The Recall Desk

Archive

January 2014 recalls

1,423 recalls were announced in January 2014.

What the numbers show

Critical
161
Severe
415
High
291
Moderate
533
Low
23

Of the 1,423 recalls this month scored against our rubric, 11% are Critical, 29% are Severe.

Which agencies issued them

901–1000 of 1423

  • HighFDA (Devices)·Z-0641-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0639-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, compromising sterility and posing an injury risk.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0665-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adminis
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0662-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave¿, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1095 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0705-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Leakage Risk

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0633-2014·2014-01-15

    Welch Allyn Propaq LT Series Monitors Recalled for Potential Operational Interruption

    Welch Allyn is updating software on Propaq LT Series monitors because rare hardware or software faults could interrupt device operations.

    Product
    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2014·2014-01-15

    Siemens HB1C Flex Reagent Cartridges Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling HB1C Flex Reagent Cartridges due to positive bias and frequent 'Above Assay Range' flags.

    Product
    HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative dete
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave¿, Part No. A1000, Item No. A1078 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0645-2014·2014-01-15

    Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles

    Smiths Medical is recalling 108,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0635-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades

    Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2014·2014-01-15

    Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles

    Smiths Medical is recalling 54,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0653-2014·2014-01-15

    Alere Recalls Oral Fluid Drug Screen Devices Due to Choking Risk

    Alere is recalling specific lots of Oral Fluid Drug Screen Devices because the sponge may dislodge, creating a choking hazard.

    Product
    Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually po
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1379-2014·2014-01-15

    ANAT LLC Recalls IMT Wellness Legume Digest 2.0 Due to Chloramphenicol Risk

    ANAT, LLC is recalling IMT Wellness Legume Digest 2.0 dietary supplements due to potential chloramphenicol contamination. The product was distributed in Connecticut.

    Product
    IMT Wellness Legume Digest 2.0** Dietary Supplements 120 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT; in a white 150 cc bottle with white cap
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1385-2014·2014-01-15

    Armanino Alfredo Sauce Recalled for Missing Allergen Labeling

    Del Monaco Specialty Foods is recalling Armanino Alfredo Sauce because the cartons are missing the label containing ingredient and allergen information.

    Product
    Armanino Alfredo Sauce; Frozen in 10 oz x 12 pouches per case (sample, not for retail sale) and 3 lb. pouches 4 x 3 lb. pouches per case for food service use UPC - 10 oz. samples: 10041622 002635 UPC 3 lb. pouch: 10041622 019428 Distributed by Armanino Foods, Hayward, CA;
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1384-2014·2014-01-15

    Perrigo Recalls EstroPlus Menopause Supplements Due to Chloramphenicol Contamination

    Perrigo of SC is recalling EstroPlus Maximum Strength Menopause Support dietary supplements due to potential chloramphenicol contamination. The recall affects 68,534 units distributed in seven states.

    Product
    EstroPlus Maximum Strength Menopause Support Dietary Supplement in 28 count and 56 count blister strips under the following labels - CareOne Maximum Strength Multi Symptom Menopause Formula, 28 Caplets/Dietary Supplement; Meijer Maximum Strength Estroplus, Dietary Supplement, 28
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0678-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular a
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0647-2014·2014-01-15

    On Site Gas Systems POGS 33C Portable Oxygen System Recall

    On Site Gas Systems is recalling 198 POGS 33C portable oxygen generation systems in Pennsylvania because the heat exchanger hose may fail.

    Product
    On Site Gas Systems POGS 33C Portable Oxygen Generation System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0661-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave ¿, NanoClave¿ T-Connector, Rotating Luer, Part No. A1000, Item No. 011-A1094 The ICU Needleless Connector is a single use, sterile, non-pyro
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0637-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades

    Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the a
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0680-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0670-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave¿, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, 3 Ext, Part No. A1000, Item No. A1026 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0666-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.

    Product
    6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the admi
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0695-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0673-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flui
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0668-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.

    Product
    7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular adminis
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0699-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Leakage Risk

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accesso
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0706-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administrat
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0703-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flui
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0529-2014·2014-01-15

    EOS Imaging Recalls EOS System X-ray Digital Radiography Devices

    EOS Imaging is recalling 22 EOS System X-ray digital radiography units installed in the US due to a discrepancy between the operator-set collimation and the actual X-ray beam collimation.

    Product
    EOS System X- ray beam Digital radiography system used in general radiographic examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2014·2014-01-15

    GE Healthcare Recalls Patient Data Modules Due to Heat Buildup Risk

    GE Healthcare is recalling 17,444 Patient Data Modules used with SOLAR 8000 and Transport Pro monitors. The recall addresses a potential safety issue where fluid ingress can cause heat buildup.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2014·2014-01-15

    Optimedica Catalys Precision Laser System Recalled for Transformer Heating Risk

    Optimedica is recalling 78 Catalys Precision Laser Systems worldwide due to a risk of transformer heating and smoke.

    Product
    Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration s
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0642-2014·2014-01-15

    Smiths Medical Recalls Insulin Syringes Due to Visible Particulate on Needles

    Smiths Medical is recalling specific lots of Hypodermic Needle-Pro Fixed Needle Insulin Syringes because visible orange or brown particulate was found on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0671-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adminis
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0676-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the admin
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0669-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron Filter, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intrav
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0623-2014·2014-01-15

    Aesculap Recalls Hi-Line XXS Handpieces Due to Possible Failure

    Aesculap, Inc. is recalling 14 Hi-Line XXS handpieces due to a possible failure of the device. The handpieces are used to hold burrs that cut and shape bone.

    Product
    Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0693-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.

    Product
    10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0663-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1097 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intend
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0704-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular adminis
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0707-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0657-2014·2014-01-15

    Anspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk

    The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems because the handpiece hose can rupture without warning if airflow is blocked.

    Product
    ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0532-2014·2014-01-15

    Trans American Medical Recalls Spectre Wireless Footswitches Due to Uncommanded X-ray Risk

    Trans American Medical is recalling 68 Spectre Wireless Footswitch/Handswitch units because they may produce uncommanded X-rays.

    Product
    Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0628-2014·2014-01-15

    Materialise Recalls Shipped Femur Guide Due to Fit Conformance Issue

    Materialise USA LLC is recalling a specific lot of shipped femur guides from the Signature Personalized Patient Care System because a non-conformance could impact the fit of the drill insert.

    Product
    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specifi
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0630-2014·2014-01-15

    Stryker Color Cuff Tourniquet Cuffs Recalled for Incorrect Connector

    Stryker is recalling specific Color Cuff tourniquets because they may have the wrong connector, which can make the system inoperable.

    Product
    Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0708-2014·2014-01-15

    Anspach Recalls Micro Curved Attachments Due to Unclear Directions for Use

    The Anspach Effort, Inc. is recalling MCA Micro Curved Attachments and cutting burrs because the directions for use do not clearly specify intended use for delicate bone in otologic procedures.

    Product
    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0622-2014·2014-01-15

    Integra Rickham Reservoirs Recalled for Bent or Broken Connectors

    Integra LifeSciences is recalling 78 packages of Rickham-Style Reservoirs due to bent or broken connectors found after opening sterile packages.

    Product
    Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining C
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Food)·F-1383-2014·2014-01-15

    Safeway Kitchens In Shell Edamame Recalled for Pesticide Residue

    Safeway Inc is recalling 22 cases of In Shell Edamame after FDA testing detected trace amounts of the pesticide chlorafluazuron.

    Product
    Safeway Kitchens In Shell Edamame; Net Wt: 48 oz. (3 lb, 1.35Kg) 12 x 3 lb bags per case: Product of China: Packed in Canada Safeway, Pleasanton, CA.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0627-2014·2014-01-15

    RTI Surgical Recalls C-Plus Implants Due to Labeling Documentation Error

    RTI Surgical is recalling 1,906 C-Plus 10mm x 12mm Webless implants because they were incorrectly documented as meeting labeling requirements for a partial Vertebral Body Replacement Device.

    Product
    C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-400-2014·2014-01-15

    Mutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error

    Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

    Product
    Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-398-2014·2014-01-15

    Mutual Pharmaceutical Recalls FIBRICOR Tablets Due to Labeling Error

    Mutual Pharmaceutical is recalling FIBRICOR (fenofibric acid) tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

    Product
    FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-399-2014·2014-01-15

    Mutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error

    Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

    Product
    Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·14079·2014-01-14

    SRAM Recalls Hydraulic Bicycle Brakes Due to Crash and Injury Hazards

    SRAM is recalling about 25,350 hydraulic road rim and disc brakes for bicycles because the systems can fail, posing a crash and injury hazard.

    Product
    SRAM Hydraulic Road Rim Brakes and Hydraulic Road Disc Brakes for bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14708·2014-01-14

    Arctic Cat Recalls 2014 Snowmobiles Due to Fuel Leak Fire Hazard

    Arctic Cat is recalling about 264 Model Year 2014 500 Sno Pro snowmobiles because fuel can leak from the tank, posing a fire hazard. No injuries have been reported.

    Product
    Arctic Cat snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V007000·2014-01-13

    General Motors Recalls 2014-2015 Trucks and SUVs for Engine Fire Risk

    General Motors is recalling specific 2014-2015 Chevrolet, GMC, and Cadillac vehicles because overheated exhaust components may melt plastic parts and cause an engine fire.

    Product
    CHEVROLET — CHEVROLET, GMC, CADILLAC SILVERADO, SIERRA 1500, ESCALADE, YUKON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·001-2014·2014-01-10

    Tyson Recalls Mechanically Separated Chicken Due To Salmonella Heidelberg Contamination

    Tyson Foods is recalling 33,840 pounds of mechanically separated chicken products due to possible Salmonella Heidelberg contamination linked to a cluster of illnesses.

    Product
    Tyson Foods, Inc. — Missouri Firm Recalls Mechanically Separated Chicken Products Due To Possible Salmonella Heidelberg Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·14076·2014-01-09

    U.S. Boiler Recalls Gas-Fired Hot Water Boilers Due to Carbon Monoxide Hazard

    U.S. Boiler is recalling approximately 26,000 gas-fired hot water boilers in the U.S. and 310 in Canada because a faulty air pressure switch may allow excessive carbon monoxide emissions.

    Product
    Gas-fired hot water boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14077·2014-01-09

    New Yorker Boiler Recalls Gas-Fired Hot Water Boilers Due to Carbon Monoxide Hazard

    New Yorker Boiler Company is recalling about 191 gas-fired hot water boilers manufactured between May 2012 and February 2013 because a defective air pressure switch can allow excessive carbon monoxide emissions.

    Product
    Gas-fired hot water boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1335-2014·2014-01-08

    Reser's Cheesy Macaroni Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Cheesy Macaroni Salad due to potential Listeria monocytogenes contamination. The product was distributed only in Canada.

    Product
    Reser's Fine Foods, Cheesy Macaroni Salad, packaged in 454 gm (UPC 071117182415) and 1.25 KG (UPC 071117612271) plastic containers.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1284-2014·2014-01-08

    Mira Health Products Recalls Nature Science Methadrol Capsules

    Mira Health Products Ltd. is recalling Nature Science Methadrol capsules due to potential contamination with undeclared steroids and chemical additives.

    Product
    Nature Science Methadrol capsules packaged in a plastic bottle with 60 capsules per bottle.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0596-2014·2014-01-08

    Asante Comfort Infusion Set Recalled for Tubing Disconnection

    Asante Solutions is recalling 635 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1291-2014·2014-01-08

    Mira Health Recalls B-50 Dietary Supplement for Potential Steroid Contamination

    Mira Health Products Ltd. is recalling B-50 dietary supplements due to potential contamination with undeclared steroids, pharmaceutical ingredients, or chemical additives resulting from a lack of Good Manufacturing Practices.

    Product
    B-50, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale,
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1300-2014·2014-01-08

    Park Labs Reparagen + Glucosamine Recalled for Potential Steroid Contamination

    Mira Health Products is recalling Park Labs Reparagen + Glucosamine capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    Park Labs Reparagen + Glucosamine capsules packaged in a plastic bottle with 60 capsules per bottle.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0598-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.

    Product
    Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1361-2014·2014-01-08

    T & S Oyster Farm Recalls Smoked Oysters for Botulism Risk

    T & S Oyster Farm is recalling refrigerated hot smoked oysters due to potential contamination with Clostridium botulinum.

    Product
    The refrigerated vacuum packed hot smoked oysters, Habanero flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP R
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1328-2014·2014-01-08

    Biogenix USA Prematif Male capsules recalled for potential undeclared steroids

    Mira Health Products Ltd. is recalling Biogenix USA Prematif Male capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    Biogenix USA Prematif Male capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1320-2014·2014-01-08

    Mira Health Products Recalls Biogenix USA Halostane Capsules

    Mira Health Products Ltd. is recalling Biogenix USA Halostane capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    Biogenix USA Halostane capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1282-2014·2014-01-08

    Mira Health Recalls Nature Science 1 Andro Capsules Due to Steroid Contamination Risk

    Mira Health Products Ltd. is recalling Nature Science 1 Andro capsules because they may contain undeclared steroids or chemical additives due to poor manufacturing practices.

    Product
    Nature Science 1 Andro capsules packaged in a plastic bottle with 60 capsules per bottle.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1307-2014·2014-01-08

    Biogenix USA Super DMZ Capsules Recalled for Potential Steroid Contamination

    Mira Health Products Ltd. is recalling Biogenix USA Super DMZ capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    Biogenix USA Super DMZ capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1325-2014·2014-01-08

    Biogenix USA Male Pill capsules recalled for potential steroid contamination

    Mira Health Products Ltd. is recalling Biogenix USA Male Pill capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    Biogenix USA Male Pill capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1286-2014·2014-01-08

    Mira Health Recalls L-Glutamine Capsules Due to Potential Steroid Contamination

    Mira Health Products Ltd. is recalling L-Glutamine capsules labeled as Healthy Life Chemistry due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    L-Glutamine capsules, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Stre
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1299-2014·2014-01-08

    Park Labs Reparagen EX Recalled for Potential Steroid Contamination

    Mira Health Products Ltd. is recalling Park Labs Reparagen EX capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    Park Labs Reparagen EX capsules packaged in a plastic bottle with 60 capsules per bottle.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1360-2014·2014-01-08

    T&S Oyster Farm Recalls Smoked Oysters Due to Botulism Risk

    T&S Oyster Farm is recalling refrigerated vacuum-packed hot smoked oysters in Teriyaki flavor due to potential contamination with Clostridium botulinum.

    Product
    The refrigerated vacuum packed hot smoked oysters, Teriyaki flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP R
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1333-2014·2014-01-08

    Mira Health Products Recalls Biogenix USA Methadrol Capsules

    Mira Health Products is recalling Biogenix USA Methadrol capsules due to potential contamination with undeclared steroids and chemical additives.

    Product
    Biogenix USA Methadrol capsules, packaged in plastic bottles with 60 capsules per bottle.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0603-2014·2014-01-08

    Terumo Cardiovascular Procedure Kits Recalled Due to Uncleared Safety Valve

    Terumo is recalling 24,227 Custom Cardiovascular Procedure Kits because the Overpressure Safety Valve used in the arterial line was not cleared for that specific use.

    Product
    Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V004000·2014-01-08

    Glaval Bus Recalls 2010-2013 Models Due to Alternator Harness Pinch Risk

    Glaval Bus is recalling 467 model year 2010-2013 transit buses because a pinched alternator harness may cause vehicle stalling or fire.

    Product
    GLAVAL BUS — GLAVAL BUS, GLAVAL ENTOURAGE, TITAN II, UNIVERSAL, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1269-2014·2014-01-08

    Mira Health Recalls Nature Science Decadrol Capsules for Potential Steroid Contamination

    Mira Health Products Ltd. is recalling Nature Science Decadrol capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    Nature Science Decadrol capsules packed in plastic bottles with 90 capsules per bottle and packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1359-2014·2014-01-08

    T&S Oyster Farm Recalls Smoked Oysters Due to Botulism Risk

    T&S Oyster Farm is recalling Garlic Pepper smoked oysters due to potential Clostridium botulinum contamination. Consumers in Oregon should discard the product.

    Product
    The refrigerated vacuum packed hot smoked oysters, Garlic Pepper flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE K
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1266-2014·2014-01-08

    Mira Health Products Recalls Nature Science Bolasterol Capsules

    Mira Health Products Ltd. is recalling Nature Science Bolasterol capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    Nature Science Bolasterol capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1311-2014·2014-01-08

    Mira Health Recalls Biogenix USA M1 Capsules Due to Potential Contamination

    Mira Health Products Ltd. is recalling Biogenix USA M1 capsules because they may contain undeclared steroids or chemical additives due to a lack of Good Manufacturing Practices.

    Product
    Biogenix USA M1 capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1358-2014·2014-01-08

    T & S Oyster Farm Recalls Smoked Oysters Due to Botulism Risk

    T & S Oyster Farm is recalling refrigerated vacuum-packed hot smoked oysters due to potential contamination with Clostridium botulinum.

    Product
    The refrigerated vacuum packed hot smoked oysters, Original flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP R
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1296-2014·2014-01-08

    Mira Health Products Recalls Nisha Libigrow Capsules Due to Contamination Risk

    Mira Health Products Ltd. is recalling Nisha Libigrow capsules because they may contain undeclared steroids or chemical additives due to poor manufacturing practices.

    Product
    Nisha Libigrow capsules packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states

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