The Recall Desk

Archive

March 2019 recalls

999 recalls were announced in March 2019.

What the numbers show

Critical
265
Severe
394
High
255
Moderate
69
Low
16

Of the 999 recalls this month scored against our rubric, 27% are Critical, 39% are Severe.

1–100 of 999

  • SevereUSDA FSIS·039-2019·2019-03-30

    Market of Choice Recalls Pork and Poultry Pâté for Undeclared Allergens

    Market of Choice is recalling pork and poultry pâté products containing undeclared milk and soy allergens. No adverse reactions have been reported.

    Product
    Market of Choice, Inc. Recalls Pork and Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V258000·2019-03-29

    Forest River Recalls 2017-2019 Rockport Work Trucks for Fire Risk

    Forest River is recalling 2017-2019 Rockport work trucks because a missing inline fuse may allow excess current to melt wiring, increasing the risk of a fire.

    Product
    FOREST RIVER — FOREST RIVER ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V259000·2019-03-29

    Supreme Service Body Vehicles Recalled for Missing Head Impact Padding

    Supreme Corporation is recalling 2014-2018 Service Body vehicles on Ford Transit chassis because they may lack required padded trim for head impact protection.

    Product
    SUPREME — SUPREME SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V252000·2019-03-28

    Ford Transit Vans Recalled Over Faulty Foldaway Seats

    Waldoch Crafts is recalling 2018 Ford Transit shuttle vans with Freedman GO-ES foldaway seats. The seat cushion may fail to lock in a crash, posing an injury risk.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V253000·2019-03-28

    Genie Recalls 2019 TZ-34 and TZ-50 Aerial Devices for Fire Risk

    Genie is recalling 2019 TZ-34 and TZ-50 trailer-mounted aerial devices because improperly crimped battery cables may overheat and cause a fire.

    Product
    GENIE — GENIE TZ-34, TZ-50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V248000·2019-03-28

    2019 Jeep Cherokee Recalled for Loose Front Passenger Seat Bolts

    Chrysler is recalling 2019 Jeep Cherokee vehicles because loose front passenger seat mounting bolts may allow the seat to move in a crash, increasing injury risk.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V249000·2019-03-28

    Royale Recalls 2015-2017 Mercedes Sprinter Coaches Due to Seat Lock Defect

    Royale is recalling 2015-2017 Mercedes Sprinter-based mini coaches because the rear seat cushion may not stay locked in place during a crash or sudden stop.

    Product
    MERCEDES ROYALE — MERCEDES ROYALE SPRINTER COACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V250000·2019-03-28

    Road Rescue Ultramedic Recalled for Backup Camera Display Defect

    REV Ambulance Group is recalling 2018-2019 Road Rescue Ultramedic vehicles because backup camera displays may revert to factory settings, causing the image to reverse.

    Product
    ROAD RESCUE — ROAD RESCUE ULTRAMEDIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V251000·2019-03-28

    Fire Equipment Sales Recalls Two Emergency Vehicles With Faulty Brake Lights

    Fire Equipment Sales & Service is recalling two 2018 emergency vehicles because their brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    FORD — FORD, FREIGHTLINER F-550, M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19094·2019-03-28

    Interline Brands Recalls ProPlus Brass Swivel Fittings Due to Fire Hazard

    Interline Brands is recalling ProPlus Brass Flare Swivel Fittings because they can leak, posing a fire hazard. Consumers should contact Interline for a full refund or replacement.

    Product
    ProPlus Brass Flare Swivel Fittings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19092·2019-03-28

    Midwest-CBK Recalls Baby Rattle Socks Due to Choking Hazard

    Midwest-CBK is recalling Baby Rattle Socks because small ornaments can detach, posing a choking hazard to young children. No injuries have been reported.

    Product
    Baby Rattle Socks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V256000·2019-03-28

    Acura Recalls MDX Models Due to Tailgate Light Moisture Ingress

    Honda is recalling 2014-2019 Acura MDX and 2017-2019 MDX Sport Hybrid vehicles because moisture may enter the tailgate lid lights, causing them to fail and reducing vehicle visibility.

    Product
    ACURA — ACURA MDX SPORT HYBRID, MDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1034-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 975 units of Phenylephrine HCl injectable solution due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1028-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine HCl Injectable Syringes for Sterility Concerns

    Advanced Pharma Inc. is recalling 800 syringes of Phenylephrine HCl Injectable Solution due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1048-2019·2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 25 mg, because an impurity was detected. The recall involves 456,732 bottles distributed by Wal-Mart.

    Product
    Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1020-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine HCl Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 16,075 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1054-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 160 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.

    Product
    Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1031-2019·2019-03-27

    Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,440 syringes of Heparin 5,000 Units/5mL Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1027-2019·2019-03-27

    Advanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,980 syringes of 2% Lidocaine HCl Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1018-2019·2019-03-27

    Advanced Pharma Recalls Fentanyl Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 180 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1051-2019·2019-03-27

    Preferred Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Preferred Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1029-2019·2019-03-27

    Advanced Pharma Recalls Esmolol HCl Injectable Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 550 syringes of Esmolol HCl Injectable Solution due to a lack of assurance of sterility. The affected products were distributed nationwide.

    Product
    Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1025-2019·2019-03-27

    Advanced Pharma Recalls Glycopyrrolate Injectable Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 140 syringes of Glycopyrrolate 0.6 mg/3 mL Injectable Solution because the company cannot ensure the product is sterile.

    Product
    Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1022-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,575 syringes of Phenylephrine HCl injectable solution because the company cannot guarantee the product is sterile.

    Product
    Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1047-2019·2019-03-27

    Valsartan Tablets Recalled Due to Carcinogenic Impurity

    American Health Packaging is recalling Valsartan Tablets 160 mg because a carcinogenic impurity was detected in the active ingredient.

    Product
    Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1052-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 40 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.

    Product
    Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1036-2019·2019-03-27

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1032-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,850 syringes of Phenylephrine HCl Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1172-2019·2019-03-27

    Dahlicious Organic Lassi Recalled for Improper Pasteurization

    Dahlicious is recalling 2,175 bottles of Organic Lassi India-Style Drinkable Yogurt because the product was improperly pasteurized.

    Product
    DAHlicious ORGANIC Lassi India -Style DRINKABLE YOGURT, Grassland Plain, , 32 FL OZ (946 mL), UPC: 7 93573 01459 7
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1026-2019·2019-03-27

    Advanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,540 syringes of 2% Lidocaine HCl Injectable Solution because the company cannot assure the product's sterility.

    Product
    2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1050-2019·2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Detection

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 100 mg, due to the presence of the impurity N-Methylnitrosobutyric acid (NMBA).

    Product
    Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-579-54
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1038-2019·2019-03-27

    Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA is recalling specific lots of Valsartan 80 mg tablets because FDA analysis confirmed trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1030-2019·2019-03-27

    Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 500 syringes of Heparin 10 Units/10 mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1030-2019·2019-03-27

    CTL Medical Hex Driver Recalled Due to Anti-Toggle Ring Separation Risk

    CTL Medical is recalling 133 Hex Drivers because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.

    Product
    CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1037-2019·2019-03-27

    Aurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1045-2019·2019-03-27

    AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1016-2019·2019-03-27

    Advanced Pharma Recalls Hydromorphone Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 2,400 syringes of Hydromorphone HCl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1055-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 320 mg due to CGMP deviations and the detection of a trace amount of the impurity N-nitrosodiethylamine (NDEA).

    Product
    Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1046-2019·2019-03-27

    AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1013-2019·2019-03-27

    Mylan Recalls Alprazolam Tablets Due to Elevated Impurity Levels

    Mylan Institutional, Inc. is recalling specific lots of Alprazolam Tablets, 0.25 mg, because elevated levels of a known impurity were detected during stability testing.

    Product
    Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1044-2019·2019-03-27

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

    Product
    Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1008-2019·2019-03-27

    FDA Recalls Volumex Iodinated I-131 Albumin Due to Sterility Concerns

    Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results exceeded limits, meaning sterility cannot be assured.

    Product
    VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1174-2019·2019-03-27

    Smoked Alaska Silver Salmon Recalled for Botulism Risk

    Smoked Alaska Seafoods is recalling 6.5 oz. jars and cans of Smoked Silver Salmon due to potential Clostridium botulinum contamination.

    Product
    Smoked Silver Salmon, brand Smoked Alaska, packaged in 6.5 oz. glass jars or cans. The product label is read in parts: "***SMOKED WILD ALASKA SILVER SALMON*** SMOKED ALASKA*** NET WT. 6.5 OZS. Ingredients: Natural Alder Smoked Silver Salmon, Brown Sugar, Salt *** PO BOX 87025
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1035-2019·2019-03-27

    Aurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan Tablets USP 320 mg because FDA analysis confirmed the presence of trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1024-2019·2019-03-27

    Advanced Pharma Recalls Neostigmine Methylsulfate Injection Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 5,700 syringes of Neostigmine Methylsulfate Injection Solution because there is a lack of assurance of sterility.

    Product
    Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1019-2019·2019-03-27

    Advanced Pharma Recalls Midazolam Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,125 bags of Midazolam Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1053-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 80 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.

    Product
    Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1039-2019·2019-03-27

    Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1049-2019·2019-03-27

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 50 mg, due to the presence of an impurity, N-Methylnitrosobutyric acid (NMBA).

    Product
    Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1031-2019·2019-03-27

    CTL Medical Hex Driver Recall Due to Anti-Toggle Ring Separation Risk

    CTL Medical is recalling 133 Hex Driver MIS units because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.

    Product
    CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1017-2019·2019-03-27

    Advanced Pharma Recalls Fentanyl Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 360 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1033-2019·2019-03-27

    Advanced Pharma Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 2,325 syringes of Morphine Sulfate 30 mg/30 mL Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1023-2019·2019-03-27

    Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 22,900 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1040-2019·2019-03-27

    Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Carcinogen

    Macleods Pharma USA is recalling specific bottles of Losartan Potassium and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active ingredient.

    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-1175-2019·2019-03-27

    Jansal Valley Chocolate Covered Almonds Recalled for Undeclared Sesame

    Friendly Fruit Market is recalling Jansal Valley Cocoa Dusted Chocolate Covered Almonds because the product contains undeclared sesame seeds.

    Product
    JANSAL VALLEY Cocoa Dusted Chocolate Covered Almonds, Net Weight: 6 OZ (170 G), packed in a plastic clamshell, UPC: 7 08152 32988 7
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1179-2019·2019-03-27

    Horizon Food Group Recalls Ne-Mo's Birthday Cake Squares Due to Foreign Object

    Horizon Food Group is recalling Ne-Mo's Birthday Cake Squares with Buttercream Icing after a complaint that a bird foot was found in the product.

    Product
    Ne-Mo's Birthday Cake Square with Buttercream Icing, item 506-6; Net Wt. 3 oz. Case UPC: 2007606405066 8 Display pk 6 ea/pk UPC: 10076064050660 1 Individual unit UPC: 07606405066 4 Frozen product has a shelf life of 365 days from the date of production Refrigerated product
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1027-2019·2019-03-27

    CP Medical Recalls Sterile Surgical Sutures Due to Potential Sterility Compromise

    CP Medical Inc is recalling Plain and Chromic Gut Absorbable Surgical Sutures because routine endotoxin testing showed an out-of-limit result, potentially compromising sterility.

    Product
    Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural ti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2019·2019-03-27

    Fujifilm FDR Go PLUS Mobile X-Ray System Recalled for Braking Defect

    Fujifilm is recalling 56 mobile X-ray systems because the braking mechanism may fail to engage when the handle is released.

    Product
    Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1173-2019·2019-03-27

    DAHlicious Organic Lassi Recalled for Improper Pasteurization

    DAHlicious is recalling 1,296 bottles of Organic Lassi Golden Turmeric due to improper pasteurization. Consumers should stop consuming the product.

    Product
    DAHlicious ORGANIC LASSI India-Style DRINKABLE YOGURT Golden Turmeric Lassi, 23 FL OZ (946 mL), UPC: 7 93573 01476 4.
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·19V241000·2019-03-27

    Volkswagen Recalls 2019 Tiguan LWB for Inaccurate Tire Information Label

    Volkswagen is recalling 2019 Tiguan LWB vehicles because the tire information label contains inaccurate dimension and pressure specifications, which may increase crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2019·2019-03-27

    Shimadzu Mobile X-Ray System Recalled for Brake Failure

    Shimadzu is recalling 93 MobileDaRt Evolution mobile X-ray systems because the brakes may fail to engage when the operator releases the drive handle.

    Product
    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V243000·2019-03-27

    Osco Recalls Emergency Vehicles With Faulty Brake Light Wiring

    Osco Tank & Truck Sales is recalling 16,342 emergency vehicles built on 2012 Kenworth T440 and 2018 Peterbilt 348 chassis because brake lights may illuminate without the pedal being pressed.

    Product
    KENWORTH — KENWORTH, PETERBILT T440, 348
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1177-2019·2019-03-27

    Horizon Food Group Recalls Ne-Mo's Chocolate Cake Squares Due to Foreign Object

    Horizon Food Group is recalling Ne-Mo's Chocolate Cake Squares with Cream Cheese Icing after a complaint of a bird foot found in the product.

    Product
    Ne-Mo's Chocolate Cake Square with Cream Cheese Icing, item 104; Net Wt. 3 oz. Case UPC: 2007606401046 4; Display pk 6 ea/pk UPC: 10076064010460 7 Individual unit UPC: 07606400104 8 Frozen product has a shelf life of 365 days from the date of production Refrigerated prod
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1180-2019·2019-03-27

    Best Choice Pancake Mix Recalled for Undeclared Milk Allergen

    Gilster-Mary Lee Corp. is recalling Best Choice Pancake & Waffle Complete Mix Original because the product contains milk but the packaging does not declare it as an ingredient.

    Product
    Best Choice Pancake & Waffle Complete Mix Original 32oz. retail carton, 12 retail units per wholesale case. UPC# 70038 30212
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1170-2019·2019-03-27

    Arbre Farms Organic Green Beans Recalled for Listeria Risk

    Arbre Farms, Inc. is recalling Organic Green Beans, 1" cut, IQF 1500# tote, due to a potential Listeria monocytogenes contamination.

    Product
    Organic Green Beans, 1" cut, IQF 1500# tote
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19V240000·2019-03-27

    Thor Motor Coach Recalls 2018-2020 Models Due to Reversed Backup Camera Image

    Thor Motor Coach is recalling 110 motorhomes because the backup camera image may reverse, increasing crash risk. Dealers will install a harness to fix the issue.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH FOUR WINDS, CHATEAU, MAGNITUDE, OMNI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1178-2019·2019-03-27

    Horizon Food Group Recalls Ne-Mo's Red Velvet Cake Squares Due to Foreign Object

    Horizon Food Group is recalling Ne-Mo's Red Velvet Cake Squares after a complaint of a bird foot found in the product.

    Product
    Ne-Mo's Red Velvet Cake Square with Cream Cheese Icing, item 408-6; Net Wt. 3 oz. Case UPC: 2007606404086 7 Display pk 6 ea/pk UPC: 10076064040860 0 Individual unit UPC: 07606400408 7 Frozen product has a shelf life of 365 days from the date of production Refrigerated pr
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1020-2019·2019-03-27

    FDA Recalls 850 Units of Covidien Force TriVerse Electrosurgical Devices

    The FDA is recalling 850 units of the Covidien Force TriVerse electrosurgical device due to potential sterile packaging compromise.

    Product
    Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19091·2019-03-27

    Cambridge Elevating Recalls Home Elevators Due to Fall Hazard

    Cambridge Elevating is recalling approximately 680 home elevators because the landing door can unlock without the elevator present, posing a fall hazard.

    Product
    Home elevators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2019·2019-03-27

    AAP Implantate Lambotte Chisel Recalled for Potential Breakage at Welded Parts

    AAP Implantate AG is recalling 25 units of the 20 mm Lambotte chisel due to a potential risk of breaking at the welded piece parts of the chisel body and knocking plate.

    Product
    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2019·2019-03-27

    ConvaTec Recalls Nelaton Urinary Catheters Due to Sterile Barrier Breach Risk

    ConvaTec is recalling Nelaton Urinary Catheters because an internal assessment found a potential breach in the sterile barrier, which could compromise the device's sterility.

    Product
    Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1065-2019·2019-03-27

    Heritage Pharmaceuticals Recalls Subpotent Etomidate Injection Vials

    Heritage Pharmaceuticals is recalling 11,888 vials of Etomidate Injection because the drug was found to be subpotent. The recall is voluntary and nationwide.

    Product
    Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1021-2019·2019-03-27

    Advanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 2,580 syringes of Glycopyrrolate Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1182-2019·2019-03-27

    Nova Salted Biscuit Recalled for Undeclared Milk Allergen

    Asia Food Distributor is recalling Nova Salted Biscuit because the product contains undeclared milk. Consumers should check their pantries for the specific lot.

    Product
    Nova Salted Biscuit The product comes in a 14.08 ounce, paper box marked with manufacturing date of Apr 2018 and expiration date of June 2020 stamped on the side.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2019·2019-03-27

    ConvaTec Recalls Feeding Tubes Due to Potential Sterile Barrier Breach

    ConvaTec is recalling specific lots of Feeding Tube Metric devices because an internal assessment found a potential breach in the sterile barrier.

    Product
    Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V244000·2019-03-27

    Toyota Recalls 2019 Models Due to Illegible Load Capacity Labels

    Toyota is recalling specific 2019 models because the load capacity label text may become illegible, potentially leading to vehicle overload and increased crash risk.

    Product
    TOYOTA — TOYOTA CAMRY, AVALON, PRIUS, RAV4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1181-2019·2019-03-27

    Lamb's Supreme Starz Potato Product Recalled for Foreign Material Contamination

    Lamb Weston is recalling Lamb's Supreme Starz star-shaped potato products due to contamination with foreign material. The recall affects specific lots distributed in the US and several international markets.

    Product
    Lamb's Supreme Starz, item S0026, is formed star-shaped potato product that has been par-fried and frozen. Product is packaged in a five-pound, food service, clear poly bag; the bags are boxed six bags per case (30 lbs net weight). Bags are placed in a corrugated cardboard case
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1035-2019·2019-03-27

    ConvaTec Recalls Forceps Blue Due to Potential Sterile Barrier Breach

    ConvaTec, Inc. is recalling Forceps Blue, disposable sterile forceps, because an internal assessment confirmed the potential for a breach in the sterile barrier.

    Product
    Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forcep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1032-2019·2019-03-27

    ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure

    ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick devices because a sample failed to meet tensile strength specifications.

    Product
    Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1033-2019·2019-03-27

    ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure

    ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick because a sample failed to meet tensile strength specifications.

    Product
    Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1029-2019·2019-03-27

    Smith & Nephew Recalls Mislabelled High Offset StikTite Coated Hip Stems

    Smith & Nephew is recalling 9 units of hip stems where the outer label incorrectly identified the product as size "1" instead of the actual size "-1".

    Product
    smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1017-2019·2019-03-27

    Randox Fructosamine Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 141 kits of Fructosamine Control 1 because the assigned value was decreased by 25%.

    Product
    Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1016-2019·2019-03-27

    Randox Fructosamine Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 85 kits of Fructosamine Calibrator FR2993 because the assigned value was decreased by 25%.

    Product
    Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1018-2019·2019-03-27

    Randox Fructosamine Control 3 Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 133 kits of Fructosamine Control 3 because the assigned value was decreased by 25%. The product is used for in vitro calibration.

    Product
    Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1011-2019·2019-03-27

    Akorn Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Low Potency

    Akorn Inc is recalling Hydrocortisone and Acetic Acid Otic Solution because routine stability testing revealed the drug was sub-potent.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1038-2019·2019-03-27

    ConvaTec Recalls FilterFlow Suction Handles Due to Sterile Barrier Breach Risk

    ConvaTec is recalling 124,000 FilterFlow Suction Handles because an internal assessment found a potential breach in the sterile barrier.

    Product
    FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1028-2019·2019-03-27

    Smith & Nephew Recalls Mislabelled Hip Stem Implants Due to Size Error

    Smith & Nephew is recalling 58 hip stem implants because the outer label incorrectly identified the product as size "1" instead of "-1".

    Product
    smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1014-2019·2019-03-27

    Siemens Dimension Vista 500 Analyzer Recall for Water Module Contamination

    Siemens is recalling 5,373 Dimension Vista 500 analyzers because specific Millipore water purification modules may cause falsely elevated triglyceride results.

    Product
    Dimension Vista 500, Analyzer, chemistry Model no. 10284473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1007-2019·2019-03-27

    Docusate Sodium Softgels Recalled Due to Incorrect Secondary Carton Labeling

    Rx Pak Division of McKesson Corporation is recalling Docusate Sodium 100mg softgels because secondary cartons may be mislabeled as Gabapentin 300mg.

    Product
    Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1015-2019·2019-03-27

    Siemens Dimension Vista 1500 Analyzer Recall Due to Water Module Contamination

    Siemens is recalling 5,373 Dimension Vista 1500 analyzers because specific water purification modules may cause falsely elevated triglyceride results.

    Product
    Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1026-2019·2019-03-27

    Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates

    Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.

    Product
    Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cav
    Category
    Medical Device
    Distribution
    Distributed nationwide

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