
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2398-2017·2017-07-19

    Pacific Wave Yellow Fin Tuna Loins Recalled for Hepatitis A

    P & E Foods Inc is recalling Pacific Wave Yellow Fin Tuna loins after testing revealed a positive result for Hepatitis A.

    Product
    Pacific Wave Yellow Fin Tuna loins; 30 lb. cases. Product of Indonesia; Imported by Unified Seafood Co., Inc.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0961-2017·2017-07-19

    UPROAR Male Enhancement Supplement Recalled for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling UPROAR male enhancement capsules because FDA testing found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4 and 10 count packages, Distributed by AH Distribution, DelRay, Beach, FL ---- UPC Code 680474229260
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0970-2017·2017-07-19

    FDA Recalls ZRECT for Women Herbal Supplement Due to Undeclared Drugs

    Organic Herbal Supply is recalling ZRECT for Women herbal capsules because FDA testing found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229055
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2534-2017·2017-07-19

    Smokehouse of NY Recalls Smoked Norwegian Fish for Listeria Risk

    The Smokehouse of New York is recalling smoked Norwegian fish due to potential Listeria monocytogenes contamination. The product was distributed in six states.

    Product
    The Smokehouse of NY Smoked Norwegian Fish packaged as: 4oz & 8oz and whole sides
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-2426-2017·2017-07-19

    Ardent Mills Recalls Primo Molino Flour Due to E. coli O121 Contamination

    Ardent Mills, LLC is recalling 487 bags of Primo Molino Italian Style Enriched Flour because it may be contaminated with E. coli O121.

    Product
    PRIMO MOLINO ITALIAN STYLE ENRICHED FLOUR, 50 lb, Packaged in paper bags, Store at Ambient Temperature, produced on 10/31/16, Product code 15031
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0969-2017·2017-07-19

    Enhancerol Herbal Supplement Recalled for Undeclared Prescription Drug Ingredients

    Organic Herbal Supply is recalling Enhancerol Herbal Dietary Supplement Capsules because FDA analysis found undeclared tadalafil, sildenafil, and Flibanserin.

    Product
    ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0959-2017·2017-07-19

    Bristol-Myers Squibb Recalls Eliquis 5mg Tablets Due to Labeling Error

    Bristol-Myers Squibb is recalling 48,180 bottles of Eliquis 5mg tablets because one bottle was found to contain 2.5mg tablets instead.

    Product
    EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0976-2017·2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 221 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0957-2017·2017-07-19

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 0.9% Sodium Chloride Injection bags due to customer complaints about leaking bags, which raises concerns about the product's sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0956-2017·2017-07-19

    Advanced Pharma Recalls Potassium Phosphate Injection Due to Sterility Concerns

    Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate Injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2536-2017·2017-07-19

    Samiira's Homemade Muhammara Dip Recalled for Undeclared Soy

    Samiira's Homemade Muhammara Roasted Red Pepper Dip is being recalled because it may contain undeclared soy. Consumers should stop using the product.

    Product
    SAMIRA'S HOMEMADE Muhammara Roasted Red Pepper Dip with Walnuts & Pomegranate Molasses, All Natural, NET WT. 8 OZ (229G) Keep Refrigerated
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0978-2017·2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 20 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The affected product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0977-2017·2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 660 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0955-2017·2017-07-19

    Advanced Pharma Recalls Potassium Phosphate Bags Due to Sterility Concerns

    Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride bags because the company cannot assure the product's sterility.

    Product
    Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2576-2017·2017-07-19

    Wildway LLC Recalls Trader Joe's Grainless Granola Due to Listeria Risk

    Wildway LLC is recalling specific lots of Trader Joe's Grainless Granola due to potential contamination with Listeria monocytogenes.

    Product
    Trader Joe's Grainless Granola 8 oz. (SKU 56307) packaged in a plastic bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0953-2017·2017-07-19

    Advanced Pharma Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    Advanced Pharma Inc. is recalling QUELICIN (Succinylcholine Chloride) Injection due to a lack of assurance of sterility. The recall affects 2,350 units distributed nationwide.

    Product
    QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0975-2017·2017-07-19

    CVS Health Baby Eczema Moisturizing Cream Recalled for Microbial Contamination

    Sigan Industries is recalling CVS Health Baby Eczema Moisturizing Cream due to microbial contamination. The product failed to meet total plate count specifications.

    Product
    CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2540-2017·2017-07-19

    Wildway Banana Nut Granola Recalled for Listeria Contamination Risk

    Wildway LLC is recalling 434 cases of Banana Nut Grain-free Granola due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Wildway Banana Nut Grain-free Granola 8 oz. UPC: 858660005176 packaged in a plastic bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0979-2017·2017-07-19

    SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 20 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The affected product was distributed in LA, PA, NY, and WI.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·17V450000·2017-07-19

    Daimler Trucks Recalls 2017-2018 Freightliner and Western Star Trucks for Fuel Pump Defect

    Daimler Trucks is recalling specific 2017-2018 Freightliner and Western Star trucks because a fuel pump drive gear may slip, causing sudden engine stalls and increasing crash risk.

    Product
    FREIGHTLINER CUSTOM CHASS — FREIGHTLINER CUSTOM CHASS, FREIGHTLINER, WESTERN STAR XCP, 122SD, 6900, XCM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0960-2017·2017-07-19

    Teva Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failure

    Teva Pharmaceuticals is recalling 360 bottles of Paliperidone Extended-Release Tablets because one tablet failed a routine stability test for drug release.

    Product
    Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2542-2017·2017-07-19

    Wildway Vanilla Bean Espresso Granola Recalled for Listeria Risk

    Wildway LLC is recalling 442 cases of Vanilla Bean Espresso Grain-free Granola due to potential Listeria monocytogenes contamination.

    Product
    Wildway Vanilla Bean Espresso Grain-free Granola 8 oz. UPC: 858660005206 packaged in a plastic bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0954-2017·2017-07-19

    Advanced Pharma Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 72 units of Potassium Phosphate IV bags nationwide due to a lack of assurance of sterility.

    Product
    Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0972-2017·2017-07-19

    Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 54,528 bags of 5% Dextrose Injection because the bags may leak, compromising sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2712-2017·2017-07-19

    Toshiba APLIO i-series Ultrasound Systems Recalled for Incorrect Velocity Readings

    Toshiba is recalling 28 APLIO i-series diagnostic ultrasound systems because they may display incorrect velocity values when using the Continuous Trace method.

    Product
    APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2721-2017·2017-07-19

    ICU Medical Recalls MicroClave Extension Sets Due to Leak Risk

    ICU Medical is recalling 100 units of MicroClave extension set kits because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (wh
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2700-2017·2017-07-19

    CareFusion Recalls Alaris Pump Module 8100 Due to Latch Design Risk

    CareFusion 303, Inc. is recalling 35,940 Alaris Pump Module model 8100 units in the US and Canada due to a potential risk of unintended flow caused by the sear door latch design.

    Product
    Alaris Pump Module model 8100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2588-2017·2017-07-19

    NatureBox Mini Crispy Snickerdoodles Recalled for Cashew Fragment

    NatureBox is recalling Mini Crispy Snickerdoodles because a cashew fragment was found during packing, posing a potential allergen risk.

    Product
    NatureBox Mini Crispy Snickerdoodles: Cinnamon-sugar cookies made with whole wheat. Contains: Wheat, Milk and Egg.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2716-2017·2017-07-19

    ICU Medical Recalls 18 cm Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 304 units of 18 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may leak.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular sys
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2718-2017·2017-07-19

    ICU Medical Recalls 28 cm Bifuse Extension Sets Due to Leak Risk

    ICU Medical is recalling 50 units of 28 cm Bifuse Extension Sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular syst
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2696-2017·2017-07-19

    St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators

    St. Jude Medical is recalling 40 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices during medical procedures may cause a loss of neuromodulation therapy.

    Product
    Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic cir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2732-2017·2017-07-19

    Nova Biomedical Stat Profile Prime Analyzer Software Recall

    Nova Biomedical is recalling Stat Profile Prime Analyzers because a software defect could cause scheduled quality control tests to overwrite pending patient results.

    Product
    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2676-2017·2017-07-19

    ICU Recalls Plum A+ Infusion Systems Due to Battery-Related Therapy Interruption

    ICU is recalling 10,609 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting patient therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2017·2017-07-19

    Oscor ATAR Reusable Extension Cables Recalled for Connector Separation Risk

    Oscor, Inc. is recalling ATAR Reusable Extension Cables because they may separate from the connector during use, posing a risk to patients.

    Product
    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Food)·F-2572-2017·2017-07-19

    Schooner Pre-Cooked Crunchy Whiting Fillets Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Schooner Pre-Cooked Crunchy Whiting Fillets because the product may contain undeclared milk.

    Product
    SCHOONER PRE-COOKED CRUNCHY WHITING FILLETS 1/10 LB and SCHOONER PRE-COOKED CRUNCHY WHITING FILLETS 12/16 OZ
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-2473-2017·2017-07-19

    Meduri Farms Recalls Dried Strawberries Due to Peanut Fragment

    Meduri Farms Inc is recalling specific lots of Dried Strawberries/Sugar Infused because a half peanut was found on the packaging line.

    Product
    Meduri Farms Dried Strawberries/Sugar Infused, Catalog # 010282. Dried Strawberries sugar infused packaged in a 10, 20 or 25 lbs. corrugated box or 10kg corrugated box with food grade plastic liner. The label is read in parts: "***INGREDIENTS: Strawberries, Sugar, Ascorbic
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2682-2017·2017-07-19

    ICU Recalls Plum A+ Infusion Systems Due to Battery Error

    ICU is recalling 7,351 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2550-2017·2017-07-19

    Matlaws Pre-Cooked Fish Sticks Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Matlaws All Natural Panko Pre-Cooked Fish Sticks because the product may contain undeclared milk.

    Product
    MATLAWS ALL NATURAL PANKO PRE COOKED FISH STICKS 1/10 LB and 10/2 LB
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-2556-2017·2017-07-19

    Murrys Pre-Cooked Steaks Recalled for Undeclared Milk Allergen

    National Fish & Seafood, Inc. is recalling specific lots of Murrys Pre-Cooked Steaks because the product may contain undeclared milk.

    Product
    MURRYS PRE COOKED STEAKS 6/2.4 3.2 OZ, 9/4 3.2 OZ
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-2544-2017·2017-07-19

    Falcon Baie Precooked Fish Portions Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Falcon Baie brand precooked fish portions because they may contain undeclared milk.

    Product
    FALCON BAIE BRAND PRECOOKED FISH PORTIONS MADE FROM MINCED FISH NET WT. 10 LB (4.54 Kg) 3 OZ 4/2.5 LB
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2675-2017·2017-07-19

    ICU Recalls 180 Plum A+ Infusion Systems Due to Battery Issues

    ICU is recalling 180 Plum A+ Infusion Systems because battery issues may cause an E321 error code and interrupt therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2458-2017·2017-07-19

    LJA Enterprises Recalls Nutman Hunter Trail Mix for Undeclared Milk Allergen

    LJA Enterprises is recalling 15 bags of Nutman Hunter Trail Mix because the product failed to declare milk as an ingredient.

    Product
    NUTMAN HUNTER TRAIL MIX 2.5 oz (70 g) bag Ing: Almonds, Blanched Peanuts, Cashews, Salt, Raisins, Choco Buttons, Banana Chips Nuts Processes in Peanut Oil 1-330-833-6660 Massillon, Ohio 44647 UPC
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2460-2017·2017-07-19

    LJA Enterprises Recalls Sweet and Spicy Mix for Undeclared Allergens

    LJA Enterprises is recalling Sweet and Spicy Mix bags in Ohio due to undeclared milk, soy, and wheat allergens.

    Product
    Sweet and Spicy Mix 2 oz & 3 oz bags Cashews, Craisins, Honey Roasted Peanuts, Pepper Nuts, Honey Sesame Sticks MANUFACTURED IN A FIRM THAT ALSO PROCESSES PEANUTS Massillon, Ohio 44647
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2456-2017·2017-07-19

    Publix Tropical Fruit Medley Recalled for Possible Listeria Presence

    Publix is recalling Tropical Fruit Medley due to the possible presence of Listeria monocytogenes. Consumers should discard the product.

    Product
    Publix Tropical Fruit Medley, NET WT. 5.7 OZ (161.6g), Packaged and Distributed by Publix Super Markets, Inc., Lakeland, FL 33802
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2733-2017·2017-07-19

    Oscor ATAR Disposable Extension Cables Recalled for Connector Separation Risk

    Oscor, Inc. is recalling ATAR Disposable Extension Cables because they may separate from the connector during use, posing a risk to patients.

    Product
    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, AT
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-2678-2017·2017-07-19

    ICU Recalls 214 Plum A+ Infusion Systems Due to Battery Error

    ICU is recalling 214 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V459000·2017-07-19

    Carry-On Trailer Recalls 2017 Models Due to Electric Brake Defect

    Carry-On Trailer is recalling 2017 Utility, Dump, and Enclosed trailers because a faulty breakaway box light may cause the circuit board to fail, increasing crash risk.

    Product
    CARRY-ON TRAILER — CARRY-ON TRAILER ENCLOSED, UTILITY, DUMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2457-2017·2017-07-19

    Nutman Chocolate Peanuts Recalled for Undeclared Soy Allergen

    LJA Enterprises is recalling Nutman Chocolate Peanuts because the product failed to declare soy as an allergen. The product was distributed in Ohio.

    Product
    NUTMAN CHOCOLATE PEANUTS 5 oz (140 g) bags Ing: Peanuts, Sugar, Whole Milk, Liqueur, Coca Butter, Partially Hydrogenated Cocoa Powder, Choc, Salt, Lecithin (emulsifier) Vanilla (art flav..) MANUFACTURED IN A FIRM THAT ALSO PROCESSES PEANUTS Massillon, Ohio 44547 1-330-833-6660 UP
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2537-2017·2017-07-19

    Morris J. Golombeck Recalls Birds Eye Chilies for Potential Peanut Contamination

    Morris J. Golombeck, Inc. is recalling 8,000 lbs of Birds Eye Chilies due to potential peanut contamination. The product was distributed across multiple US states and Canada.

    Product
    BIRDS EYE CHILIES MJG # 8178, Polybags Net wt. 25 Kg (50-55 Lbs.) Imported from Madagascar
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2570-2017·2017-07-19

    Schooner Pre-Cooked Cod Fillets Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Schooner Pre-Cooked Crunchy Styled Cod Fillets because the product may contain undeclared milk.

    Product
    SCHOONER PRE-COOKED CRUNCHY STYLED COD FILLET 10 LB and SCHOONER PRE-COOKED CRUNCHY STYLED COD FILLETS 12/16 OZ
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2707-2017·2017-07-19

    Merge Healthcare Recalls Schiller PB 1000 Patient Data Module

    Merge Healthcare is recalling 555 Schiller PB 1000 Patient Data Modules because the analog output may not accurately reflect the pressure waveform used for fractional flow reserve calculations.

    Product
    The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2683-2017·2017-07-19

    ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption

    ICU is recalling 363,892 Plum A+ Infusion Systems because battery issues can cause an E321 error code, potentially interrupting patient therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2695-2017·2017-07-19

    St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators

    St. Jude Medical is recalling 373 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices may cause a loss of neuromodulation therapy.

    Product
    Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic cir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2692-2017·2017-07-19

    St. Jude Medical Recalls Proclaim 7 Elite Implantable Pulse Generators

    St. Jude Medical is recalling 9,529 Proclaim 7 Elite implantable pulse generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a he
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2574-2017·2017-07-19

    Recall of 365 Everyday Value Precooked Breaded Fish Squares for Undeclared Milk

    National Fish & Seafood, Inc. is recalling 365 Everyday Value Precooked Breaded Fish Squares because the product may contain undeclared milk.

    Product
    365 EVERYDAY VALUE ALL NATURAL PRECOOKED BREADED FISH SQUARES 10/2 LBS NET WT. 20 LBS (9.07 kg)
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2723-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 1,100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the a
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2717-2017·2017-07-19

    ICU Medical Recalls Smallbore Extension Sets Due to Potential Leak

    ICU Medical is recalling 120 units of smallbore extension sets because the connection between the Female Luer and NanoClave manifold may develop a leak.

    Product
    168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container t
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2705-2017·2017-07-19

    O-Two Adult Ventilation Timer Recalled Due to Flash Rate Malfunction

    O-Two Medical Technologies is recalling Adult Ventilation Timers because the flash rate may be twice the labeled rate, potentially affecting ventilation guidance.

    Product
    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2470-2017·2017-07-19

    Greencore USA Recalls Tuna Salad Sandwiches Due to Undeclared Milk Allergen

    Greencore USA is recalling specific Tuna Salad Sandwiches because they contain undeclared milk, a major food allergen.

    Product
    Tuna Salad Sandwich under the following labels: Enzas Choice Tuna Salad on Wheat Bread, 6.6 0z UPC 73508757486 Hannaford Tuna Salad on Club Roll, 5.1 0z UPC 41268165889
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2543-2017·2017-07-19

    Americas Choice Beer Battered Shrimp Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Americas Choice Beer Battered Shrimp because the product may contain undeclared milk.

    Product
    AMERICAS CHOICE B/D SHRIMP BEER BATTERED POPCORN 12/14 OZ
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2694-2017·2017-07-19

    St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators

    St. Jude Medical is recalling 54 Infinity 5 Implantable Pulse Generators due to a risk of therapy loss if exposed to monopolar electrosurgical devices.

    Product
    Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic cir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2471-2017·2017-07-19

    GreenCore USA Recalls Ham Salad Sandwiches for Undeclared Milk Allergen

    GreenCore USA is recalling 17,123 ham salad sandwiches sold in Maine, New York, and Pennsylvania because they contain undeclared milk.

    Product
    Ham Salad Sandwich under the following labels: Enza's Choice Ham Salad on Wheat Bread, 6.6 oz. UPC 73508758165. Hannaford Ham Salad on Club Roll, 5.1 oz . UPC 41268165896. Turkey Hill Fresh Selects Ham Salad on homestyle bread, 4.9 oz. UPC 7350875003
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2466-2017·2017-07-19

    3CS Organics Recalls Unapproved Holle Goat Milk Infant Formula

    3CS Organics LLC is recalling Holle goat milk infant formula products that are not FDA approved and lack English labeling.

    Product
    HOLLE Bio Lait Pour Nourrissons Au Lait De Chevre, Zuigelingenmelk OP Geitenmelbasis, 1, 400g (4/case), HOLLE Bio-Flogemilch Auf Ziegenmilchbasis, 1, 400g (4/case), HOLLE Bio-Folgenmilch Auf Ziegenmilchbasis, 3, 400g (4/case), HOLLE Bio-Folgemich, 2, 600g (3bx/case), HOLLE Bio-Fo
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2697-2017·2017-07-19

    Elekta Leksell Gamma Knife Icon Recall for Electrical Safety Risk

    Elekta is recalling two Leksell Gamma Knife Icon units due to a potential electrical safety risk for technicians performing maintenance.

    Product
    Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2698-2017·2017-07-19

    Arrow Recalls EVOLUTION Pressure Injectable PICC Catheters Due to Hub Tab Detachment

    Arrow International is recalling EVOLUTION Pressure Injectable PICC catheters because the peel-away component hub tabs may prematurely detach during use.

    Product
    Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
    Category
    Medical Device
    Distribution
    11 states

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