The Recall Desk

Archive

August 2017 recalls

1,004 recalls were announced in August 2017.

What the numbers show

Critical
75
Severe
178
High
462
Moderate
267
Low
22

Of the 1,004 recalls this month scored against our rubric, 7% are Critical, 18% are Severe.

Which agencies issued them

401–500 of 1004

  • ModerateFDA (Devices)·Z-3030-2017·2017-08-23

    CareFusion Recalls VersaSafe Plastic Cannulas Due to Packaging Punctures

    CareFusion 303, Inc. is recalling 1,546,800 units of VersaSafe Plastic Cannulas because punctures were detected in the blister packaging during the manufacturing process.

    Product
    VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Drugs)·D-1097-2017·2017-08-23

    Linde Eckstein Recalls Beautipharm Moisturizing Balm Due to SPF Labeling Concerns

    Linde Eckstein is recalling 478 bottles of Beautipharm All Day Moisturizing Balm SPF 10 because the SPF 10 protection claim cannot be fully guaranteed.

    Product
    Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1101-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim

    Linde Eckstein is recalling SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed. The product was distributed throughout the United States.

    Product
    Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03210, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032104.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1104-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Concerns

    Linde Eckstein is recalling specific lots of SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed.

    Product
    Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032401.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1107-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Sun Protection

    Linde Eckstein is recalling SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed. Consumers should stop using the product.

    Product
    Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03310, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033101.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1103-2017·2017-08-23

    Linde Eckstein Recalls Make Up Perfect Caramel SPF 10 Liquid Make-Up

    Linde Eckstein Gmbh + Co KG is recalling Make Up Perfect Caramel SPF 10 liquid make-up because the SPF 10 protection claim cannot be fully guaranteed.

    Product
    Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03330, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032302.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1105-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim

    Linde Eckstein Gmbh + Co KG is recalling SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed.

    Product
    Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03250, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032500.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1090-2017·2017-08-23

    Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

    Akorn Inc is recalling Halyard 24-Hour Oral Care Kits containing chlorhexidine gluconate oral rinse due to crystallization and subpotent assay results.

    Product
    Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1106-2017·2017-08-23

    Linde Eckstein Recalls Make Up Perfect Ivory SPF 10 Liquid Make-Up

    Linde Eckstein is recalling Make Up Perfect Ivory SPF 10 liquid make-up because the SPF 10 protection claim cannot be guaranteed.

    Product
    Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03300, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033002.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1083-2017·2017-08-23

    KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    KVK-Tech, Inc. is recalling specific lots of Phentermine Hydrochloride capsules because they failed impurity specifications during stability testing.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1109-2017·2017-08-23

    Linde Eckstein Recalls Make Up Perfect SPF 10 Liquid Make-up

    Linde Eckstein Gmbh + Co KG is recalling Make Up Perfect dark tan SPF 10 liquid make-up because the SPF 10 protection claim cannot be guaranteed.

    Product
    Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033408.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1110-2017·2017-08-23

    Linde Eckstein Recalls SPF 10 Liquid Make-Up Due to Subpotent Labeling

    Linde Eckstein is recalling Make Up Perfect terra SPF 10 liquid make-up because the sun protection factor claim cannot be fully guaranteed.

    Product
    Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03350, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033507.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1100-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Claims

    Linde Eckstein is recalling 373 bottles of SPF 10 liquid make-up because the sun protection claim cannot be guaranteed.

    Product
    Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03200, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032005.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1098-2017·2017-08-23

    Linde Eckstein Recalls Beautipharm Body Moisturizing Balm Due to Subpotent SPF

    Linde Eckstein is recalling Beautipharm Body Moisturizing Balm SPF 10 because the sun protection factor claim cannot be fully guaranteed.

    Product
    Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 250 ml bottle, Art. 03150 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031503.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1099-2017·2017-08-23

    Linde Eckstein Recalls Beautipharm Eye Care Balm Due to SPF Labeling Concerns

    Linde Eckstein is recalling 73 bottles of Beautipharm Eye Care Balm SPF 10 because the sun protection factor claim cannot be fully guaranteed.

    Product
    Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1089-2017·2017-08-23

    Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

    Akorn Inc is recalling Halyard 24-Hour Oral Care Kits containing chlorhexidine gluconate oral rinse due to crystallization and subpotent assay results.

    Product
    Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1102-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim

    Linde Eckstein is recalling specific lots of SPF 10 liquid make-up because the sun protection factor claim cannot be fully guaranteed.

    Product
    Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032203.
    Category
    Drug
    Distribution
    0 states
  • CriticalUSDA FSIS·094-2017·2017-08-22

    Fair Oaks Farms Recalls Pork Sausage Patties Due to Listeria Risk

    Fair Oaks Farms is recalling fully cooked pork sausage patties due to possible Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Fair Oaks Farms, LLC Recalls Pork Sausage Patties Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·17V516000·2017-08-22

    GM Recalls 2017-2018 Acadia, Equinox, and Terrain for Driveshaft Fracture

    General Motors is recalling 2017-2018 GMC Acadia, 2018 Chevrolet Equinox, and 2018 GMC Terrain vehicles because the right front intermediate driveshaft may fracture and separate while driving.

    Product
    GMC — GMC, CHEVROLET ACADIA, EQUINOX, TERRAIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17763·2017-08-22

    Polaris Recalls 2017 GENERAL ROVs Due to Tire Pressure Crash Hazard

    Polaris is recalling about 1,600 2017 GENERAL Base and Hunter recreational off-highway vehicles because inconsistent tire pressure information can lead to improperly inflated tires and a crash hazard.

    Product
    GENERAL recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V515000·2017-08-18

    IMT Recalls 2016-2017 Dominator Trucks Due to Electrical Short Risk

    Iowa Mold Tooling is recalling 2016-2017 Dominator Contractor trucks because a fuse block may contact the hood, creating an electrical short that increases fire risk.

    Product
    IMT — IMT DOMINATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V511000·2017-08-18

    Heartland Recalls 2018 Pioneer Trailers Due to Propane Hose Leak Risk

    Heartland is recalling 2018 Pioneer recreational trailers because the liquid propane hose may not be secured, allowing the tire to rub through it and cause a leak.

    Product
    HEARTLAND — HEARTLAND PIONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V513000·2017-08-18

    Forest River Recalls 2018 RVs with Incorrect Tire Pressure Labels

    Forest River is recalling 2018 Dynamax, Forester, Sunseeker, and Coachmen Prism vehicles because B-pillar tire labels list pressures that are too low.

    Product
    COACHMEN — COACHMEN, FOREST RIVER PRISM, DYNAMAX, FORESTER, SUNSEEKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V510000·2017-08-17

    Blue Bird Recalls School Buses Due to Unpadded Seat Studs

    Blue Bird is recalling 2015-2019 Vision and 2016 All American school buses because unpadded seat studs may cause head injuries in rear crashes.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·17V512000·2017-08-17

    Tiny Idahomes Recalls RVs and Trailers with Incorrect Weight Labels

    Tiny Idahomes is recalling 2014-2017 RVs and trailers because the Federal Placard may display an incorrect Gross Vehicle Weight Rating (GVWR). Owners will receive corrected labels by mail.

    Product
    TINY IDAHOMES — TINY IDAHOMES, RUGGED MOUNTAIN CUSTOM RV CARGO TRAILER, LINCOLN PEAK, CHINOOK PEAK, CASTLE PEAK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2099-2017·2017-08-16

    Cook Medical Recalls Zenith Alpha Thoracic Endovascular Grafts

    Cook Medical is recalling Zenith Alpha Thoracic Endovascular Grafts due to reports of graft thrombosis and occlusion, including one patient death.

    Product
    Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1066-2017·2017-08-16

    Cantrell Recalls Glycopyrrolate Injection Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling 21,080 syringes of Glycopyrrolate Injection Solution due to a lack of sterility assurance.

    Product
    Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1073-2017·2017-08-16

    Cantrell Drug Recalls Diltiazem HCl Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling Diltiazem HCl 125 mg in 5% Dextrose single-dose bags because of a lack of sterility assurance. The recall covers 2,761 bags distributed nationwide.

    Product
    Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1071-2017·2017-08-16

    Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling 1,718 bags of Norepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL due to a lack of sterility assurance.

    Product
    Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1072-2017·2017-08-16

    Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling 3,039 bags of Norepinephrine Bitartrate 4 mg in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3350-2017·2017-08-16

    Sunneen Recalls Whole Foods PB & J Parfaits for Allergen Mislabeling

    Sunneen Health Foods is recalling Whole Foods Market PB & J Parfaits because the ingredient label failed to declare soy, almonds, and coconut allergens.

    Product
    Whole Foods Market PB & J Parfait Made With Greek Yogurt; Net Wt 8 OZ.;
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1079-2017·2017-08-16

    Cantrell Drug Company Recalls Rocuronium Bromide Injection Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Rocuronium Bromide Injection Solution due to a lack of sterility assurance. The affected syringes were distributed nationwide in the US.

    Product
    Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1067-2017·2017-08-16

    Cantrell Drug Recalls Glycopyrrolate Injection Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Glycopyrrolate Injection Solution due to a lack of sterility assurance. The affected syringes were distributed nationwide.

    Product
    Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1076-2017·2017-08-16

    Cantrell Drug Recalls Adenosine Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling Adenosine in 0.9% Sodium Chloride syringes due to a lack of sterility assurance.

    Product
    Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-236-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1070-2017·2017-08-16

    Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling 8,928 bags of Norepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL due to a lack of sterility assurance.

    Product
    Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1065-2017·2017-08-16

    Cantrell Recalls Glycopyrrolate Injection Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling 75,840 syringes of Glycopyrrolate Injection Solution nationwide because of a lack of sterility assurance.

    Product
    Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3364-2017·2017-08-16

    Bliss Microcreamery Recalls Ice Cream for Undeclared Egg Allergen

    Bliss Microcreamery is recalling J.J. Lawson Chocolate Chip Ice Cream because it contains undeclared egg yolk.

    Product
    J.J. LAWSON CHOCOLATE CHOC. CHIP ICE CREAM, 3 gallon round container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-3354-2017·2017-08-16

    Garden of Light Recalls Organic Matcha Vanilla Oats for Listeria Risk

    Garden of Light Inc. is recalling Woodstock Organic Matcha Vanilla Oats due to potential Listeria contamination. Consumers should check lot codes and stop eating the product.

    Product
    WOODSTOCK ORGANIC MATCHA VANILLA OATS, 1.8 oz (50g) cup UPC: 0-42563-01786-6
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1068-2017·2017-08-16

    Cantrell Drug Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride Injection Solution due to a lack of sterility assurance.

    Product
    Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1074-2017·2017-08-16

    Cantrell Drug Recalls Phenylephrine Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Phenylephrine HCL syringes because they may lack sterility assurance. The affected products were distributed nationwide.

    Product
    Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1069-2017·2017-08-16

    Cantrell Drug Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride Injection Solution due to a lack of sterility assurance.

    Product
    Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1075-2017·2017-08-16

    Cantrell Drug Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Sodium Bicarbonate 8.4% Injection Solution because of a lack of sterility assurance.

    Product
    Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1064-2017·2017-08-16

    Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling Ephedrine Sulfate syringes due to a lack of sterility assurance. The recall covers 49,666 syringes distributed nationwide.

    Product
    Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1062-2017·2017-08-16

    Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling Ephedrine Sulfate in 0.9% Sodium Chloride single-dose syringes because of a lack of sterility assurance.

    Product
    Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1078-2017·2017-08-16

    Cantrell Recalls Neostigmine Methylsulfate Injection Due to Sterility Concerns

    Cantrell Drug Company is recalling Neostigmine Methylsulfate Injection Solution due to a lack of sterility assurance. The affected syringes were distributed nationwide.

    Product
    Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1063-2017·2017-08-16

    Cantrell Drug Company Recalls Ephedrine Sulfate Injection Syringes

    Cantrell Drug Company is recalling 7,656 syringes of Ephedrine Sulfate Injection Solution due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1061-2017·2017-08-16

    Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Ephedrine Sulfate syringes due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3353-2017·2017-08-16

    McCain Onion Ring Batter Recalled for Undeclared Milk Allergen

    McCain Foods Canada is recalling frozen onion ring batter in Puerto Rico due to an undeclared milk allergen from a raw ingredient.

    Product
    MCCAIN ONION RING BATTERED PORTION PERFECT ¿ 60X4 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2871-2017·2017-08-16

    Sorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip

    Sorin Group USA, Inc. is recalling Aortic Arch Cannulas due to the identification of excess plastic on the tip of the device.

    Product
    Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3351-2017·2017-08-16

    Coborn's Gluten Free Fudge Brownies Recalled for Milk Mislabeling

    Coborn's is recalling Gluten Free Fudge Brownies because some were incorrectly labeled and contain milk, posing a risk to those with milk allergies.

    Product
    Fudge Brownie, Net Wt. 9 oz. (0.6 lb.) (255g), with the following brands: 1. Cashwise Gluten Free Bakery, 2. Coborn's Gluten Free Bakery.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2897-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Set Screws for Quality System Non-Compliance

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Set Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Set Screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2872-2017·2017-08-16

    C.R. Bard Recalls Leg Bags Due to Potential Sterile Barrier Breach

    C.R. Bard is recalling 2,350 units of Bard Dispoz-A-Bag leg bags due to a reported cut in the side that may compromise the sterile barrier.

    Product
    BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.

    Product
    Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2821-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Hypodermic Needle, 27 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V508000·2017-08-16

    Audi Recalls 2017-2018 A3 Models Due to Engine Stall Risk

    Volkswagen Group of America is recalling 2017-2018 Audi A3 Cabriolet and Sedan vehicles because engine software may cause the engine to stall, increasing crash risk.

    Product
    AUDI — AUDI A3 CABRIOLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V507000·2017-08-16

    BMW Recalls 2018 M4, 430i, and 440i Convertibles for Seat Belt Defect

    BMW is recalling 2018 M4, 430i, and 440i convertibles because front seat belts may fail to restrain occupants in a crash. Dealers will inspect and replace affected assemblies free of charge.

    Product
    BMW — BMW M4, 430I, 440I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3360-2017·2017-08-16

    Publix GreenWise Cashew Butter Recalled for Potential Almond Content

    Publix Supermarkets is recalling approximately 414 jars of GreenWise Cashew Butter because some jars may contain almond butter instead.

    Product
    Publix Greenwise Cashew Butter, NET WT 16 oz (1 lb) 454g, Distributed by Publix Super Markets, Inc, Lakeland, FL 33802
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2910-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Polyaxial Spinal Screws

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS polyaxial screws due to quality system non-compliance. The devices are intended for spinal fixation.

    Product
    PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3357-2017·2017-08-16

    ISABEL Recalls Octopus Cans Containing Squid Due to Mislabeling

    ISABEL North America is recalling 4-ounce cans of octopus in vegetable oil because the product actually contains squid. This mislabeling poses a risk to consumers with seafood allergies.

    Product
    ISABEL, Octopus in vegetable oil, Pulpo en aceite vegetal, Net wt - Peso Neto 4 oz(115g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2812-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17T014000·2017-08-16

    Triangle Tire USA Recalls TR643 Tires Due to Air Leak Risk

    Triangle Tire USA is recalling specific TR643 tires for cargo and recreational trailers due to a mold irregularity that causes air leaks, increasing the risk of tire failure and crashes.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2898-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17762·2017-08-16

    FedEx Supply Chain Recalls Counterfeit Cellphone Batteries for Fire Risk

    FedEx Supply Chain is recalling about 10,200 counterfeit batteries in refurbished AT&T Samsung Galaxy Note 4 phones due to overheating, fire, and burn hazards.

    Product
    Batteries in refurbished cellphones
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2813-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2815-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support its product sterility claims.

    Product
    Hypodermic Needle, 22 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2932-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2807-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 18 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2933-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2886-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 50mm MIS Rods for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 50mm MIS Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2843-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because of insufficient documentation to support sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2959-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 400mm Straight Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 400mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2940-2017·2017-08-16

    Valorem Surgical Recalls Pallas M 35mm Curved Rods for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M 35mm Curved Rods because they do not meet FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2930-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2989-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Extension Guide Bushes for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Guide Bushes because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Extension Guide Bush. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2844-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2947-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 35mm Straight Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 35mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 35mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2968-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Anti Torque Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Anti Torque devices due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2809-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.

    Product
    Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2993-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Anti Torque Devices for Quality Issues

    Valorem Surgical is recalling 262 Pallas M/MAXIMIS Anti Torque Devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Anti Torque Device. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2949-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 45mm Straight Rods

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 45mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2937-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3008-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Nut Inserters for Quality System Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Nut Inserters because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Nut Inserter B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2853-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the product's sterility claims.

    Product
    Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2917-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2834-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2996-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Checkers for Quality System Defects

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Checkers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Rod Checker. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2873-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Instrument Taps for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 5.5 mm Instrument Taps because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2938-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2972-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Marking Pins for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Marking Pins because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Marking Pin (Smooth). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2833-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2990-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Extension Sleeves for Quality System Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Sleeves because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Extension Sleeve. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2908-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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