The Recall Desk

Archive

June 2015 recalls

481 recalls were announced in June 2015.

What the numbers show

Critical
29
Severe
127
High
231
Moderate
74
Low
20

Of the 481 recalls this month scored against our rubric, 6% are Critical, 26% are Severe.

101–200 of 481

  • SevereFDA (Food)·F-2413-2015·2015-06-17

    FDA Recalls Kr8om Max Kratom Capsules Due to Kratom Content

    Nuevotanicals is recalling Kr8om Max3 and Kr8om Max10 capsules because they contain Kratom. The products were distributed in 12 states.

    Product
    Kr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 3 capsules; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 10 capsules; Capsules are packed in a round, clea
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-2436-2015·2015-06-17

    AYAA Corn Cake Recalled for Undeclared Milk Allergen

    AYAA Popcorn Manufacturing Corp. is recalling Corn Cake 10 oz and 14 oz packages because FDA inspection found undeclared milk on the labels.

    Product
    Corn Cake 10 oz and 14 oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1127-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility.

    Product
    Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1733-2015·2015-06-17

    Roche Recalls Accu-Chek Spirit Combo Insulin Pumps Due to Mechanical Errors

    Roche is recalling Accu-Chek Spirit Combo insulin pumps because mechanical errors may stop insulin delivery, potentially leading to severe hyperglycemia.

    Product
    AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2410-2015·2015-06-17

    Nuevotanicals Recalls Kratom Alkaloid Suspension Oil Products

    Nuevotanicals is recalling Kratom alkaloid suspension oil products because they contain Kratom.

    Product
    Kratom (Kr8om) Premium Bali Alkaloid Suspension Oil in 135 mg., 200 mg., and 300 mg. dosages and Kratom (KR8om) Bali Custom Alkaloid Suspension Oil in 175 mg dosage
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Devices)·Z-1716-2015·2015-06-17

    Fresenius CRIT-LINE Blood Chamber Recalled for Connection Leaks

    Fresenius Medical Care is recalling CRIT-LINE Blood Chambers because the connection may leak during use.

    Product
    CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1779-2015·2015-06-17

    Philips Precedence 6 UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling Precedence 6 UPS accessory devices for CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V385000·2015-06-17

    Land Rover Recalls Range Rover Models for Door Latch Defect

    Jaguar Land Rover is recalling 2013-2016 Range Rover and 2014-2016 Range Rover Sport vehicles because doors may unlatch unexpectedly, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1736-2015·2015-06-17

    Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

    Smith & Nephew is recalling R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.

    Product
    R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1734-2015·2015-06-17

    Roche Recalls Accu-Chek Spirit Insulin Pumps Due to Mechanical Errors

    Roche Diabetes Care is recalling Accu-Chek Spirit insulin pumps because mechanical errors may stop insulin delivery, potentially leading to severe hyperglycemia.

    Product
    AccuChek Spirit insulin infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1767-2015·2015-06-17

    Philips Medical Systems Recalls Extended Brilliance Workstation UPS Accessories

    Philips Medical Systems is recalling Extended Brilliance Workstation UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1781-2015·2015-06-17

    Philips Gemini GXL 16 Slice CT Systems Recalled for UPS Battery Hazards

    Philips is recalling 15 Gemini GXL 16 Slice CT systems worldwide because their UPS accessory devices may leak battery acid, overheat, or emit fumes.

    Product
    Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1125-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility.

    Product
    Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1770-2015·2015-06-17

    Philips Ingenuity Flex UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling 23 Ingenuity Flex UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1750-2015·2015-06-17

    ResMed Astral Ventilator Recall Due to Alarm Disabling Hazard

    ResMed is recalling Astral 100 and 150 ventilators because clinicians can disable all alarms, including circuit disconnection alerts, posing a risk of insufficient ventilation.

    Product
    Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1117-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling Alprostadil injectable vials because objectionable conditions were observed during an FDA inspection, raising concerns about sterility.

    Product
    Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1130-2015·2015-06-17

    Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities

    Akorn, Inc. is recalling Hydroxyzine Hydrochloride oral solution because it failed impurities and degradation specifications. The product was distributed nationwide, including Puerto Rico.

    Product
    Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1738-2015·2015-06-17

    Smith & Nephew R3 Constrained Liner Recalled for Locking Groove Defect

    Smith & Nephew is recalling 40 units of R3 Constrained Liners because the locking groove is oversized, preventing the locking ring from engaging properly.

    Product
    R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1118-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling Alprostadil injectable vials due to lack of assurance of sterility and objectionable conditions observed during an FDA inspection.

    Product
    Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1122-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Glutathione Nasal Solution Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Glutathione Nasal Solution because FDA inspectors observed objectionable conditions that raise concerns about the product's sterility.

    Product
    Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1131-2015·2015-06-17

    Baxter Recalls Subpotent Heparin Sodium Injection Due to Raw Material Issues

    Baxter Healthcare is recalling specific lots of Heparin Sodium in Sodium Chloride Injection because the raw material was found to be subpotent and out of specification.

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1120-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Bimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling Bimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility assurance.

    Product
    Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1121-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Glutathione Inhalation Solution Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling 20 vials of Glutathione Inhalation solution because objectionable conditions were observed during an FDA inspection, raising concerns about sterility.

    Product
    Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1126-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials due to lack of assurance of sterility observed during an FDA inspection.

    Product
    Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-2412-2015·2015-06-17

    Nuevotanicals Recalls Greenjoy Herbal Mind & Body Shot for Kratom Content

    Nuevotanicals is recalling Greenjoy Herbal Mind & Body Shots because the product contains Kratom. The recall covers products distributed in twelve states.

    Product
    100% NATURAL HERBAL MIND & BODY SHOT greenjoy Sustained, Relaxed Energy Supports Mood & Immune Functions Relief of pain for aging bodies HERBAL SUPPLEMENT 2.0 fl oz (59 mL) Formulated + MfG'd by NUEVOtanicals, LLC Fort Worth, Texas 76112 Distributed by: Scientific Bota
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-1119-2015·2015-06-17

    Montana Compounding Pharmacy Recalls Avastin Syringes Due to Sterility Concerns

    Montana Compounding Pharmacy is recalling Avastin syringes because FDA inspectors observed objectionable conditions that raise concerns about sterility.

    Product
    Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-2435-2015·2015-06-17

    AYAA Cheese and Guava Cake Recalled for Undeclared Milk

    AYAA Popcorn Manufacturing Corp. is recalling 180 units of Cheese / Guava Cake 2 oz due to undeclared milk found during an FDA inspection.

    Product
    Cheese / Guava Cake 2 oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1783-2015·2015-06-17

    Philips TruFlight Select PET/CT Uninterruptible Power Supply Recall

    Philips is recalling 31 TruFlight Select PET/CT systems because the Uninterruptible Power Supply (UPS) accessory devices may leak battery acid, overheat, or emit fumes.

    Product
    TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2395-2015·2015-06-17

    Reaction Nutrition Recalls Amino Action Supplement Due to Undeclared Whey

    Reaction Nutrition is recalling Amino Action supplements because they may contain undeclared whey protein, posing a risk to individuals with milk allergies.

    Product
    REACTION RECOR: Amino Action- 500g (Cherry Lime), Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2015·2015-06-17

    Elekta Recalls Leksell GammaPlan Software Due to Memory Corruption

    Elekta is recalling 10 units of Leksell GammaPlan 10.2 software because memory can become corrupted when creating a fused study via drag and drop.

    Product
    Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1761-2015·2015-06-17

    Philips Recalls CT Scanner UPS Accessories Due to Battery Acid Leakage Risk

    Philips Medical Systems is recalling 788 Uninterruptible Power Supply (UPS) accessories for CT scanners due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2015·2015-06-17

    Ortho-Clinical VITROS 5600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.

    Product
    VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1765-2015·2015-06-17

    Philips CT Scanner UPS Accessory Recall for Battery Acid Leakage

    Philips Medical Systems is recalling 847 UPS accessory devices for CT scanners due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2015·2015-06-17

    Philips Recalls GEMINI TF Ready UPS Accessory Devices for CT Systems

    Philips Medical Systems is recalling three GEMINI TF Ready UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fumes.

    Product
    GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2015·2015-06-17

    Smiths Medical Recalls Low Volume Extension Sets Due to Tubing Defect

    Smiths Medical is recalling 6,000 units of Low Volume Extension Sets because under-sized tubing was used in production. The affected product was distributed to five states.

    Product
    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1766-2015·2015-06-17

    Philips CT Scanner UPS Accessory Recall for Battery Acid Leakage

    Philips is recalling 25 Brilliance CT 6 Slice Air UPS accessories due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2015·2015-06-17

    Philips Medical Systems Recalls Ingenuity Core 128 UPS Accessory Devices

    Philips Medical Systems is recalling 288 Ingenuity Core 128 UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2015·2015-06-17

    Philips Recalls Brilliance CT 40 Uninterruptible Power Supply Accessory Devices

    Philips Medical Systems is recalling 17 Brilliance CT 40 Uninterruptible Power Supply (UPS) accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2015·2015-06-17

    Philips Precedence 16 UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling 36 Precedence 16 UPS accessory devices used in CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2015·2015-06-17

    Vilex FUZE Ankle Arthrodesis Screws Recalled for Breakage

    Vilex, Inc. is recalling 4 units of FUZE 10.0 mm x 250 mm ankle arthrodesis screws due to a higher-than-expected incidence of breakage.

    Product
    Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1789-2015·2015-06-17

    Philips Recalls GEMINI TF Big Bore UPS Accessory Devices for Leakage Risk

    Philips Medical Systems is recalling 39 GEMINI TF Big Bore UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1758-2015·2015-06-17

    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled for Potential Damage

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to potential damage near the hub that may cause blood leakage.

    Product
    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2015·2015-06-17

    Philips Recalls GEMINI TF PET/CT 16 Slice UPS Accessory Devices

    Philips is recalling 69 GEMINI TF PET/CT 16 Slice systems due to UPS accessory devices that may leak battery acid, overheat, or emit fumes.

    Product
    GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1791-2015·2015-06-17

    Philips Recalls BrightView SPECT UPS Accessory Devices for Safety Hazards

    Philips Medical Systems is recalling 277 BrightView SPECT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2015·2015-06-17

    HeartWare HVAD Recall Issued for Discolored and Cracked Driveline Outer Sheath

    HeartWare Inc is recalling HVAD systems due to complaints of discolored and cracked driveline outer sheaths. The recall affects 3,747 units currently in use.

    Product
    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1775-2015·2015-06-17

    Philips Medical Systems Recalls AXIS UPS Accessory Devices for CT Systems

    Philips Medical Systems is recalling AXIS Uninterruptible Power Supply (UPS) accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2391-2015·2015-06-17

    Reaction Nutrition Recalls Bio Armor CreaMatrix for Undeclared Allergens

    Reaction Nutrition is recalling Bio Armor CreaMatrix supplements because they may contain undeclared whey protein and soy.

    Product
    Bio Armor CreaMatrix 306g 60 servings Unflavored, Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2015·2015-06-17

    CooperSurgical Ally Uterine Positioning System Recalled for Injury Risk

    CooperSurgical is recalling five Ally Uterine Positioning System units because the design may expose users to injury to fingers or body parts.

    Product
    Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1769-2015·2015-06-17

    Philips iCT SP UPS Accessory Devices Recalled for Battery Acid Leakage Risk

    Philips Medical Systems is recalling 110 iCT SP UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2399-2015·2015-06-17

    Reaction Nutrition Recalls Pre-Workout Supplements Due to Undeclared Allergens

    Reaction Nutrition is recalling REACTION RECOR: Pre Action supplements because they may contain undeclared whey protein and soy.

    Product
    REACTION RECOR: Pre Action- 336g Orange Xplosion, Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2407-2015·2015-06-17

    Evolution Fresh Yogurt Recalled for Undeclared Almonds

    Flying Food Group is recalling Evolution Fresh brand Greek yogurt with berries and honey due to undeclared almonds. The product was distributed to stores in California.

    Product
    evolution FRESH brand Fresh Berries & Honey, Nonfat Greek Yogurt with Strawberries, Blueberries, Pure Honey, & Granola; NET WT 6.5 OZ/184 g; Perishable Keep Refrigerated; SKU 11048364; Made Exclusively For: Evolution Fresh, Inc. 2401 Utah Avenue South Seattle, WA 98134 US
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2398-2015·2015-06-17

    Reaction Nutrition Recalls Creatine Supplements for Potential Allergen Contamination

    Reaction Nutrition is recalling specific lots of RN BlueChip Creatine Monohydrate because shared equipment use may result in undeclared whey protein and soy.

    Product
    RN BlueChip: Creatine, Creatine Monohydrate, 400 grams, Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2015·2015-06-17

    HeartWare Ventricular Assist System Recalled for Damaged Power Supply Pins

    HeartWare Inc is recalling HVAD systems due to complaints of damaged or bent connection pins in the power supply ports of the VAD controller.

    Product
    HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1763-2015·2015-06-17

    Philips Brilliance CT 40 Uninterruptible Power Supply Recall

    Philips is recalling Brilliance CT 40 Uninterruptible Power Supply accessories due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2015·2015-06-17

    Philips Recalls CT Scanner UPS Accessories Due to Battery Acid Leakage Risk

    Philips Medical Systems is recalling 126 UPS accessory devices for CT scanners due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2015·2015-06-17

    Ortho-Clinical enGen Laboratory Automation System Recalled for Sample Handling Defects

    Ortho-Clinical Diagnostics is recalling 45 enGen Laboratory Automation Systems worldwide because recapper caps may fall off or tubes may be dropped, risking bio-hazardous fluid splashing and cross-contamination.

    Product
    enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2389-2015·2015-06-17

    Reaction Nutrition Recalls Bio Armor Carno Pump Plus Due to Allergen Cross-Contact

    Reaction Nutrition is recalling Bio Armor Carno Pump Plus Electrolytes because shared equipment may cause cross-contact with whey protein and soy.

    Product
    Bio Armor Carno Pump Plus Electrolytes 40 servings (Blue Raspberry), Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2397-2015·2015-06-17

    Reaction Nutrition Recalls L-Glutamine Powder for Potential Allergen Contamination

    Reaction Nutrition is recalling L-Glutamine Powder because it may contain undeclared whey protein and soy due to shared equipment use.

    Product
    RN BlueChip: Glutamine, L-Glutamine Powder, 400 grams, Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2418-2015·2015-06-17

    Natural Creations Recalls New Zealand Colostrum Supplement Due to Milk Allergen

    Natural Creations is voluntarily recalling 399 bottles of New Zealand Colostrum dietary supplement because it contains an unidentified milk allergen.

    Product
    250cc White Plastic Container containing 120 capsules, labeled Natural Creations New Zealand Colostrum, Colostrum Supplement, MFG. FOR: Natural Creations, Woodbine, IA 51579, 712-647-1600
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1759-2015·2015-06-17

    Philips Medical Systems Recalls MX 16 Slice UPS Accessory Devices

    Philips Medical Systems is recalling 125 MX 16 Slice UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2392-2015·2015-06-17

    Reaction Nutrition Recalls Bio Armor CreaMatrix for Undeclared Allergens

    Reaction Nutrition is recalling Bio Armor CreaMatrix supplements because they may contain undeclared whey protein and soy due to shared equipment use.

    Product
    Bio Armor CreaMatrix 60 servings Blue Raspberry, Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2396-2015·2015-06-17

    Reaction Nutrition Recalls Amino Action Supplements Due to Undeclared Whey

    Reaction Nutrition is recalling Amino Action supplements because they may contain undeclared whey protein due to shared equipment use.

    Product
    REACTION RECOR: Amino Action- 500g (Glacier Blue), Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2015·2015-06-17

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry System software due to a defect that allows improper sample metering for urine assays requiring acidification.

    Product
    VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2015·2015-06-17

    Zimmer Recalls M/L Taper Hip Stems Due to Cytotoxicity Levels

    Zimmer is voluntarily recalling 752 M/L Taper hip implants because they contain higher than allowed cytotoxicity levels, posing a risk of adverse biological response.

    Product
    M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, pol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2015·2015-06-17

    Philips Medical Systems Recalls Forte-JetStream AZ UPS Accessory Devices

    Philips Medical Systems is recalling 11 Forte-JetStream AZ UPS accessory devices used in CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fumes.

    Product
    Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2015·2015-06-17

    Remel Blood Agar Plates Recalled for Listeria monocytogenes Contamination

    Remel Inc is recalling specific lots of Blood Agar plates due to potential Listeria monocytogenes contamination. The products were distributed nationwide.

    Product
    Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2015·2015-06-17

    Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

    Smith & Nephew is recalling 32 units of R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.

    Product
    R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1790-2015·2015-06-17

    Philips BrightView X UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling 108 BrightView X UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner for Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, allowing the cleaning cycle to complete without proper processing.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1784-2015·2015-06-17

    Philips CardioMD III UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling 81 CardioMD III UPS accessory devices for CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1792-2015·2015-06-17

    Philips Recalls BrightView XCT UPS Accessory Devices for Battery Acid Leakage

    Philips Medical Systems is recalling 337 BrightView XCT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2015·2015-06-17

    Philips Recalls Gemini 16 PET/CT Uninterruptible Power Supply Accessories

    Philips is recalling 7 Gemini 16 PET/CT Uninterruptible Power Supply units worldwide due to risks of battery acid leakage, overheating, and fumes.

    Product
    Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2015·2015-06-17

    Gyrus ACMI Diego Elite Tubeset Recalled for Sterility Assurance Concerns

    Gyrus Acmi is recalling Diego Elite Tubesets due to a potential lack of sterility assurance. The recall affects 12,020 boxes distributed in the US, Canada, and other countries.

    Product
    Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2015·2015-06-17

    Ortho-Clinical VITROS 4600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System software versions 3.2 and below due to a defect that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.

    Product
    VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2015·2015-06-17

    Philips Medical Systems Recalls Ingenuity Core UPS Accessory Devices

    Philips Medical Systems is recalling 215 Ingenuity Core UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1773-2015·2015-06-17

    Philips Ingenuity CT Uninterruptible Power Supply Recall for Battery Acid Leakage

    Philips is recalling 156 Ingenuity CT Uninterruptible Power Supply (UPS) accessory devices due to a risk of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2015·2015-06-17

    Smith & Nephew R3 Constrained Liner Recalled for Sizing Defect

    Smith & Nephew is recalling 12 units of R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.

    Product
    R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner Due to Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, potentially allowing incomplete disinfection cycles.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2015·2015-06-17

    Philips FORTE UPS Accessory Devices Recalled for Battery Acid Leakage Risk

    Philips Medical Systems is recalling 10 FORTE Uninterruptible Power Supply (UPS) accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2015·2015-06-17

    Philips Brilliance iCT UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling Brilliance iCT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2015·2015-06-17

    Gyrus ACMI Diego Elite Tubeset Recalled for Sterility Assurance Concerns

    Gyrus Acmi is recalling 22,250 boxes of Diego Elite Tubesets due to a potential lack of sterility assurance. The devices are used for ENT and head and neck procedures.

    Product
    Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2015·2015-06-17

    Philips Recalls Ingenuity PET/MR Uninterruptible Power Supply Accessory Devices

    Philips Medical Systems is recalling nine Ingenuity PET/MR Uninterruptible Power Supply (UPS) accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1782-2015·2015-06-17

    Philips Gemini LXL 16 Slice CT Systems Recalled for UPS Defects

    Philips is recalling 10 Gemini LXL 16 Slice CT systems worldwide due to UPS accessory defects that may cause battery acid leakage, overheating, or fumes.

    Product
    Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2414-2015·2015-06-17

    FDA Recalls Kr8om Max Kratom Tablets Due to Kratom Content

    Nuevotanicals is recalling Kr8om Max2, Max5, and Max10 tablets because they contain Kratom. The products were distributed in 12 states.

    Product
    Kr8om Max2 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 2 tablets; Kr8om Max5 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 5 tablets; Kr8om Max10 All-Natural Extraction, Form
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1747-2015·2015-06-17

    Becton Dickinson Recalls BBL Port A Cul Tubes Due to Oxidation

    Becton Dickinson is recalling BBL Port A Cul tubes with Swabs Sterile Pack because excessive oxidation may affect the viability of anaerobic microorganisms.

    Product
    BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2015·2015-06-17

    Philips Recalls GEMINI TF PET/CT 64 Slice UPS Accessory Devices

    Philips Medical Systems is recalling 71 GEMINI TF PET/CT 64 Slice UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2015·2015-06-17

    Biomet Recalls Unilateral External Fixation Ankle Clamps Due to Assembly Error

    Biomet, Inc. is recalling 19 unilateral external fixation ankle clamps because they were assembled incorrectly. The defect may prevent full range of motion and cause the pin to loosen from the bone.

    Product
    Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2015·2015-06-17

    Philips MX 16 Slice Phase II CT Systems Recalled for UPS Battery Hazards

    Philips is recalling 11 MX 16 Slice Phase II CT systems because their UPS accessory devices may leak battery acid, overheat, or emit fumes.

    Product
    MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2428-2015·2015-06-17

    Golden Krust Recalls Shrimp and Soya Patties Due to Undeclared Egg

    Golden Krust Caribbean Bakery is recalling Jamaican Style Shrimp & Soya Patties because they contain undeclared egg.

    Product
    Golden Krust SOYA PATTIES, NET WT. 17.2 LBS, 50 UNBAKED, KEEP FROZEN
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-2401-2015·2015-06-17

    Reaction Nutrition Recalls Amino Action Supplements Due to Undeclared Whey Protein

    Reaction Nutrition is recalling Amino Action supplements because they may contain undeclared whey protein due to shared equipment use.

    Product
    REACTION RECOR: Amino Action- 500g (Island Breeze), Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2429-2015·2015-06-17

    Golden Krust Caribbean Shrimp Patties Recalled for Undeclared Egg

    Golden Krust Caribbean Bakery is recalling Jamaican Style Shrimp Patties due to the presence of undeclared egg.

    Product
    Golden Krust Caribbean JAMAICAN STYLE SHRIMP PATTIES, NET WT. 17.2 LBS, 50 UNBAKED, KEEP FROZEN
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-2390-2015·2015-06-17

    Reaction Nutrition Recalls Bio Armor Carno Pump Plus Electrolytes

    Reaction Nutrition is recalling Bio Armor Carno Pump Plus Electrolytes because shared equipment may cause unknown amounts of whey protein and soy contamination.

    Product
    Bio Armor Carno Pump Plus Electrolytes 40 servings (Cherry Lime), Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1793-2015·2015-06-17

    Philips CT Scanner UPS Accessory Recall for Battery Acid Leakage Risk

    Philips Medical Systems is recalling two Diamond Select Brilliance CT 16 systems due to a risk of battery acid leakage, overheating, and fumes from the UPS accessory.

    Product
    Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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