The Recall Desk

Archive

November 2013 recalls

588 recalls were announced in November 2013.

What the numbers show

Critical
11
Severe
105
High
243
Moderate
221
Low
8

Of the 588 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

1–100 of 588

  • SevereNHTSA·13V597000·2013-11-29

    NABI Recalls 2013 Transit Buses Due to Wheel Lug Nut Loosening Risk

    North American Bus Industries is recalling 2013 31LFW and 40LFW transit buses because excessive paint on steel wheels may cause lug nuts to loosen, potentially leading to wheel detachment.

    Product
    NABI — NABI 31LFW, 40LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E065000·2013-11-29

    Airtex Recalls Fuel Pumps for Subaru Outback, Legacy, and Baja

    Airtex is recalling specific aftermarket fuel pumps for Subaru vehicles that may leak fuel when the tank is full, increasing fire risk.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY, BAJA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V605000·2013-11-29

    Daimler Recalls 2008-2009 Sterling Bullet Trucks for Tie Rod Fracture Risk

    Daimler Trucks North America is recalling 2,564 model year 2008-2009 Sterling Bullet trucks because the left outer tie rod ball stud may fracture, potentially causing loss of steering control.

    Product
    STERLING — STERLING BULLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V618000·2013-11-29

    Volvo Recalls 2014 Trucks Due to Seat Belt Buckle Defect

    Volvo is recalling 5,486 model year 2014 trucks because seat belt buckles may fail to release, hindering emergency egress.

    Product
    VOLVO — VOLVO VAH, VNM, VHD, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V606000·2013-11-29

    Thomas Built Buses Recall School Buses for Seat Belt Defect

    Daimler Trucks North America is recalling 2013-2015 Thomas Built school buses because seat belt buckles may fail to release, hindering emergency egress.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES, THOMAS BUILT SAF-T-LINER HDX, MINOTOUR, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V619000·2013-11-29

    Mack Trucks Recalls 2014 CXU and MRU Models for Seat Belt Defect

    Mack Trucks is recalling 2014 CXU and MRU trucks because seat belt buckles may fail to release, potentially hindering emergency egress.

    Product
    MACK — MACK MRU, PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V604000·2013-11-29

    Daimler Trucks Recalls 2014 Freightliner and Western Star Models for Seat Belt Defect

    Daimler Trucks North America is recalling 26,310 model year 2014 Freightliner and Western Star trucks because seat belt buckles may fail to release properly, hindering emergency egress.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR CASCADIA, 6900, CORONADO, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V601000·2013-11-29

    E-One Recalls 2013 Fire Fighting Vehicles for Seat Belt Defect

    E-One is recalling 2013 Quest, Cyclone II, and Typhoon fire fighting vehicles because seat belt buckles may fail to release, hindering emergency egress.

    Product
    E-ONE — E-ONE CYCLONE II, TYPHOON, QUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0261-2014·2013-11-27

    Medtronic Cougar Nitinol Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling specific Cougar Nitinol Workhorse Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0217-2014·2013-11-27

    Terri Lynn Deluxe Mixed Nuts Recalled for Undeclared Peanuts

    Terri Lynn Inc. is recalling Deluxe Mixed Nuts labeled 'No Peanuts' because the bags contain undeclared peanuts.

    Product
    Mixed nuts in a plastic bag labeled in part: PREMIUM QUALITY; Terri Lynn Inc.; Deluxe Mixed; No Peanuts; NET WT. 16 OZ. (1 LB.) 454 g; P.O. BOX 5118 ELGIN, IL 60121
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0183-2014·2013-11-27

    Trader Joe's Southwest Salad Recalled for Undeclared Soy

    World Class Distribution is recalling Trader Joe's Southwest Salad with Use by Date 11/2/13 due to undeclared soy.

    Product
    Trader Joe's Southwest Salads, 9oz. Packaged in plastic clamshell with ranch dressing packaged in plastic sealed solo cup. Product labeling reads in part:"TRADER JOE'S ***SOUTHWEST SALAD with Black Beans, Corn, Cotija Cheese and a tangy Ranch Dressing***NET WT. 9 OZ (255g)*
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0370-2014·2013-11-27

    FDA Recalls Medcare Max-500 Patient Lifts Due to Potential Load Failure

    Ergosafe Products LLC is recalling 97 Medcare Max-500 patient stands because the lift might fail with the labeled 500-lb load rating.

    Product
    Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0180-2014·2013-11-27

    Pro Thera Dual Detox Dietary Supplement Recalled for Chloramphenicol Contamination

    ProThera, Inc. is recalling Pro Thera Dual Detox Dietary Supplement because the enzyme Xylanase ingredient was found to be contaminated with chloramphenicol.

    Product
    Pro Thera Dual Detox Dietary Supplement; 60 capsules; Chlorella - 500 mg; Broccoli Sprout, dried extract - 60 mg; Enzyme Blend - supplying Beta-Glucanase, Cellulase, Protease, Hemicellulase, Phytase and Xylanase Manufactured by ProThera, Reno, NV,
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0226-2014·2013-11-27

    Sunny Pine Farm Recalls Organic Black Pepper Garlic Chevre for Pasteurization Concerns

    Sunny Pine Farm is voluntarily recalling Organic Black Pepper Garlic Chevre due to possible improper pasteurization. The product was sold in Washington state.

    Product
    Organic Black Pepper Garlic Chevre is sold in 3 lbs. vacuum plastic bag without labels since it sold to restaurants. However, the retail label is read in parts: "***Organic Goat Dairy***Black Pepper Garlic Chevre***6 oz***SUNNY PINE FARMS***Handcrafted in Twisp, Washington 988
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-001-2014·2013-11-27

    Teva Recalls Copaxone Syringes Due to Foreign Particulate Matter

    Teva Pharmaceuticals is recalling 6,803 cartons of Copaxone pre-filled syringes because a foreign particle was found in one unit.

    Product
    COPAXONE — COPAXONE (GLATIRAMER ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0218-2014·2013-11-27

    Terri Lynn Deluxe Mixed Nuts Recalled for Undeclared Peanuts

    Terri Lynn Inc. is recalling Deluxe Mixed Nuts with Macadamia because the bags contain undeclared peanuts, posing a risk to people with peanut allergies.

    Product
    Mixed nuts in a plastic bag labeled in part: Deluxe Mixed Nuts with Macadamia; NET WT. 12 OZ. (340 g), 30 LB, 35 LB; P.O. BOX 5118 ELGIN, IL 60121
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0348-2014·2013-11-27

    Candela Laser GentleLase Pro Recalled for Unintended Pulse Emission Risk

    Candela Corporation is recalling 1,258 GentleLase Pro laser surgical instruments because they may emit an unintended single pulse before the trigger is pressed, posing an injury risk.

    Product
    Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0178-2014·2013-11-27

    Bio-Cat Recalls Xylanase Enzyme Blends Due to Chloramphenicol Contamination

    Bio-Cat Inc is recalling bulk xylanase enzyme blends intended for food and dietary supplement manufacturing due to potential chloramphenicol contamination.

    Product
    Xylanase Enzyme Blends, bulk, custom blended formulations identified as xylanase 1000, xylanase 150,000 XU, synerzyme-ae, brizyme, Cellulase Special Blend OMRI, xylanase amylase blend, Bio-Cat Ruminant Enzyme, Feed Blend ws alkacel 20x, BC-XR, enzyme blend #2237, CHX blend, EB-7
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-015-2014·2013-11-27

    Affirm XL Nutritional Supplement Recalled for Unapproved Sildenafil Analogue

    Affirm XL is recalling its nutritional supplement because FDA analysis found it contains sulfoaildenafil, an unapproved analogue of sildenafil.

    Product
    Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-011-2014·2013-11-27

    Greenstone Recalls Spironolactone Tablets Due to Unapproved Manufacturing Site Change

    Greenstone LLC is recalling 4,848 bottles of Spironolactone 50 mg tablets because the manufacturing site change resulted in an unapproved dissolution profile.

    Product
    Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0352-2014·2013-11-27

    Spacelabs recalls anesthesia workstation absorbers due to potential switch failure

    Spacelabs Healthcare is recalling CAS I/II Absorbers for Blease anesthesia workstations because the Bag-to-Vent switch may fail due to loose hardware.

    Product
    CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anest
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0264-2014·2013-11-27

    Medtronic ProVia Crossing Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling ProVia Crossing Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0177-2014·2013-11-27

    Bio-Cat Recalls Pectinase Enzyme Blends Due to Chloramphenicol Contamination

    Bio-Cat Inc is recalling bulk pectinase enzyme blends intended for food and dietary supplement manufacturing because they may be contaminated with chloramphenicol.

    Product
    Pectinase Enzyme Blends, bulk, custom blended formulations identified as pectinase 500, pectinase 1000, Pectinase 350 Endo-pg/gm, PC Blend 14, Nut 14-500, pectinase 3500, gastro blend 0111, Digestive Blend 021894, enzyme complex 5763, pectinase 1750, pectinase 350, EC-CHPX, enzym
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0268-2014·2013-11-27

    Medtronic Zinger Steerable Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling Zinger Steerable Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0179-2014·2013-11-27

    Lifeforce Medical Institute Ultra Power Dietary Supplement Recalled for Contamination

    ProThera, Inc. is recalling Lifeforce Medical Institute Ultra Power dietary supplements because the enzyme Xylanase ingredient was found to be contaminated with chloramphenicol.

    Product
    Lifeforce Medical Institute Ultra Power; Optimal Vitamin/Mi neral. Trace Element/Anti-Oxidant Detox Support Dietary Supplement. 10 tablets/Packet and 30 packets/1000cc bottle. Distributed by: Mark Rosenbloom, MD LIFEFORCE Medical Institute 60 Revere Dr., Ste. 820 Northbr
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0362-2014·2013-11-27

    Ossur Fixed Offset Adapter Recalled for Fatigue Cracks and Separation Risk

    Ossur North America Inc is voluntarily recalling 66 units of the A-642100 Fixed Offset Adapter because the component can develop fatigue cracks and separate completely during normal use.

    Product
    Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the t
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Drugs)·D-013-2014·2013-11-27

    Hospira Recalls Ondansetron Injection Vials Due to Glass Spicules

    Hospira Inc. is recalling 681,400 vials of Ondansetron Injection because glass spicules were found during a site inspection.

    Product
    ONDANSETRON — ONDANSETRON (ONDANSETRON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0266-2014·2013-11-27

    Medtronic Cougar Steerable Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 20 units of Cougar Steerable Guidewires because the PTFE coating may delaminate and detach.

    Product
    COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2014·2013-11-27

    Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters and Cables

    Stryker Sustainability Solutions is recalling 46 reprocessed diagnostic electrophysiology catheters and cables due to a potential sterility breach in the package seal.

    Product
    Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed di
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0349-2014·2013-11-27

    Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling GemStar infusion pumps because pressure sensor calibration drift may cause the device to fail occlusion tests or report false errors.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0267-2014·2013-11-27

    Medtronic Thunder Steerable Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 1,205 Thunder Steerable Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0188-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Orange Drink Due to Cap Hazard

    American Beverage Corp. is recalling Big Burst Orange Drink in 16 oz PET bottles because the nozzle cap may dislodge and be ingested.

    Product
    Big Burst Orange Drink in a 16 oz PET bottle with a sports cap, American Beverage Corp., Verona, PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2014·2013-11-27

    Stryker Spine Recalls XIA Torque Wrenches Due to Fracturing Hex Tips

    Stryker Spine is recalling XIA and Mantis Redux torque wrenches because the hex tips may fracture during final tightening.

    Product
    Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0330-2014·2013-11-27

    GE Centricity Laboratory Software Recalled for Panel Reflex Failure

    GE Healthcare is recalling Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because panel reflexing may fail under specific conditions.

    Product
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical res
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2014·2013-11-27

    Synthes Soft Tissue Retractor Recalled for Potential Nut Breakage

    Synthes USA HQ, Inc. is recalling 374 Soft Tissue Retractors because the locking screw nut may break if overtightened.

    Product
    Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0182-2014·2013-11-27

    Krispak Recalls Good Sense Spicy Sweet Mix for Undeclared Allergens

    Krispak Inc. is voluntarily recalling one lot of Good Sense Spicy Sweet Mix because it was mislabeled, resulting in undeclared almond and cashew allergens.

    Product
    Good Sense Spicy Sweet Mix, 25-oz (1lb 9oz) plastic container, UPC: 030243787178
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0364-2014·2013-11-27

    Biomet Recalls Juggerknotless Drill Bits Due to Insertion Difficulty

    Biomet, Inc. is recalling 25 units of Juggerknotless Drill Bits because the design may make it difficult to insert the suture anchor into the bone.

    Product
    Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0211-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Fruit Punch Drink Due to Cap Hazard

    American Beverage Corp. is recalling Big Burst Fruit Punch Drink because the sports cap nozzle may dislodge and be ingested, posing a health hazard.

    Product
    Big Burst Fruit Punch Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0202-2014·2013-11-27

    American Beverage Corp. Recalls Big Hug Fruit Barrel Grape Bottles

    American Beverage Corp. is recalling Big Hug Fruit Barrel Grape bottles due to a potential choking hazard from dislodged nozzle cap parts.

    Product
    Big Hug Fruit Barrel Grape in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2014·2013-11-27

    Spacelabs qube Patient Monitor Recalled for Power-On Failure

    Spacelabs Healthcare is recalling 54 qube Compact Patient Monitors because an incorrect microcontroller may prevent the device from powering on.

    Product
    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0207-2014·2013-11-27

    Big Hug Lemon Lime Fruit Drink Recalled for Potential Cap Ingestion Hazard

    American Beverage Corp. is recalling Big Hug Lemon Lime Fruit Drink bottles due to a risk that nozzle cap parts could be ingested after excessive chewing.

    Product
    Big Hug Lemon Lime Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry CK Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CK Slides due to slide dispense issues. The recall affects 86,503 units distributed worldwide.

    Product
    VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2014·2013-11-27

    Aesculap Arcadius XP L Trial Insertion Instrument Recall for Weak Weld

    Aesculap is recalling 30 Arcadius XP L Trial Insertion Instruments because a weak weld may cause the device to disassemble during use.

    Product
    Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0195-2014·2013-11-27

    American Beverage Recalls Guzzler Alpine Freeze Bottles Due to Cap Hazard

    American Beverage Corp is recalling Guzzler Alpine Freeze bottles because the sports cap nozzle may dislodge if chewed, posing a choking or ingestion risk.

    Product
    Guzzler Alpine Freeze, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2014·2013-11-27

    Medtronic Zinger Guidewires Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling Zinger Stainless Steel Workhorse Guidewires because the PTFE coating may delaminate and detach.

    Product
    Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or intervent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2014·2013-11-27

    Stryker Rose Bed Siderail Latch Failure Recall

    Stryker is recalling Model FL14E Rose Beds because siderails may appear latched when they are not, posing a risk of patient injury.

    Product
    Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and lat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0197-2014·2013-11-27

    American Beverage Recalls Guzzler Citrus Punch Due to Cap Hazard

    American Beverage Corp is recalling Guzzler Citrus Punch because a part of the nozzle cap may dislodge and be ingested.

    Product
    Guzzler Citrus Punch, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0194-2014·2013-11-27

    Guzzler Kiwi-Strawberry Beverage Recalled for Potential Cap Fragment Ingestion

    American Beverage Corp is recalling Guzzler Kiwi-Strawberry beverages because a part of the nozzle cap may dislodge and be ingested.

    Product
    Guzzler Kiwi-Strawberry, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2014·2013-11-27

    Biomet Spine Recalls Polaris Translation Screws Due to Head Dissociation

    Biomet Spine is recalling 7,092 Polaris Translation Screws because the screw head may separate from the shaft. The recall covers nationwide distribution including Puerto Rico.

    Product
    BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2014·2013-11-27

    Medtronic Vascular Recalls Attain Hybrid Guide Wires Due to Coating Defect

    Medtronic Vascular is recalling 1,674 Attain Hybrid Guide Wires because the PTFE coating may delaminate and detach from the device.

    Product
    ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2014·2013-11-27

    Olympus Endoscopic Flushing Pump Recalled for Potential Standby Mode Failure

    Olympus America Inc. is recalling 263 Endoscopic Flushing Pumps because the pump head may not be locked, potentially causing the device to stop and enter power stand-by mode during procedures.

    Product
    Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0221-2014·2013-11-27

    Trader Joe's Caesar Salad Recalled for Undeclared Allergens

    Ghiringhelli Specialty Foods is recalling Trader Joe's Caesar Salads due to undeclared soy, fish, and wheat allergens.

    Product
    Trader Giotto's CAESAR Salad with Caesar Dressing; Perishable, keep refrigerated. Packaged in Net Wt. 8.5 oz (241 g) plastic clamshell. Manufactured for Trader Joe's Manufactured by Ghiringhelli Specialty Foods, inc. Vallejo, CA 94950.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0209-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Grape Drink Due to Cap Hazard

    American Beverage Corp. is recalling Big Burst Grape Drink because a part of the nozzle cap could become dislodged and ingested, posing a health hazard.

    Product
    Big Burst Grape Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0181-2014·2013-11-27

    Kerry Foods Recalls Idahoan Steakhouse Parmesan Topping Due to Salmonella Risk

    Kerry Foods is recalling Idahoan Steakhouse Parmesan topping because it was produced on equipment that processed a product testing positive for Salmonella.

    Product
    Idahoan, Steakhouse Parmesan topping, Net Weight 35 lbs., Item Code ZID800Bulk.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0224-2014·2013-11-27

    Sunny Pine Farm Recalls Organic Parsley Chive Chevre for Pasteurization Concerns

    Sunny Pine Farm is voluntarily recalling Organic Parsley Chive Chevre due to possible improper pasteurization. The product was sold in Washington state.

    Product
    Organic Parsley Chive Chevre sold to non-restaurant in plastic 6 oz plastic tub vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Product sold to restaurant is in 1 lb. and 2 lbs. size. The product is labeled in parts: "***Organic Goat Dairy***Parsley C
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0206-2014·2013-11-27

    Big Hug Lemonade Fruit Drink Recalled for Potential Cap Fragment Ingestion

    American Beverage Corp is recalling Big Hug Lemonade Fruit Drink because a part of the nozzle cap could become dislodged and ingested, posing a health hazard.

    Product
    Big Hug Lemonade Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0199-2014·2013-11-27

    American Beverage Corp Recalls Big Juicy Grape Drink Due to Cap Hazard

    American Beverage Corp is recalling Big Juicy Grape Drink because the sports cap nozzle may dislodge and be ingested. The firm does not anticipate finding impacted product in the market.

    Product
    Big Juicy Grape Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0204-2014·2013-11-27

    American Beverage Corp. Recalls Big Hug Fruit Barrel Citrus Bottles

    American Beverage Corp. is recalling Big Hug Fruit Barrel Citrus bottles due to a potential choking hazard from dislodged nozzle cap parts.

    Product
    Big Hug Fruit Barrel Citrus in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0373-2014·2013-11-27

    GE Vivid E9 Ultrasound Systems Recalled for Software Lockup

    GE Healthcare is recalling 710 Vivid E9 ultrasound systems worldwide due to a software defect that can cause the system to slow down and lock up during critical procedures.

    Product
    GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0205-2014·2013-11-27

    American Beverage Corp. Recalls Big Hug Fruit Barrel Kiwi Strawberry Bottles

    American Beverage Corp. is recalling Big Hug Fruit Barrel Kiwi Strawberry bottles due to a potential choking hazard from dislodged nozzle cap parts.

    Product
    Big Hug Fruit Barrel Kiwi Strawberry, in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0215-2014·2013-11-27

    New Algae Company Recalls EDGE Dietary Supplement for Undeclared Shark Cartilage

    New Algae Company is recalling EDGE dietary supplement packets because the label fails to declare shark cartilage. The product was distributed nationwide.

    Product
    EDGE, Item number 21-620, dietary supplement, 60 packet per box. The Edge product includes two different packets of capsules - a "Before" packet and an "After" packet. The suggested use for the After packet is one packet (or 6 capsules) per day. The suggested use for the
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0198-2014·2013-11-27

    American Beverage Recalls Big Juicy Blue Raspberry Drink Due to Cap Hazard

    American Beverage Corp is recalling Big Juicy Blue Raspberry Drink bottles due to a potential nozzle cap dislodgement hazard. The firm anticipates finding no impacted product in the market.

    Product
    Big Juicy Blue Raspberry Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0210-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Lemon Lime Drink Bottles

    American Beverage Corp. is recalling Big Burst Lemon Lime Drink bottles due to a potential choking hazard from dislodged nozzle cap parts.

    Product
    Big Burst Lemon Lime Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2014·2013-11-27

    Zeiss IOLMaster 500 Recalled for Erroneous Lens Database Value

    Carl Zeiss Meditec is recalling 1,201 IOLMaster 500 devices because an incorrect database value for the AMO Sensar AR40E lens could lead to the implantation of lenses with the wrong diopter.

    Product
    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use prima
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0214-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Citrus Punch Drink Bottles

    American Beverage Corp. is recalling Big Burst Citrus Punch Drink bottles due to a potential choking hazard from the sports cap nozzle.

    Product
    Big Burst Citrus Punch Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0192-2014·2013-11-27

    American Beverage Recalls Guzzler Island Punch Due to Cap Hazard

    American Beverage Corp is recalling Guzzler Island Punch 20 fl. oz. bottles because a part of the nozzle cap may dislodge and be ingested.

    Product
    Guzzler Island Punch 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0203-2014·2013-11-27

    American Beverage Corp. Recalls Big Hug Fruit Barrel Fruit Punch

    American Beverage Corp. is recalling Big Hug Fruit Barrel Fruit Punch because the sports cap may dislodge and be ingested.

    Product
    Big Hug Fruit Barrel Fruit Punch in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0193-2014·2013-11-27

    Guzzler Iced Tea Recalled for Potential Sports Cap Ingestion Hazard

    American Beverage Corp is recalling Guzzler Iced Tea due to a potential risk that a part of the sports cap could be ingested after excessive chewing.

    Product
    Guzzler Iced Tea 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2014·2013-11-27

    FDA Recalls Medcare Max-500 Patient Stands Due to Load Failure Risk

    Ergosafe Products LLC is recalling 233 Medcare Max-500 patient stands because the lift mechanism might fail under the labeled 500-lb load rating.

    Product
    Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0212-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Blue Raspberry Drink Due to Cap Hazard

    American Beverage Corp. is recalling Big Burst Blue Raspberry Drink because the sports cap nozzle may dislodge and be ingested if chewed excessively.

    Product
    Big Burst Blue Raspberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2014·2013-11-27

    Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling 43,840 GemStar infusion pumps worldwide because pressure sensor calibration drift may cause the device to fail occlusion tests or issue false alarms.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Food)·F-0200-2014·2013-11-27

    American Beverage Corp Recalls Big Juicy Orange Drink Due to Cap Hazard

    American Beverage Corp is recalling Big Juicy Orange Drink in 10 oz plastic bottles because the nozzle cap may dislodge if chewed, posing a health hazard.

    Product
    Big Juicy Orange Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0196-2014·2013-11-27

    Guzzler Orchard Chill bottles recalled due to potential cap dislodgement hazard

    American Beverage Corp is recalling Guzzler Orchard Chill bottles because the nozzle cap may dislodge if chewed, posing a choking or ingestion risk.

    Product
    Guzzler Orchard Chill, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1650 system software due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0223-2014·2013-11-27

    Sunny Pine Farm Recalls Organic Chevre Due to Pasteurization Concerns

    Sunny Pine Farm is voluntarily recalling Organic Chevre sold in Washington due to possible improper pasteurization.

    Product
    Organic Chevre sold at Farmer's Market in plastic 6 oz tubs, vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Product also sold to in 2 lbs. and 3 lbs. to restaurant. Product is labeled in parts: "***Organic Goat Dairy***Chevre***SUNNY PINE FARM***6 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0343-2014·2013-11-27

    Siemens ADVIA 1200 Software Recalled for Ration Parameter Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1200 System Software versions 2.00 and 2.01 due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2014·2013-11-27

    GE Healthcare Recalls SPECT Imaging Systems Due to Potential Patient Contact Hazard

    GE Healthcare is recalling four models of nuclear medicine and CT imaging systems because the detector may contact a patient's elbow during specific SPECT scans.

    Product
    GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ functio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2014·2013-11-27

    Philips Brilliance iCT CT Scanner Recall for Footrest Contact Hazard

    Philips is recalling nine Brilliance iCT CT scanners because the footrest extension can contact the gantry or user during operation.

    Product
    Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray 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-0342-2014·2013-11-27

    Trumpf TruSystem Surgical Table Leg Section Recall for Detachment Risk

    Trumpf Medical Systems is recalling 15 TruSystem Surgical Table Leg Section One Part Light components because the coupler point may detach from the frame.

    Product
    TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the u
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0216-2014·2013-11-27

    Flex Dietary Supplement Recalled for Undeclared Shark Cartilage

    New Algae Company is recalling Flex dietary supplement bottles because the label fails to declare shark cartilage, a potential allergen.

    Product
    Flex, Maximum Flexibility, Item number 21-601, dietary supplement, 90 capsules per bottle. The Flex product is a dietary supplement in capsule form containing vegetable glucosamine HCL, chondroitin sulfate (shark cartilage), organic microalgae (aph. flos-aquae) and chicken ca
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0225-2014·2013-11-27

    Sunny Pine Farm Recalls Organic Honey Lavender Chevre for Pasteurization Concerns

    Sunny Pine Farm is voluntarily recalling Organic Honey Lavender Chevre due to possible improper pasteurization. The product was sold in Washington state.

    Product
    Organic Honey Lavender Chevre is sold in plastic 6 oz tubs under Sunny Pine Farm brand. The product is labeled in parts: "***Organic Goat Dairy***Honey Lavender Chevre***6 oz.***SUNNY PINE FARM***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Honey, Sa
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0189-2014·2013-11-27

    American Beverage Corp. Recalls Big Hug Fruit Barrel Orange Bottles

    American Beverage Corp. is recalling Big Hug Fruit Barrel Orange bottles due to a potential risk of nozzle cap parts becoming dislodged and ingested.

    Product
    Big Hug, Fruit Barrel Orange in a plastic 16 oz bottle with a sports cap, American Beverage Corp., Verona, PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0208-2014·2013-11-27

    American Beverage Corp. Recalls Big Hug Fruit Barrel Blue Raspberry Bottles

    American Beverage Corp. is recalling Big Hug Fruit Barrel Blue Raspberry bottles due to a potential choking hazard from the sports cap.

    Product
    Big Hug Fruit Barrel Blue Raspberry in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0191-2014·2013-11-27

    Guzzler Concord Grape Beverage Recalled for Potential Cap Fragment Ingestion

    American Beverage Corp is recalling Guzzler Concord Grape beverages because a part of the nozzle cap may dislodge and be ingested.

    Product
    Guzzler Concord Grape 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0190-2014·2013-11-27

    Guzzler Lemonade Recalled for Potential Ingestion of Dislodged Bottle Cap Parts

    American Beverage Corp is recalling Guzzler Lemonade 20 fl. oz. bottles due to a risk that nozzle cap parts may dislodge and be ingested.

    Product
    Guzzler Lemonade 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Parameter Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1800 System Software V2.01 due to ration parameters flagging behavior issues.

    Product
    ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2014·2013-11-27

    Zeiss IOLMaster Recalled for Incorrect Lens Database Value

    Carl Zeiss Meditec is recalling 4,907 IOLMaster devices because an incorrect lens constant in the internal database could lead to the implantation of intraocular lenses with the wrong power.

    Product
    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primari
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slide Dispense cartridges due to slide dispense issues.

    Product
    VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 81,382 units distributed worldwide.

    Product
    VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0365-2014·2013-11-27

    Siemens Chemistry Calibrator Recall for Direct Bilirubin Assay Shift

    Siemens is recalling Chemistry Calibrators for the Direct Bilirubin Assay because reassigned System Specific Values may cause an average shift in results.

    Product
    Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of dir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0360-2014·2013-11-27

    Salter Labs Recalls CO2 Sample Lines Due to Incorrect Length

    Salter Labs is recalling specific lots of 15-foot CO2 sample lines because they may contain 30-foot tubes instead.

    Product
    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0296-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS ALKP Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS ALKP Slides because of slide dispense issues. The recall affects 183,267 units distributed worldwide.

    Product
    VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0353-2014·2013-11-27

    Restoration Robotics Recalls Epsilon Skin Tensioner Due to Pin Discoloration

    Restoration Robotics is recalling Epsilon Skin Tensioner devices because stainless steel pins may have discoloration from insufficient cleaning during passivation.

    Product
    Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicul
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0376-2014·2013-11-27

    Ivoclar Vivadent Recalls ExciTE F DSC Dental Adhesive Due to Discoloration

    Ivoclar Vivadent is recalling ExciTE F DSC Dental Adhesive because it produces blue-green discoloration when used with cements.

    Product
    ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-006-2014·2013-11-27

    L. Perrigo Recalls Infants' Acetaminophen Due to Unmarked Dosing Syringes

    L. Perrigo is recalling 108,828 bottles of infants' acetaminophen because some cartons may contain dosing syringes without dose markings.

    Product
    EQUATE PAIN AND FEVER — EQUATE PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2014·2013-11-27

    Restoration Robotics Recalls Sterile Disposable Kits Due to Pin Discoloration

    Restoration Robotics is recalling sterile disposable kits used in hair restoration because skin tensioner pins have discoloration from insufficient cleaning.

    Product
    Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting dur
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2013.