The Recall Desk

Archive

November 2016 recalls

802 recalls were announced in November 2016.

What the numbers show

Critical
61
Severe
132
High
403
Moderate
173
Low
33

Of the 802 recalls this month scored against our rubric, 8% are Critical, 16% are Severe.

Which agencies issued them

601–700 of 802

  • HighFDA (Devices)·Z-0333-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0322-2017·2016-11-09

    Medtronic Recalls Visualase Visualization Stylets Due to MRI Magnetic Attraction

    Medtronic Navigation is voluntarily recalling Visualase Visualization Stylets because they bend or pull toward magnetic fields during MRI procedures.

    Product
    Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0330-2017·2016-11-09

    Azer Scientific Recalls Fruit Punch Glucose Due to Microbiological Test Failures

    Azer Scientific is recalling Fruit Punch Glucose, 100 Gram Concentration, due to out-of-specification microbiological test results.

    Product
    Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0354-2017·2016-11-09

    Hospira Symbiq Infusion Pumps Recalled for Backup Battery Failure

    Hospira is recalling Symbiq Two Channel Infusers due to a backup battery failure caused by incorrect component installation on some power supply boards.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0332-2017·2016-11-09

    Spacelabs Xhibit Central Station Recalled for Telemetry Display Issues

    Spacelabs Healthcare is recalling 348 Xhibit Central Station units because telemetry SpO2 numerics may drop off the display, though alarms function normally.

    Product
    Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0355-2017·2016-11-09

    Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk

    Unomedical As is recalling 1.3 million Comfort infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0340-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0356-2017·2016-11-09

    Unomedical Recalls Insulin Infusion Sets Due to Tubing Detachment Risk

    Unomedical As is voluntarily recalling 664,000 Contact Detach infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0382-2017·2016-11-09

    Beverage International Recalls Nu-Quench Lime Bar Mix Due to Undeclared Dye

    Beverage International is recalling Nu-Quench Lime Bar Mix because it contains undeclared Yellow #5, a potential allergen for sensitive individuals.

    Product
    Nu-Quench Lime Bar Mix 32 Oz. packaged in plastic bottle, 12 bottles per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0339-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0324-2017·2016-11-09

    Stryker Recalls Reprocessed Pressure Tourniquet Cuffs Due to Leak Detection Issues

    Stryker Sustainability Solutions is recalling 1,695,760 reprocessed pressure tourniquet cuffs because the process for detecting leaks is flawed. Leaking cuffs may cause excessive blood loss or systemic leakage of local anesthetic.

    Product
    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2017·2016-11-09

    Maquet HCU 30 Heater-Cooler Units Recalled for Bacterial Contamination Risk

    Maquet Cardiovascular is recalling 305 HCU 30 units because contaminated water, including Mycobacteria, may enter the device circuits.

    Product
    Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2017·2016-11-09

    Stryker Recalls Guider Guide Catheters Due to Manufacturing Defect

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing non-conformance that could lead to hub leaks.

    Product
    Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0341-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0347-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks in the devices.

    Product
    Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0321-2017·2016-11-09

    JJBL LLC Recalls Chocolate Bars Due to Undeclared Wheat

    JJBL LLC is recalling The Most Awesome Chocolate Bar Ever because the product contains undeclared wheat. The recall affects 2,214 bars distributed in 11 states.

    Product
    The Most Awesome Chocolate Bar Ever, Net wt. 1.5 oz. UPC 8 55966 00178 9.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0350-2017·2016-11-09

    Smith & Nephew Recalls Tandem Hip Shells With Out-of-Specification Grooves

    Smith & Nephew is recalling 2,352 Tandem hip shells manufactured with out-of-specification retainer grooves. The recall covers units distributed nationwide and in 23 other countries.

    Product
    TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0379-2017·2016-11-09

    Frontera Taco Skillet Sauce Recalled for Undeclared Soy

    Riba Foods Inc is recalling Frontera Texas Original Taco Skillet Sauce due to potential undeclared soy from soy sauce.

    Product
    Frontera Texas Original Taco Skillet Sauce with mild red chile + cumin 8 oz. pouch
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0311-2017·2016-11-09

    Fanega Flour Tortillas Recalled for Undeclared Wheat Allergen

    Fanega Mexican Food Products is recalling 10-inch flour tortillas sold in Arizona because they contain undeclared wheat.

    Product
    10" Flour Tortillas 12 count, Net Wt. 25oz (732g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0360-2017·2016-11-09

    Unomedical Recalls SureT G29 Insulin Infusion Pump Tubing Due to Detachment Risk

    Unomedical As is voluntarily recalling SureT G29 insulin infusion pump tubing because it may detach. The recall covers 4,748,000 units distributed in the US and internationally.

    Product
    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0353-2017·2016-11-09

    Hospira Recalls Symbiq Infusion Pumps Due to Backup Battery Failure

    Hospira is recalling 20,311 Symbiq One Channel Infusion Pumps due to a backup battery failure caused by incorrect component installation on some power supply boards.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2017·2016-11-09

    Smith & Nephew Recalls Tandem Hip Shells With Out-of-Specification Grooves

    Smith & Nephew is recalling 5,806 Tandem hip shell units manufactured with out-of-specification retainer grooves. The recall covers distribution in the US and 23 other countries.

    Product
    TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2017·2016-11-09

    Unomedical Silhouette Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling Silhouette and Silhouette Paradigm insulin infusion tubing due to a risk of tubing detachment. The recall affects approximately 9.8 million units distributed in the US and internationally.

    Product
    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0329-2017·2016-11-09

    Azer Scientific Recalls Glucose Tolerance Beverage Due to Microbiological Test Failures

    Azer Scientific, Inc. is recalling 426 cases of Orange Glucose Tolerance Beverage due to out-of-specification microbiological test results.

    Product
    Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2017·2016-11-09

    Medtronic Visualase Body Accessory Kit Recalled for MRI Safety Hazard

    Medtronic Navigation is recalling Visualase Body Accessory Kits because the visualization stylet bends in MRI magnetic fields.

    Product
    Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0086-2017·2016-11-09

    Epimed 15 g R.K. Epidural Needle Recall for Catheter Coating Risk

    Epimed International is recalling 576 units of 15 g R.K. Epidural Needles because they may skive a catheter's outer coating, posing a risk of retained catheter fragments.

    Product
    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0124-2017·2016-11-09

    Akorn Recalls Subpotent Sodium Chloride Ophthalmic Solution

    Akorn Inc. is recalling 29,972 bottles of 5% Sodium Chloride Ophthalmic Solution because the product concentration is less than the labeled amount.

    Product
    Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0119-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1.5/30 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers specific lots distributed nationwide and in Puerto Rico.

    Product
    Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0321-2017·2016-11-09

    Mindray TD60 Display Telemetry Transmitter Recalled for Bezel Cracking and Power Issues

    Mindray is recalling 1,278 TD60 Display Telemetry Transmitters because the bezel may crack or the device may fail to power on.

    Product
    TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0331-2017·2016-11-09

    Arrow Hands-Off Infusion Port Thermodilution Catheter Recalled for Labeling Inconsistency

    Arrow International Inc is recalling specific lots of Hands-Off Infusion Port Thermodilution Catheters due to a labeling inconsistency. The recall covers 330 units in the US and 1,031 units outside the US.

    Product
    HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0343-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0338-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF Guide Catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0120-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1/20 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers 393,981 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0123-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 24 FE 1.5/30 Oral Contraceptives

    Par Pharmaceutical is recalling Gildess 24 FE 1.5/30 oral contraceptives because the ethinyl estradiol component is subpotent. The recall covers 44,127 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0377-2017·2016-11-09

    Rikki USA Recalls Sallere Hollandaise Sauce Due to Mold Presence

    Rikki USA, Inc. is recalling Sallere Classic Sauces and Butters Hollandaise Sauce because of mold. The product was distributed in Maryland and Oregon.

    Product
    Hollandaise Sauce, sold as Sallere Classic Sauces and Butters, refrigerated product. Each plastic tub has a net wt 7 oz. The label is read in parts: "***HOLLANDAISE SAUSE***Use on chicken, seafood and vegetables***.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0117-2017·2016-11-09

    Taro Recalls Desoximetasone Cream Due to Stability Test Failures

    Taro Pharmaceuticals is recalling specific lots of Desoximetasone Cream 0.05% because they failed stability specifications for homogeneity.

    Product
    DESOXIMETASONE — DESOXIMETASONE (DESOXIMETASONE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0327-2017·2016-11-09

    B. Braun Recalls Spinal Anesthesia Trays with Lidocaine Component

    B. Braun Medical is voluntarily recalling specific lots of Custom Spinal Anesthesia Trays because the lidocaine component does not meet color specifications.

    Product
    Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0335-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters for Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF Guide Catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0345-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0334-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Drugs)·D-0121-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1/20 tablets because the ethinyl estradiol component is subpotent. The recall covers 822,009 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0118-2017·2016-11-09

    Actavis Recalls Ramipril Capsules Due to Incorrect Expiration Date Labeling

    Actavis is recalling 15,984 bottles of Ramipril Capsules because they were labeled with an incorrect expiration date of 03/18 instead of 09/17.

    Product
    Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0122-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1.5/30 tablets because they may contain subpotent levels of ethinyl estradiol.

    Product
    Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·105-2016·2016-11-08

    Water Lilies Food Recalls Egg Rolls Due to Undeclared Shrimp Allergen

    Water Lilies Food Inc. is recalling approximately 1,710 pounds of egg rolls because they contain undeclared shrimp and are mislabeled as pork.

    Product
    Water Lilies Food, LLC — Water Lilies Food Inc. Recalls Egg Roll Product Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·104-2016·2016-11-08

    Klement's Recalls Beef and Pork Snack Sticks Due to Foreign Matter

    Klement's Sausage Company is recalling 1,689 pounds of beef and pork snack sticks due to possible foreign matter contamination. One oral injury has been reported.

    Product
    Milwaukee Craft Meats, LLC., d/b/a Klement's Sausage Company — Klement's Sausage Company, Inc. Recalls Beef and Sausage Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·16V810000·2016-11-08

    Newmar Recalls 2017 Motorhomes Due to Throttle Circuit Wire Interference

    Newmar is recalling 51 model year 2017 motorhomes because throttle circuit wires may not be twisted, potentially causing unintended acceleration or deceleration.

    Product
    NEWMAR — NEWMAR LONDON AIRE, MOUNTAIN AIRE, KING AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V812000·2016-11-08

    Hyundai Translead Recalls 2012-2013 HT Trailers Due to Cracking I-Beams

    Hyundai Translead is recalling 892 model year 2012-2013 HT trailers because I-beams may crack, potentially causing the bogie to detach and increasing crash risk.

    Product
    HYUNDAI TRANSLEAD — HYUNDAI TRANSLEAD HT HYCUBE, HT ORIGINAL, HT COMPOSITE-XT, HT COMPOSITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17709·2016-11-08

    Trane Recalls Furnaces Due to Electrical Shock Hazard

    Trane is recalling about 17,700 furnaces because a loose ground wire creates a shock hazard if an electrical component fails.

    Product
    Furnaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V813000·2016-11-08

    Chrysler Recalls 2016 Dodge Dart for Windshield Wiper Circuit Failure

    Chrysler is recalling 53,155 2016 Dodge Dart vehicles because a faulty washer pump can cause the wiper circuit to fail, reducing visibility and increasing crash risk.

    Product
    DODGE — DODGE DART
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V809000·2016-11-07

    Daimler Trucks Recalls 2016-2017 FCCC Chassis for Fire Risk

    Daimler Trucks is recalling 1,827 model year 2016-2017 FCCC recreational vehicle chassis because an incorrectly routed power steering hose may cause electrical arcing and a fire.

    Product
    FCCC — FCCC XCR, XCM, XCL, XBR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V806000·2016-11-07

    Terex Advance Front Discharge Concrete Mixers Recalled for Axle Defect

    Terex Advance is recalling 2016-2017 Front Discharge Concrete Mixers because a front axle king-pin may fracture, potentially causing wheel separation and loss of vehicle control.

    Product
    TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE CONCRETE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·103-2016·2016-11-06

    OSI Industries Recalls Chicken Patties Due to Foreign Matter

    OSI Industries is recalling approximately 21,403 pounds of frozen chicken patties that may contain blue plastic fragments.

    Product
    OSI Industries, LLC — OSI Industries, LLC Recalls Chicken Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·16V802000·2016-11-04

    GM Recalls 2017 Cadillac XT5 and GMC Acadia for Brake Caliper Defect

    General Motors is recalling 2017 Cadillac XT5 and GMC Acadia vehicles because front brake caliper seals may leak fluid, reducing braking performance.

    Product
    CADILLAC — CADILLAC, GMC XT5, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V804000·2016-11-04

    PTIC Recalls Stratos Asphalt Distributor Trailers Due to Axle Overload Risk

    PTIC is recalling 2014-2016 Stratos asphalt distributor trailers because fully loaded weight may exceed axle capacity, risking bearing overheating or hub detachment.

    Product
    STRATOS — STRATOS DMD-1000, DMT-1000, DMD-600, DMD-400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V803000·2016-11-04

    PACCAR Recalls 2017 Peterbilt and Kenworth Trucks for Tire Defect

    PACCAR is recalling 2017 Peterbilt and Kenworth trucks equipped with specific Goodyear tires that may partially separate, increasing crash risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 389, 337, 330, T660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V805000·2016-11-04

    Terex Recalls 2009-2014 TC and TCX Trucks for Wiring Defect

    Terex is recalling 2009-2014 TC and TCX hybrid electric trucks because improper wiring may cause the aerial boom to move unintentionally, increasing the risk of injury.

    Product
    TEREX — TEREX TC, TCX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·102-2016·2016-11-03

    Flavor Trade Recalls Beef Jerky Produced Without Federal Inspection

    Flavor Trade, LLC. is recalling approximately 113 pounds of beef jerky produced without federal inspection and bearing unauthorized USDA marks.

    Product
    Flavor Trade, LLC. Recalls Beef Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·16V801000·2016-11-03

    E-One Recalls 2014-2016 Fire Trucks Due to Hydraulic Leak Risk

    E-One is recalling 2014-2016 Typhoon, Quest, and Cyclone fire trucks equipped with aerial ladders because a filter design change may cause hydraulic fluid leaks.

    Product
    E-ONE — E-ONE CYCLONE, TYPHOON, QUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17027·2016-11-03

    KTM and Husqvarna Recall Off-Road Motorcycles Due to Brake Malfunction

    KTM North America is recalling about 1,200 model year 2017 KTM and Husqvarna off-road motorcycles because the front brake master cylinder can malfunction, posing a crash hazard.

    Product
    Closed-course/competition off-road motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0236-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Herring in Sourcream Due to Listeria Risk

    SM Fish Corp. is recalling 168 units of Ossie's Herring in Sourcream due to potential Listeria monocytogenes contamination found in the facility.

    Product
    OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114714; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0241-2017·2016-11-02

    SM Fish Corp. Recalls Dublin Herring for Listeria Contamination Risk

    SM Fish Corp. is recalling 110 units of Ossie's Dublin Herring due to potential Listeria monocytogenes contamination found in the plant.

    Product
    OSSIE'S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0253-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Egg with Scallion Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Egg with Scallion in New York and New Jersey because FDA testing found Listeria monocytogenes in the facility.

    Product
    OSSIE'S EGG WITH SCALLION, NET WT. 7 OZ., UPC 73988570555; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0242-2017·2016-11-02

    SM Fish Corp. Recalls Honey Mustard Herring for Listeria Risk

    SM Fish Corp. is recalling 105 units of Ossie's Honey Mustard Herring due to potential Listeria monocytogenes contamination found in the facility.

    Product
    OSSIE'S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0247-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Pickled Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Herring Clear due to potential Listeria monocytogenes contamination found in the facility.

    Product
    OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0368-2017·2016-11-02

    Ferrara Recalls Brach's Chocolate Almonds for Undeclared Peanuts and Wheat

    Ferrara Candy Comp is recalling Brach's Chocolate Creations Milk Chocolate Almond Supremes due to undeclared peanuts and wheat.

    Product
    BRACH'S Chocolate Creations, Milk Chocolate Almond Supremes, Fresh roasted almonds drenched in rich creamy milk chocolate. NET WT 5 oz (142 g). Best By 04/22/2017
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Food)·F-0244-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Shmaltz Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Shmaltz Herring because FDA environmental sampling found Listeria monocytogenes in the facility.

    Product
    OSSIE'S SHMALTZ HERRING, NET WT. 8 OZ., UPC 739885104182; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-0116-2017·2016-11-02

    St Jude Medical Recalls Implantable Defibrillators Due to Battery Defect

    St Jude Medical is recalling specific implantable defibrillators because a lithium cluster in the battery can cause a short circuit and premature depletion.

    Product
    Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0249-2017·2016-11-02

    SM Fish Corp. Recalls OSSIE'S LITE TUNA Due to Listeria Risk

    SM Fish Corp. is recalling OSSIE'S LITE TUNA in 7-ounce plastic deli tubs due to potential Listeria monocytogenes contamination found in the plant.

    Product
    OSSIE'S LITE TUNA, NET WT. 7 OZ., UPC 73988570551; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0250-2017·2016-11-02

    SM Fish Corp. Recalls Tuna Salad for Listeria Contamination Risk

    SM Fish Corp. is recalling 534 units of Ossie's Home Made Tuna Salad due to potential Listeria monocytogenes contamination found in the facility.

    Product
    OSSIE'S HOME MADE TUNA SALAD, NET WT. 7 OZ., UPC 73988570550; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0097-2017·2016-11-02

    Roche Recalls cobas 8000 Analyzers Due to Sharp Edge Injury Reports

    Roche is recalling cobas 8000 Modular Analyzers and e602 Immunoassay Analyzers after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0300-2017·2016-11-02

    Ortho-Clinical Diagnostics Recalls enGen Laboratory Automation System Due to Sample Error

    Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System because a software error may cause sample identification to be mismatched with assay results.

    Product
    enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0246-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Pickled Herring Due to Listeria Risk

    SM Fish Corp. is recalling 167 units of Ossie's Pickled Herring in New York and New Jersey due to potential Listeria monocytogenes contamination found in the plant.

    Product
    OSSIE'S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0109-2017·2016-11-02

    Roche Recalls cobas p 312 Pre-Analytical System Calculator Modules

    Roche is recalling 9,014 cobas p 312 Pre-Analytical System calculator/data processing modules due to four reported injuries caused by a sharp edge on the sample rack tray.

    Product
    cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0101-2017·2016-11-02

    Roche Recalls cobas p 701 Post-Analytical Units Due to Sharp Edges

    Roche is recalling 9,014 cobas p 701 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0107-2017·2016-11-02

    Roche Recalls cobas p 512 Pre-Analytical Instrument Due to Sharp Edge Injury Reports

    Roche is recalling 9,014 cobas p 512 Pre-Analytical Instruments after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0105-2017·2016-11-02

    Roche Recalls cobas 8000 Sorting System Modules Due to Injury Reports

    Roche is recalling 9,014 cobas 8000 Sorting System calculator/data processing modules after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0102-2017·2016-11-02

    Roche Recalls cobas p 501 Post-Analytical Units Due to Sharp Edges

    Roche is recalling 9,014 cobas p 501 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0280-2017·2016-11-02

    McCormick Taco Seasoning Mix Recalled for Undeclared Milk

    McCormick is recalling Club Size Original Taco Seasoning Mix due to undeclared milk. The recall covers 14,570 containers distributed nationwide.

    Product
    Club Size McCormick Original Taco Seasoning Mix 24 oz. , CASE PACK: 12/case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0229-2017·2016-11-02

    Regalo Bakery Recalls Spanish Rolls for Undeclared Allergens

    Regalo Bakery is recalling Spanish Rolls because the product contains undeclared eggs, wheat, milk, soy, and artificial food coloring.

    Product
    Regalo Bakery: "Spanish Rolls"[UPC#78253230919]: Packaged in a clear plastic bag, containing eight pieces, with a net weight of 14 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0231-2017·2016-11-02

    Regalo Bakery Recalls Manju Onions for Undeclared Allergens

    Regalo Bakery is recalling Manju Onions (Hopia Baboy) because the product contains undeclared eggs, wheat, soy, and artificial food coloring.

    Product
    Regalo Bakery: "Manju Onions (Hopia Baboy)" [UPC#78253230918]: packaged on a foam tray with six pieces each, wrapped in clear plastic film. This product contains: eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0096-2017·2016-11-02

    Roche Recalls cobas 6000 Series Analyzers Due to Sharp Edge Injury Risk

    Roche is recalling cobas 6000 Series analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.

    Product
    cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0238-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Stiglitz Herring Due to Listeria Risk

    SM Fish Corp. is recalling 108 units of Ossie's Stiglitz Herring in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0117-2017·2016-11-02

    St Jude Medical Recalls ICD and CRT-D Devices for Battery Short Circuit

    St Jude Medical is recalling implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators due to a battery defect that can cause premature depletion.

    Product
    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0243-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk

    SM Fish Corp. is recalling 170 units of Ossie's Pickled Lox & Cream in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·16V797000·2016-11-02

    Isuzu and Chevrolet Trucks Recalled for Stuck Accelerator Pedal Risk

    Isuzu is recalling 2014-2016 NPR, NPR HD, and 2016 Chevrolet Low Cab Forward 3500/4500 trucks because the throttle pedal may get stuck, causing high speeds and crash risk.

    Product
    CHEVROLET — CHEVROLET, ISUZU LOW CAB FORWARD 4500, NPR HD, LOW CAB FORWARD 3500, NPR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0240-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Swedish Matjes Herring for Listeria Risk

    SM Fish Corp. is recalling 100 units of Ossie's Swedish Matjes Herring in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S SWEDISH MATJES HERRING, NET WT. 7 OZ., UPC 739885109101; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0230-2017·2016-11-02

    Regalo Bakery Recalls Manju Blackbeans for Undeclared Allergens

    Regalo Bakery is recalling Manju Blackbeans (Hopia Monggo) because the product contains undeclared eggs, wheat, soy, and artificial food coloring.

    Product
    Regalo Bakery: "Manju Blackbeans (Hopia Monggo)" [UPC#78253230917] packaged on a foam tray with six pieces each, wrapped in clear plastic film. This product contains: eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0251-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Egg Salad Due to Listeria Risk

    SM Fish Corp. is recalling 225 units of Ossie's Egg Salad in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S EGG SALAD, NET WT. 7 OZ., UPC 73988570552; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0115-2017·2016-11-02

    St Jude Medical Recalls Implantable Cardiac Defibrillators Due to Battery Defect

    St Jude Medical is recalling specific implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because a lithium cluster in the battery can cause a short circuit and premature battery depletion.

    Product
    Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR, Model No. CD2231-40…
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2016.