The Recall Desk

Archive

August 2015 recalls

585 recalls were announced in August 2015.

What the numbers show

Critical
75
Severe
90
High
176
Moderate
225
Low
19

Of the 585 recalls this month scored against our rubric, 13% are Critical, 15% are Severe.

401–500 of 585

  • SevereNHTSA·15V500000·2015-08-10

    GM Recalls 2010 Chevrolet Cobalt Vehicles for Air Bag Wiring Defect

    General Motors is recalling 2010 Chevrolet Cobalt vehicles because a misrouted wiring harness may disable the driver-side curtain air bag, increasing injury risk in a crash.

    Product
    CHEVROLET — CHEVROLET COBALT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V503000·2015-08-10

    Goshen Coach Recalls 2014-2015 Vans Due to Loose Seat Bolts

    Goshen Coach is recalling 1,494 model year 2014-2015 vans because driver and passenger seat bolts may not be properly tightened, increasing injury risk in a crash.

    Product
    GOSHEN — GOSHEN PACER LS, COMMANDER, CONNECTION, SENTINEL UC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V499000·2015-08-10

    Keystone Recalls 2014-2016 RVs with Blocked Emergency Exit Windows

    Keystone RV Company is recalling certain 2014-2016 Avalanche, Alpine, and Laredo models because a rear window labeled as an emergency exit may be blocked by a ladder.

    Product
    KEYSTONE — KEYSTONE AVALANCHE, ALPINE, LAREDO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V502000·2015-08-10

    Subaru Recalls 2015-2016 Legacy and Outback for Transmission Fire Risk

    Subaru is recalling 2015-2016 Legacy and Outback vehicles because a deformed seal cap may allow transmission oil to leak onto the exhaust pipe, creating a fire risk.

    Product
    SUBARU — SUBARU LEGACY, OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·108-2015·2015-08-07

    Victor's Market Recalls Chicken Products Due to Misbranding

    Victor's Market Company is recalling approximately 7,368 pounds of chicken products because they were slaughtered under religious exemption, which was not declared on the label.

    Product
    Victor's Market Co Inc — Victor's Market Company Recalls Chicken Products Due to Misbranding
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·15V498000·2015-08-06

    LGS Recalls 2015-2016 Look, Pace, and Cargo Express Trailers

    LGS Industries is recalling 3,612 model year 2015-2016 Look, Pace, and Cargo Express trailers because the coupler latch may not fully lock, risking separation from the tow vehicle.

    Product
    LOOK — LOOK, PACE, CARGO EXPRESS CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V495000·2015-08-06

    Starcraft RV Recalls Launch Ultra Lite Trailers Due to Furnace Defect

    Starcraft RV is recalling 2015-2016 Launch Ultra Lite trailers because improperly secured furnaces may release hazardous exhaust fumes into the cabin.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT LAUNCH ULTRA LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·15210·2015-08-06

    Viking Range Recalls Dishwashers Due to Fire Hazard

    Viking Range is expanding a recall for about 17,300 dishwashers manufactured before April 2011 because an electrical component can overheat and cause fires.

    Product
    Dishwashers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V494000·2015-08-06

    Turtle Top Transit Buses Recalled for Window Loading Defect

    Turtle Top is recalling certain 2012 Van Terra XL and Odyssey XL transit buses because their windows may not meet federal safety loading requirements.

    Product
    TURTLE TOP — TURTLE TOP ODYSSEY XL MPV, VAN TERRA XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15208·2015-08-06

    Precious Cargo Recalls Infant One-Piece Garments Due to Choking Hazard

    Precious Cargo is recalling infant one-piece garments because the snaps can detach, posing a choking hazard to young children. No injuries have been reported.

    Product
    Precious Cargo infant one-piece garments
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2271-2015·2015-08-05

    Draeger Fabius MRI Anesthesia Machine Recalled for Magnetic Field Attraction

    Draeger Medical is recalling 373 Fabius MRI anesthesia machines because their parts can be loosened by the magnetic field of MRI equipment.

    Product
    Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2870-2015·2015-08-05

    Brett Anthony Foods Recalls Vegetable Chili for Undeclared Milk Allergen

    Brett Anthony Foods is recalling 8 oz Vegetable Chili containers in Illinois due to undeclared milk, a major food allergen.

    Product
    Vegetable Chili, 8 oz plastic container, labeled with a green and white label with green and white lettering.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2869-2015·2015-08-05

    Rising Sun Farms Recalls Nut Free Pesto Due to Listeria Contamination

    Rising Sun Farms Inc is recalling Nut Free Pesto due to contamination with Listeria monocytogenes. The product was distributed in Florida and Nevada.

    Product
    Nut Free Pesto, packaged in a institutional size 28 lbs. and 30 lbs. container, sold under brand Rising Sun Farms, UPC 0 18646 48075 9
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2209-2015·2015-08-05

    Skeletal Kinetics Recalls InjectionPlasty 1.0 Bone Void Filler Kits

    Skeletal Kinetics is recalling 67 kits of InjectionPlasty 1.0 Bone Void Filler due to reports of venous uptake, DVT, and pulmonary embolism in implanted patients.

    Product
    InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·15V493000·2015-08-05

    Forest River Recalls 2015-2016 XLR Trailers for Electrical Fire Risk

    Forest River is recalling 634 model year 2015-2016 XLR trailers because strained wiring at the external power inlet may loosen and arc, increasing the risk of a vehicle fire.

    Product
    FOREST RIVER — FOREST RIVER XLR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2015·2015-08-05

    Anspach 5MM Fluted Ball Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 79 Anspach 5MM Fluted Ball dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighNHTSA·15V492000·2015-08-05

    Newmar Recalls 2015-2016 Motor Homes Due to Air Suspension Defect

    Newmar is recalling 82 model year 2015-2016 Mountain Aire, King Aire, and Essex motor homes because the air suspension control module may lose power, potentially affecting vehicle control.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE, KING AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V490000·2015-08-05

    Winnebago Era Recalled for Incorrect Tire Pressure Certification Labels

    Winnebago is recalling 2012-2016 Era recreational vehicles because certification labels list incorrect front tire inflation pressures, which could lead to tire failure.

    Product
    WINNEBAGO — WINNEBAGO ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V491000·2015-08-05

    DRV Suites Recalls Fifth Wheel Travel Trailers for Reflector Placement

    DRV Suites is recalling specific fifth wheel travel trailers because front side reflex reflectors are located above the maximum height of 60 inches, failing to comply with FMVSS 108.

    Product
    DRV — DRV ELITE SUITES ALL, ESTATES ALL, TRADITION, FULL HOUSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V489000·2015-08-05

    Felling Recalls 2016 FT-6T Trailers Due to Tire Fender Rubbing

    Felling Trailers is recalling 92 model year 2016 FT-6T tilting trailers because improper fender placement may cause tires to rub, potentially leading to tire failure and a crash.

    Product
    FELLING — FELLING FT-6T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2057-2015·2015-08-05

    Hamilton-G5 Ventilators Recalled for Display Freeze Issue

    Hamilton Medical is recalling 248 Hamilton-G5 ventilators because the display can freeze, preventing users from operating the device while ventilation continues.

    Product
    Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2015·2015-08-05

    Anspach Diamond Ball Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 72 Anspach Extra Coarse Diamond Ball tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure.

    Product
    ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2267-2015·2015-08-05

    OxiMax N-65 Pulse Oximeters Recalled for Display Segment Defects

    FDA is recalling OxiMax N-65 handheld pulse oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.

    Product
    OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2015·2015-08-05

    Philips Brilliance iCT SP CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling two Brilliance iCT SP CT systems due to software issues affecting image quality, dose control, and heart rate measurement.

    Product
    Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2253-2015·2015-08-05

    OxySure Model 615 Oxygen Cartridges Recalled for Flow Rate Defect

    Oxysure Systems is recalling 1,005 Model 615 oxygen cartridges because they do not meet FDA flow rate standards.

    Product
    OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2015·2015-08-05

    OxiMax N-560 Pulse Oximeters Recalled for Display Segment Defects

    The FDA is recalling OxiMax N-560 Pulse Oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.

    Product
    OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2315-2015·2015-08-05

    Tornier Aequalis Humeral Nail Targeting Jig Recalled for Mast Separation

    Tornier, Inc. is recalling 99 Aequalis Humeral Nail Targeting Jigs because the mast can separate from the boom, potentially affecting surgical alignment and screw fixation.

    Product
    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2314-2015·2015-08-05

    Siemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error

    Siemens is recalling ACUSON S 1000, S 2000, and S 3000 ultrasound systems due to a potential measurement error in the Doppler manual trace tool that could lead to misdiagnosis.

    Product
    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 70 G1 dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighNHTSA·15V488000·2015-08-05

    Ameritrans 225 Recall: Back-Up Camera Displays Reversed Images

    Ameritrans is recalling 2015 225 vehicles because the back-up camera may display reversed images, increasing the risk of a crash.

    Product
    AMERITRANS — AMERITRANS 225
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2868-2015·2015-08-05

    Grand BK Corp. Recalls Nature RAW Cashews Due to Salmonella Contamination

    Grand BK Corp. is recalling Goodies By Nature RAW Cashews because of Salmonella contamination. The product was distributed in several states via H Mart stores.

    Product
    goodies by Nature RAW CASHEWS, NET WT. 9 oz (255g), held in clear plastic tubs, UPC code of 846034010055. Distributed By: Grand BK Corp. 47-08 Grand Ave. Maspeth, NY 11378. Product of India.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-2900-2015·2015-08-05

    Dairy Farmers of America Recalls Sandwich Mate Cheese Slices for Plastic Film

    Dairy Farmers of America is recalling specific Sandwich Mate cheese slices because a piece of plastic film might remain attached to the product.

    Product
    Imitation Pasteurized Process Cheese Food: . Sandwich MATE 12/10.67OZ Monterey JACK singles, IMIT WHT. 7103025182. Sandwich MATE 12/8OZ Monterey JACK singles, IMIT PP.99 WHT, 7103025185
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-2310-2015·2015-08-05

    Anspach Diamond Ball Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 70 Anspach 5MM Diamond Ball dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2283-2015·2015-08-05

    Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 177 fluted drum dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2259-2015·2015-08-05

    Philips Ingenuity CT Scanners Recalled for Software and Hardware Defects

    Philips is recalling 159 Ingenuity CT scanners due to software errors affecting dose control, image artifacts, and heart rate measurement.

    Product
    Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2261-2015·2015-08-05

    Otto Bock Recalls Pheon 3R62 Polycentric Prosthetic Knee Joints

    Otto Bock Healthcare GmbH is voluntarily recalling 3R62 Pheon prosthetic knee joints because the locking function may fail, potentially causing a fall.

    Product
    Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2015·2015-08-05

    Prism Medical P-440 Portable Ceiling Lift Recalled for Sling Attachment Risk

    Prism Medical is recalling P-440 Portable Ceiling Lifts because sling loops may not stay attached to the carry bar hooks.

    Product
    Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg). Product Usage: The P-440 lift is a lifting aid used by health care professionals and those providing care in the home to lift, positi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2281-2015·2015-08-05

    Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 138 fluted drum dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2307-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 99 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual usage, potentially resulting in greater exposure than specified.

    Product
    ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2245-2015·2015-08-05

    EXP Pharmaceutical Services Recalls TAUT Intraducer Peritoneal Catheters

    EXP Pharmaceutical Services Corp is recalling TAUT Intraducer Peritoneal Catheters because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2262-2015·2015-08-05

    Encore Medical Recalls Foundation Knee System Cut Blocks Due to Marking Error

    Encore Medical is recalling 10 units of Foundation Knee System cut blocks because markings are mis-oriented, which could lead to improper surgical cuts.

    Product
    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2305-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled Due to Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 70 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.

    Product
    ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2270-2015·2015-08-05

    Prism Medical P-600 Portable Ceiling Lift Recalled for Sling Attachment Risk

    Prism Medical is recalling 409 P-600 Portable Ceiling Lifts because sling loops may not stay attached to the carry bar hooks.

    Product
    Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weight specification of 600 lbs (273 kg). Product Usage: The P-600 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2015·2015-08-05

    Medtronic MiniMed Recalls 620G and 640G Insulin Pumps for Bolus Screen Issue

    Medtronic MiniMed is recalling 620G and 640G insulin pumps because the bolus screen may fail to timeout, displaying outdated dosing information.

    Product
    MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2258-2015·2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 139 Ingenuity Core 128 CT scanners due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2903-2015·2015-08-05

    Dairy Farmers of America Recalls Fat-Free Swiss Cheese Due to Plastic Film

    Dairy Farmers of America is recalling specific fat-free Swiss cheese products because plastic film strips may remain attached to the slices.

    Product
    Fat Free Pasteurized Prepared Cheese Product: HYVEE 12/12OZ FAT FREE SWISS CHS, 7545009327. BORDEN 12/12OZ SWISS FAT FREE WHT, 5300000679.
    Category
    Food
    Distribution
    39 states
  • HighFDA (Food)·F-2866-2015·2015-08-05

    Atkins Chocolate Candies Recalled for Potential Peanut Contamination

    Atkins Nutritionals is voluntarily recalling specific cartons of Atkins Chocolate Candies because they may contain sachets of Atkins Peanut Candies.

    Product
    Atkins Chocolate Candies  5 ct. cartons - UPC code 637480075558
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-2308-2015·2015-08-05

    Anspach 4mm Diamond Ball Dissection Tool Recall for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 246 units of the 4mm Diamond Ball dissection tool because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2255-2015·2015-08-05

    Philips Brilliance iCT CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 38 Brilliance iCT CT systems due to software errors affecting dose control, heart rate measurement, and image artifacts.

    Product
    Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2015·2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 82 Ingenuity Core CT systems due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2015·2015-08-05

    Symmetry Surgical Disposable Towel Clamp Recalled for Sterility Assurance

    Symmetry Surgical is recalling 2,708 units of disposable towel clamps due to a lack of sterility assurance. The affected sterile products were distributed in the US, Germany, and Mexico.

    Product
    SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.
    Category
    Medical Device
    Distribution
    18 states
  • HighCPSC·15207·2015-08-05

    MZB Recalls Children's Watches Due to Risk of Skin Irritation

    MZB is recalling about 1.9 million children's watches because the case-back can detach, exposing the interior to water and causing skin irritation or chemical burns.

    Product
    MZB Children's "Light Up" Watches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1280-2015·2015-08-05

    Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

    Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.

    Product
    Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2217-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered GIA Auto Suture Loading Units

    EXP Pharmaceutical Services Corp is recalling GIA Auto Suture Loading Units because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien (OEM) Implantable Staple
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2232-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Laparoscopic Insufflation Needles

    EXP Pharmaceutical Services Corp is recalling two units of laparoscopic insufflation needles due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2234-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders

    EXP Pharmaceutical Services Corp is recalling 12mm vascular transcatheter septal occluders because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2241-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Stryker Round Fluted Bur Devices

    EXP Pharmaceutical Services Corp is recalling six Stryker Round Fluted Bur devices due to the company's failure to register as a medical device establishment.

    Product
    Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-240; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2280-2015·2015-08-05

    Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 65 Fluted Drum dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure.

    Product
    ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2244-2015·2015-08-05

    EXP Pharmaceutical Services Recalls SECURESTRAP Absorbable Strap Fixation Devices

    EXP Pharmaceutical Services Corp is recalling SECURESTRAP 5mm Absorbable Strap Fixation Devices because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2235-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging

    EXP Pharmaceutical Services Corp is recalling a medical device exchange product because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2887-2015·2015-08-05

    Dairy Farmers of America Recalls Cheese Products Due to Plastic Film Hazard

    Dairy Farmers of America is recalling specific Borden and Cumberland cheese products because plastic film strips may remain attached to the slices.

    Product
    Pasteurized Prepared Cheese Product: BORDEN 12/12OZ WHITE AMER CHEESE PROD , 5300001636. CUMBERLAND 12/8OZ AMER CHEESE PROD WHITE, 4270401171
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2302-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 88 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.

    Product
    ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2233-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders

    EXP Pharmaceutical Services Corp is recalling 10MM Vascular Transcatheter Septal Occluders because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2311-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 80 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.

    Product
    ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2274-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Clinical Culture Media Due to Lack of Clearance

    Hardy Diagnostics is recalling several clinical culture media products, including BHI with Ciprofloxacin, because they lack FDA 510(k) clearance.

    Product
    Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical sampl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2214-2015·2015-08-05

    EXP Recalls 5.5mm BioComposite Corkscrew Suture Anchor Due to Registration Failure

    EXP Pharmaceutical Services Corp is recalling 5.5mm BioComposite Corkscrew Suture Anchors because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-1927BCF; EXP (repackager), Arthrex (OEM) Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2290-2015·2015-08-05

    Anspach Fluted Ball Dissection Tools Recalled for Labeling Inconsistency

    The Anspach Effort, Inc. is recalling 353 Fluted Ball dissection tools because the labeled shaft exposure may be inconsistent with actual usage.

    Product
    ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2212-2015·2015-08-05

    EXP Pharmaceutical Services Recalls GelPort Laparoscopic Systems for Registration Violations

    EXP Pharmaceutical Services Corp is recalling three GelPort Laparoscopic Systems because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2872-2015·2015-08-05

    Dairy Farmers of America Recalls Imitation Cheese Due to Plastic Film

    Dairy Farmers of America is recalling specific imitation cheese products because a piece of plastic film might remain attached to the cheese slice.

    Product
    Imitation Pasteurized Process Cheese Food: SANDWICH MATE 24/6.56OZ IMITATION WHITE, 7103026288. VALU TIME 12/10.67 OZ AMER IMITATION WHITE, 1122509215. SANDWICH MATE 12/8OZ AMER IMITATION PASTEURIZED PROCCESS.99 WHITE, 7103025055.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-1281-2015·2015-08-05

    Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations

    Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.

    Product
    Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2210-2015·2015-08-05

    MTF Recalls Allograft Cortical Pins Due to Diameter Labeling Error

    Musculoskeletal Transplant Foundation is recalling one lot of Allograft Cortical Pins because the 2.0 mm label may contain 2.4 mm pins.

    Product
    Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2275-2015·2015-08-05

    Hardy Diagnostics Recalls MDR Acinetobacter and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling MDR Acinetobacter and other diagnostic media because they lack FDA 510(k) clearance.

    Product
    Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2252-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Tracheal Stent Sizing Devices

    EXP Pharmaceutical Services Corp is recalling two units of tracheal stent sizing devices due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2265-2015·2015-08-05

    Ivoclar Vivadent Recalls IPS Empress Universal Glaze Spray Due to Coarse Particles

    Ivoclar Vivadent is recalling IPS Empress Universal Glaze Spray because complaints indicated coarse particles in the glazed surface of dental restorations.

    Product
    IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2215-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging

    EXP Pharmaceutical Services Corp is recalling four units of Trocar VersaPort Plus V2 devices because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2238-2015·2015-08-05

    EXP recalls Stryker Round Fluted Burs due to registration violations

    EXP Pharmaceutical Services Corp is recalling Stryker Round Fluted Burs because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2213-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Sterile Laparoscope Pouches

    EXP Pharmaceutical Services Corp is recalling seven sterile laparoscope pouches because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2876-2015·2015-08-05

    Dairy Farmers of America Recalls Fat-Free Cheese Products Due to Plastic Film

    Dairy Farmers of America is recalling specific fat-free cheese products because a piece of plastic film strip might remain attached to the cheese slice.

    Product
    Non-Fat Pasteurized Prepared Cheese Product: FOOD CLUB 12/12OZ AMER FAT FREE YELLOW, 3680045432. SHOPPRITE 12/12OZ AMER FAT FREE YLW, 4119045837. MEIJER 12/12 OZ AMERICAN FAT FREE COLOR, 4125056702. SCHNUCKS 12/12OZ AMER FAT FREE YLW, 4131858109.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Food)·F-2888-2015·2015-08-05

    Dairy Farmers of America Recalls Borden Grilled Cheese Melts for Plastic Film

    Dairy Farmers of America is recalling Borden Grilled Cheese Melts because a piece of plastic film might remain attached to the cheese slice.

    Product
    Pasteurized Prepared Cheese Product: .BORDEN 12/10.67OZ GRILLED CHEESE MELTS YLW PP2.99, 5300000429. BORDEN 12/12OZ GRILLED CHEESE MELTS YLW, 5300000436. BORDEN 48/12 OZ GRILLED CHEESE MELTS , 5300000436.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Food)·F-2902-2015·2015-08-05

    Dairy Farmers of America Recalls Fat Free White American Cheese Slices

    Dairy Farmers of America is recalling fat free white American cheese singles because plastic film strips may remain attached to the slices.

    Product
    Fat Free Pasteurized Prepared Cheese Product: ESSENTIAL EVERYDAY 12/10.7OZ SINGLES WHITE AMERICAN, FF IWS AMER PROC WHT, 4130300848. BORDEN 12/12OZ AMERICAN FAT FREE WHT, 5300001675.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Food)·F-2882-2015·2015-08-05

    Dairy Farmers of America Recalls Borden Pepper Jack Cheese Due to Plastic Film

    Dairy Farmers of America is recalling Borden 2% Pepper Jack White cheese because plastic film strips may remain attached to the slices.

    Product
    Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/12OZ 2% PEPPER JACK WHITE, 5300000619.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Food)·F-2881-2015·2015-08-05

    Dairy Farmers of America Recalls Cheese Products Due to Plastic Film Hazard

    Dairy Farmers of America is recalling reduced-fat cheese products because a piece of plastic film strip might remain attached to the cheese slice.

    Product
    Reduced Fat Pasteurized Prepared Cheese Product: MEIJER 12/12OZ 2PCT AMER YLW,4125005136. ESSENTIAL EVERYDAY 12/10.7 OZ 2% AMER PROC YLW, 4130300844. BORDEN 12/6.56OZ 2% AMER YLW, 5300000605. BORDEN 12/10.67OZ 2% AMER SINGLES,2.99, 5300000693. HARRIS TEETER 12/12OZ 2% A
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Food)·F-2880-2015·2015-08-05

    Dairy Farmers of America Recalls American Cheddar Flavor Slices

    Dairy Farmers of America is recalling American Cheddar Flavor Slices because a piece of plastic film might remain attached to the cheese.

    Product
    American Cheddar Flavor Slices: SOYA KAAS 12/8OZ AMERICAN CHEDDAR FLAVOR SLICES, 7801600480.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Food)·F-2873-2015·2015-08-05

    Dairy Farmers of America Recalls Marvella American Cheese Due to Plastic Film

    Dairy Farmers of America is recalling Marvella American Pasteurized Cheese Singles because a piece of plastic film might remain attached to the cheese slice.

    Product
    American Pasteurized Cheese Product: MARVELLA 12OZ 340G AMERICAN PASTEURIZED CHEESE, SINGLES, 5193319275.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Food)·F-2891-2015·2015-08-05

    Dairy Farmers of America Recalls Pepper Jack Cheese Due to Plastic Film

    Dairy Farmers of America is recalling Sensations Southwest Pepper Jack cheese because plastic film strips may remain attached to the slices.

    Product
    Pasteurized Prepared Cheese Product: SENSATIONS 12/8OZ SOUTHWEST PEPPER JACK WHT, 5300000990.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Food)·F-2875-2015·2015-08-05

    Dairy Farmers of America Recalls Borden Sensations Applewood Bacon Cheddar

    Dairy Farmers of America is recalling Borden Sensations Applewood Bacon Cheddar because a piece of plastic film might remain attached to the cheese slice.

    Product
    FLAVORED PASTEURIZED PREPARED CHEESE PRODUCT BORDEN SENSATIONS 12/8OZ APPLEWOOD BACON CHEDDAR 5300000980
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-1279-2015·2015-08-05

    Boehringer Ingelheim Recalls Defective Combivent Respimat Inhalers

    Boehringer Ingelheim is recalling 358,647 Combivent Respimat inhalers because the delivery system may fail to spray properly.

    Product
    COMBIVENT RESPIMAT — COMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2301-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 95 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2286-2015·2015-08-05

    Anspach Fluted Barrel Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 110 Anspach Fluted Barrel dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure.

    Product
    ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2227-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Implantable Skin Staple Systems

    EXP Pharmaceutical Services Corp is recalling three units of implantable skin staple systems because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2285-2015·2015-08-05

    Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 115 fluted drum dissection tools because the specified shaft exposure may be inconsistent with certain attachments, potentially resulting in greater exposure than labeled.

    Product
    ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2284-2015·2015-08-05

    Anspach Fluted Acorn Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 227 Fluted Acorn dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states

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