The Recall Desk

Archive

September 2015 recalls

1,186 recalls were announced in September 2015.

What the numbers show

Critical
119
Severe
561
High
378
Moderate
103
Low
25

Of the 1,186 recalls this month scored against our rubric, 10% are Critical, 47% are Severe.

Which agencies issued them

1–100 of 1186

  • CriticalFDA (Drugs)·D-1823-2015·2015-09-30

    PharMEDium Recalls Bupivacaine Bags Due to Human Hair Particulate Matter

    PharMEDium Services is recalling 20 bags of Bupivacaine HCl 0.0625% for epidural use because they contain human hair particulate matter.

    Product
    Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3244-2015·2015-09-30

    Fresh Origins Microgreens Celery Recalled for Salmonella Contamination

    Hardies Fruit & Vegetable Co. is recalling Fresh Origins Microgreens Celery because testing confirmed the presence of Salmonella.

    Product
    FRESH ORIGINS Microgreens Celery NET WT 4 OZ San Marcos, CA 92069 packed in clear plastic clam shell.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1816-2015·2015-09-30

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 139,104 bags of 0.9% Sodium Chloride Injection due to a reported complaint of mold on the interior surface of the overpouch.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2799-2015·2015-09-30

    Regard Custom Surgical Pack Recalled for Chemical Contamination and Sterility Issues

    Resource Optimization & Innovation Llc is recalling 67 Regard Custom Surgical Packs due to potential chemical contamination and lack of sterility assurance.

    Product
    Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1822-2015·2015-09-30

    Pharmedium Recalls Phenylephrine Injection Due to Human Hair Particulate Matter

    Pharmedium Services is recalling specific lots of Phenylephrine HCl injection due to the presence of human hair particulate matter.

    Product
    PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V610000·2015-09-30

    Keystone Recalls 2016 Retreat and Residence Trailers for Weld Defect

    Keystone RV Company is recalling 2016 Retreat and Residence recreational trailers due to a potential insufficient weld on the rear mounting plate, which could increase crash risk.

    Product
    KEYSTONE — KEYSTONE RETREAT, RESIDENCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1827-2015·2015-09-30

    Pharmedium Phenylephrine Injection Recalled for Particulate Matter

    Pharmedium Services, LLC is recalling 48 bags of Phenylephrine HCl injection due to the presence of particulate matter, specifically human hair, in the product.

    Product
    PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3245-2015·2015-09-30

    Majopa Graviola Extract Recalled for Unapproved Drug Claims

    Majopa Industries is recalling 500 bottles of Graviola Extract sold in Puerto Rico because the label made unapproved drug claims, including cancer treatment.

    Product
    Label reads in part as: "GRAVIOLA EXTRACT***1 FL Oz (30 ml)*** ORIGINAL FORMULA***Manufactured by: Majopa Industries Corp.*** PRODUCT OF PUERTO RICO,USA". Drug claims in the product label are as follows: "Researchers have found that Extracts from Graviola leaves can produce ac
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-3237-2015·2015-09-30

    Sam Mills Gluten Free Granola Bars Recalled for Undeclared Milk

    Sam MillsUSA LLC is recalling specific lots of Gluten Free Chocolate Chip Granola Bars because they contain undeclared milk, a major food allergen.

    Product
    Sam Mills Gluten Free Chocolate Chip Granola Bars with Dark Chocolate 5 bars/4.4oz Box (0.88oz each bar)
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1821-2015·2015-09-30

    Pharmedium Recalls Phenylephrine Injection Due to Human Hair Contamination

    Pharmedium Services, LLC is recalling specific lots of Phenylephrine HCl injection because the sodium chloride base used contained human hair.

    Product
    PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1824-2015·2015-09-30

    PharMEDium Recalls Morphine Sulfate IV Bags Due to Particulate Matter

    PharMEDium Services is recalling 100 bags of Morphine Sulfate IV solution because the sodium chloride used contained human hair.

    Product
    Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1826-2015·2015-09-30

    Pharmedium Recalls Phenylephrine Injection Due to Human Hair Particulate Matter

    Pharmedium Services is recalling 84 bags of Phenylephrine HCl injection because the sodium chloride base contained human hair.

    Product
    PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2788-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 30 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1825-2015·2015-09-30

    PharMEDium Recalls Fentanyl Citrate IV Bags Due to Particulate Matter

    PharMEDium Services, LLC is recalling 663 bags of Fentanyl Citrate IV solution because the sodium chloride used contained human hair.

    Product
    Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1828-2015·2015-09-30

    Pharmedium Recalls Phenylephrine Injection Bags Due to Particulate Matter

    Pharmedium Services is recalling 120 bags of Phenylephrine HCl injection due to the presence of human hair particulate matter.

    Product
    PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V613000·2015-09-30

    Daimler Recalls 2016 Freightliner Trucks Due to Steering Bolt Issue

    Daimler Trucks North America is recalling 10,843 model year 2016 Freightliner trucks because steering arm bolts may not be properly tightened, which could cause a loss of steering.

    Product
    FREIGHTLINER — FREIGHTLINER 114SD, 122SD, BUSINESS CLASS M2, COLUMBIA GLIDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2015·2015-09-30

    Regard Custom Surgical Pack Recalled Due to Chemical Contamination and Sterility Concerns

    Resource Optimization & Innovation Llc is recalling 24 Regard Custom Surgical Packs because they may contain chemically contaminated scrub products and lack sterility assurance.

    Product
    Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2790-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrator Component

    Terumo is recalling 15 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 High Performance Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the applicatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V614000·2015-09-30

    Ford Recalls 2015 F-150 Trucks for Adaptive Cruise Control Defect

    Ford is recalling 2015 F-150 trucks equipped with Adaptive Cruise Control because the system may falsely detect obstacles and brake unexpectedly, increasing crash risk.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2792-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 17 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the applicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2816-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 49 RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2015·2015-09-30

    Bien Air Dental Contra-Angles Recalled for Potential Tool Loosening

    Bien Air Dental SA is recalling specific EVO 15 contra-angles because the dental tool may loosen and be swallowed.

    Product
    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2786-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators

    Terumo is recalling 5 Custom Cardiovascular Procedure Kits because they contain recalled Medivators HPH700 Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2789-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators

    Terumo is recalling six custom cardiovascular procedure kits nationwide because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the applicatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2015·2015-09-30

    Edwards Lifesciences Recalls ThruPort Knot Pusher Due to Suture Fraying Risk

    Edwards Lifesciences is recalling 759 ThruPort Knot Pusher units because the device's tip design may cause suture fraying or splitting, potentially compromising suture knot integrity during cardiac surgery.

    Product
    ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1815-2015·2015-09-30

    Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter

    Hospira, Inc. is recalling Lidocaine Hydrochloride Injection vials because iron oxide particulate matter was found embedded in the glass vial necks.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3239-2015·2015-09-30

    Hillside Quickie Too Recalls Tofu Sandwiches Due to Undeclared Wheat

    Hillside Quickie Too is recalling New York Deli Tofu sandwiches in Washington because the product contains wheat but the label does not declare it.

    Product
    New York Deli Tofu is is tofu sandwich on bread or a bun, enclosed in a clam shell with label
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2793-2015·2015-09-30

    Ecolab Recalls Microtek ORS Fluid Warming and Slush Drapes Due to Seal Defects

    Ecolab is recalling Microtek ORS Fluid Warming and Slush Drapes because sterile packaging seals may contain small channels, potentially compromising package integrity and sterility.

    Product
    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-3241-2015·2015-09-30

    Hillside Quickie Too Recalls Jamaican Spice Tempeh Sandwiches for Allergen Mislabeling

    Hillside Quickie Too is recalling Jamaican Spice Tempeh sandwiches because the wheat bun was not listed in the 'Contains' allergen statement, posing a risk to consumers with wheat allergies.

    Product
    Jamaican Spice Tempeh is tofu sandwich on bread or a bun, enclosed in a clam shell with label
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2813-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2814-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 1,213 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2809-2015·2015-09-30

    Beckman Coulter MicroScan LabPro Software Recall for Manual Editing Error

    Beckman Coulter is recalling MicroScan LabPro software versions 1.0 to 4.11 because it incorrectly allows manual editing of carbohydrate substrates during specific manual readings.

    Product
    MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2812-2015·2015-09-30

    Siemens Medical Solutions Recalls Linear Accelerator Systems Due to Collision Risk

    Siemens Medical Solutions is recalling 26 linear accelerator systems and associated software because a defect could cause automatic movement, posing a collision risk to patients.

    Product
    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray phot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3243-2015·2015-09-30

    Hillside Quickie Too Tofustrami Recalled for Allergen Mislabeling

    Hillside Quickie Too is recalling Tofustrami sandwiches because the wheat bun ingredient was not listed in the allergen statement.

    Product
    Tofustrami is tofu sandwich on bread or a bun, enclosed in a clam shell with label
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-3242-2015·2015-09-30

    Hillside Quickie Too Recalls Seitan Steak Sandwiches for Allergen Mislabeling

    Hillside Quickie Too is recalling Seitan Steak sandwiches because the wheat bun was not listed in the 'Contains' statement, posing a risk to consumers with wheat allergies.

    Product
    Seitan Steak is tofu sandwich on bread or a bun, enclosed in a clam shell with label
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2795-2015·2015-09-30

    Brainlab Disposable Reflective Marker Spheres Recalled for Separation Risk

    Brainlab AG is recalling Disposable Reflective Marker Spheres because they may separate at the mid-point seal, posing a risk to patients during image-guided surgery.

    Product
    Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2791-2015·2015-09-30

    Terumo Cardiovascular Procedure Kits Recalled Due to Defective Hemoconcentrators

    Terumo is recalling 19 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the applicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2794-2015·2015-09-30

    Synthes Dynamic Locking Screw System Recalled for Pin Breakage

    Synthes (USA) Products LLC is recalling Dynamic Locking Screw Systems due to pin breakage during implant removal. This notice extends to additional consignees identified after a previous recall.

    Product
    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 32 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V611000·2015-09-30

    Ford Recalls 2016 F-53 and F-59 Trucks for Shift Cable Defect

    Ford is recalling 2016 F-53 and F-59 stripped chassis trucks because an incorrect shift cable bracket may allow the vehicle to shift out of park without brakes applied.

    Product
    FORD — FORD F-53, F-59
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2804-2015·2015-09-30

    Leica ASP6025 Tissue Processor Recalled for Incomplete Bottle Filling

    Leica Microsystems is recalling ASP6025 Tissue Processors because they may incorrectly detect empty bottles during filling, preventing the completion of a 5-liter fill.

    Product
    The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2805-2015·2015-09-30

    Fujifilm EPX 2500 Operation Manual Recalled for Incorrect Endoscope Specifications

    Fujifilm is recalling 60 EPX 2500 Operation Manuals and sales brochures that incorrectly identify the ED-530XT endoscope's image capabilities.

    Product
    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2796-2015·2015-09-30

    OrthoPediatrics Recalls 3.5mm Non Locking Cortical Screws Due to Packaging Error

    OrthoPediatrics Corp is recalling 3.5mm Non Locking Cortical Screws because the packaging may contain a different screw size than labeled.

    Product
    3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1817-2015·2015-09-30

    Allergan Recalls Refresh Lacri-Lube Eye Ointment Due to Particulate Matter

    Allergan is recalling Refresh Lacri-Lube eye ointment because unscrewing the cap may introduce small black particles into the product.

    Product
    REFRESH LACRI-LUBE — REFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1819-2015·2015-09-30

    Allergan Recalls FML Ophthalmic Ointment Due to Particulate Matter

    Allergan is recalling specific lots of FML ophthalmic ointment because small black particles from the tube cap may be present in the product.

    Product
    FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1818-2015·2015-09-30

    Allergan Recalls Refresh P.M. Eye Ointment Due to Particulate Matter

    Allergan is recalling Refresh P.M. eye ointment because small black particles from the tube cap may have entered the product.

    Product
    REFRESH P.M. — REFRESH P.M. (MINERAL OIL, PETROLATUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2807-2015·2015-09-30

    Olympus TJF-Q180V Duodenoscope Recall Issued for Revised Reprocessing Procedures

    Olympus America Inc. is recalling 6,109 TJF-Q180V duodenoscopes to implement new cleaning and disinfection procedures.

    Product
    EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for end
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2811-2015·2015-09-30

    Synthes Cranial Flap Tube Clamp Recalled for Incorrect MR Safe Labeling

    Synthes (USA) Products LLC is recalling Cranial Flap Tube Clamps and Crimping Devices because they were labeled MR Safe without required testing protocols.

    Product
    Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2815-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 982 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2808-2015·2015-09-30

    Bard Access Systems Recalls PowerPICC Catheter Marketing Brochures

    Bard Access Systems is recalling 1,811 marketing brochures for PowerPICC and PowerPICC SOLO catheters because they contain incorrect indications for use.

    Product
    Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2800-2015·2015-09-30

    Zien Medical PenBlade Safety Scalpel Recalled for Sterile Barrier Risk

    Zien Medical Technologies is recalling PenBlade Safety Scalpels because cracks in the PET trays may compromise the sterile barrier.

    Product
    PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1820-2015·2015-09-30

    Allergan Recalls Blephamide Ophthalmic Ointment Due to Particulate Matter

    Allergan is recalling 337 tubes of Blephamide ophthalmic ointment because small black particles from the tube cap may be present in the product.

    Product
    BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2817-2015·2015-09-30

    BD Biosciences Recalls CD4 FITC Reagent Due to Spanish Labeling Error

    Becton, Dickinson and Company is recalling 128 units of CD4 (SK3), FITC reagent because the Spanish text on the label incorrectly identifies the product as CD8 FITC.

    Product
    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2810-2015·2015-09-30

    Stryker Recalls Trident Hip Implant Components Due to Documentation Error

    Stryker Howmedica Osteonics is recalling 16 units of Trident hip implant inserts due to a documentation issue, despite the parts meeting all device specifications.

    Product
    Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2806-2015·2015-09-30

    Fujifilm EPX 2500 Processor Manual and Brochure Recall

    Fujifilm is recalling EPX 2500 Processor manuals and brochures that incorrectly identify the ED-530XT endoscope's image quality.

    Product
    Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·126-2015·2015-09-29

    Royal Frozen Food Recalls Frozen Beef and Pork Products for Allergen and HACCP Issues

    Royal Frozen Food is recalling approximately 230 pounds of frozen beef and pork products in California that were produced without a fully implemented HACCP plan and may contain undeclared egg.

    Product
    Royal Frozen Food — Royal Frozen Food Recalls Frozen Food Products Produced Without a Fully Implemented HACCP Plan, Containing an Undeclared Allergen, and Missing the Mark of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·15V608000·2015-09-29

    Ford Recalls 1998-2003 Windstar Minivans for Rear Axle Bracket Defect

    Ford is recalling 1998-2003 Windstar minivans because previously installed rear axle brackets may be misinstalled, potentially allowing the axle to fracture and increasing crash risk.

    Product
    FORD — FORD WINDSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V609000·2015-09-29

    GM Recalls 2016 Acadia, Traverse, Enclave for Wiper Motor Fire Risk

    General Motors is recalling 2016 Chevrolet Traverse, GMC Acadia, and Buick Enclave vehicles because the windshield wiper motor may overheat, increasing the risk of a fire.

    Product
    GMC — GMC, CHEVROLET, BUICK ACADIA, TRAVERSE, ENCLAVE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V606000·2015-09-29

    Ford Recalls 2001-2008 Escape and Mariner for Transmission Shift Lever Defect

    Ford is recalling 2001-2008 Escape and Mercury Mariner vehicles with specific remanufactured transmissions because the shift lever bolt may not be tightened, risking vehicle rollaway.

    Product
    FORD — FORD, MERCURY ESCAPE, MARINER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15253·2015-09-29

    Bicycles with Front Disc Brakes Recalled for Crash Hazard

    Thirteen manufacturers recall about 1.3 million bicycles with front disc brakes and quick-release levers due to a crash hazard. Consumers should stop using the bikes and contact the manufacturer for a free replacement.

    Product
    Bicycles equipped with front disc brakes and quick release levers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15256·2015-09-29

    Calphalon Recalls Pizza Wheels Due to Handle Detachment and Laceration Risk

    Calphalon is recalling pizza wheels because the handle can detach during use, posing a laceration hazard. Consumers should stop using the product and contact the company for a refund.

    Product
    Pizza wheel pizza cutters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15254·2015-09-29

    Madewell Recalls Katya Sandals Due to Metal Shank Fall Hazard

    Madewell is recalling Katya sandals because a metal shank can dislodge and break through the outsole, posing a fall hazard. No injuries have been reported.

    Product
    Sandals
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15255·2015-09-29

    Chewbeads Recalls Pacifier Clips Due to Choking Hazard

    Chewbeads is recalling approximately 45,000 pacifier clips in the U.S. because the D-ring can break, allowing beads to detach and pose a choking hazard.

    Product
    Pacifier clips
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15257·2015-09-29

    Ross Stores Recalls Rattan Arm Chairs Due to Fall Hazard

    Ross Stores is recalling rattan arm chairs because they may tip or slide backward, posing a fall hazard. Eight reports of minor injuries have been received.

    Product
    Rattan Arm Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V604000·2015-09-28

    Volvo Bus 9700 Recall: Exhaust Clamp Failure May Cause Fire

    Volvo is recalling 2009-2013 9700 buses because a failing exhaust clamp allows hot gas to contact engine materials, increasing fire risk.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V605000·2015-09-28

    Ford Recalls 2015 Taurus, MKS, and 2016 Explorer for Fuel Tank Defect

    Ford is recalling specific 2015 Taurus, Lincoln MKS, and 2016 Explorer vehicles because fuel tank bolts may not be tightened, risking tank separation and fire.

    Product
    FORD — FORD, LINCOLN TAURUS, MKS, EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V600000·2015-09-25

    Land Rover Recalls 2015 Range Rovers for Second Row Seat Latch Defect

    Jaguar Land Rover is recalling 856 model year 2015 Range Rover and Range Rover Sport vehicles because the second row seat back may not latch properly, increasing injury risk in a crash.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V601000·2015-09-25

    Merhow Recalls Horse Trailers Due to Door Lock Jamming Risk

    Merhow is recalling 2006-2013 Horse Trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    MERHOW — MERHOW HORSE TRAIELRS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·125-2015·2015-09-25

    Calperf Recalls Marinated Chicken Product Due to Undeclared Milk Allergen

    Calperf is recalling approximately 216 pounds of marinated chicken product because it contains milk, a known allergen, that is not declared on the ingredient list.

    Product
    CREATIVE FOOD PROCESSING — Calperf Recalls Chicken Product Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·15249·2015-09-24

    Fujitsu Recalls Notebook Computer Battery Packs Due to Fire Hazard

    Fujitsu America is recalling specific lithium-ion battery packs for notebook computers because they can overheat and catch fire. Consumers should remove the battery and contact Fujitsu for a free replacement.

    Product
    Fujitsu notebook computer battery packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·124-2015·2015-09-24

    Sanderson Farms Recalls Poultry Products Due to Metal Contamination

    Sanderson Farms is recalling approximately 554,090 pounds of chicken products that may contain metal shavings. The contamination resulted from a malfunctioning ice-making machine.

    Product
    Sanderson Farms Recalls Poultry Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·15V599000·2015-09-24

    GM Recalls 2006-2007 SUVs for Power Window Switch Fire Risk

    General Motors is recalling specific 2006-2007 Buick, Chevrolet, and GMC SUVs because fluid in the power window switch module can cause a short circuit and fire.

    Product
    BUICK — BUICK, CHEVROLET, GMC RAINIER, TRAILBLAZER, TRAILBLAZER EXT, ENVOY XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V595000·2015-09-24

    Chrysler Recalls 2016 Minivans for Hood Striker Bolt Issue

    Chrysler is recalling 2016 Town and Country and Dodge Grand Caravan minivans because hood striker bolts may loosen, allowing the hood to open while driving.

    Product
    DODGE — DODGE, CHRYSLER GRAND CARAVAN, TOWN AND COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V598000·2015-09-24

    E-One Recalls 2013-2014 Emergency Vehicles Due to Suspension Defect

    E-One is recalling 2013-2014 Typhoon, Cyclone II, and Quest emergency vehicles because loose front suspension ball joints could separate, causing loss of steering control.

    Product
    E-ONE — E-ONE CYCLONE II, TYPHOON, QUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V597000·2015-09-24

    Paccar Recalls 2016 Kenworth and Peterbilt Trucks Due to Engine Stalling Risk

    Paccar is recalling 354 model year 2016 Kenworth and Peterbilt trucks because a short circuit in the engine control module may cause the engine to stall without warning.

    Product
    PETERBILT — PETERBILT, KENWORTH 382, 567, 386, 365
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15251·2015-09-24

    Wishbone Recalls Recycled Edition Bikes Due to Finger Pinch Hazard

    Wishbone Design is recalling Recycled Edition Bikes because the handlebar can pinch fingers. The company reported four incidents, including two injuries requiring medical attention.

    Product
    Recycled Edition Bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15252·2015-09-24

    Bed Bath & Beyond Hammock Stands Recalled Due to Fall Hazard

    Pride Family Brands is recalling Bed Bath & Beyond Destination Summer Hammock Stands because the Z-shaped hooks can bend or break, causing consumers to fall.

    Product
    Destination Summer Hammock Stands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15E078000·2015-09-24

    Lippert Coachstep Electric Steps Recalled for Potential Instability

    Lippert is recalling Coachstep Double and Triple Electric Steps because a bolt may fracture, causing the steps to become unstable and increasing the risk of injury.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3227-2015·2015-09-23

    Trader Joe's Dark Chocolate Honey Grahams Recalled for Undeclared Milk

    Jo's Candies is recalling Trader Joe's Dark Chocolate covered Honey Grahams with Sea Salt due to undeclared milk.

    Product
    Trader Joe's Dark Chocolate covered Honey Grahams with Sea Salt NET Wt. 8oz. (227g) SKU #0055 0246 Product is packaged in 8oz. clear tubs.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F3236-2015·2015-09-23

    Kariba Farms Macadamia Meal Recalled for Salmonella Contamination

    Kariba Farms is recalling 1-pound bags of Macadamia Meal due to potential Salmonella contamination. The product was distributed in Georgia and Texas.

    Product
    Kariba Farms Macadamia Meal, 1 pound bags; Packed by: Kariba Farms, Denville, NJ 07834 Product of USA. www.KaribaFarms.com 1.800.442.1969.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-3234-2015·2015-09-23

    Jansal Valley Raw Macadamia Nuts Recalled for Salmonella Contamination

    Friendly Fruit, Inc. is recalling Jansal Valley brand Raw Macadamia Nuts due to Salmonella contamination. Consumers in eight states and D.C. should stop eating the product.

    Product
    Jansal Valley brand Raw Macadamia Nuts, packaged in 1 lb and 8 oz. plastic bags
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Devices)·Z-2731-2015·2015-09-23

    SynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure

    SynCardia Systems is recalling Freedom Drivers because a component may fail, causing the drive mechanism to stop pumping and resulting in the loss of life-sustaining function.

    Product
    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of immine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1683-2015·2015-09-23

    Lipo-B MMC I Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lipo-B MMC I Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1494-2015·2015-09-23

    Fentanyl Intrathecal Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Fentanyl 2,000 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1483-2015·2015-09-23

    FDA Recalls Fentanyl Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl intrathecal solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1566-2015·2015-09-23

    Mannitol 5% Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Mannitol 5% Injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1572-2015·2015-09-23

    Methylcobalamin Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Methylcobalamin 5,000 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide

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