The Recall Desk

Archive

January 2016 recalls

400 recalls were announced in January 2016.

What the numbers show

Critical
14
Severe
111
High
159
Moderate
107
Low
9

Of the 400 recalls this month scored against our rubric, 4% are Critical, 28% are Severe.

101–200 of 400

  • HighCPSC·16081·2016-01-21

    Britax Recalls B-Safe 35 Infant Car Seats Due to Handle Crack Hazard

    Britax is recalling about 71,000 B-Safe 35 infant car seats because the carry handle can crack and break, posing a fall hazard to infants.

    Product
    Britax B-Safe 35 and B-Safe 35 Elite infant car seats and travel systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·007-2016·2016-01-20

    Snapp's Ferry Packing Recalls Beef Product Due To Possible E. Coli O157:H7

    Snapp's Ferry Packing Company is recalling approximately 410 pounds of ground beef that may be contaminated with E. coli O157:H7.

    Product
    SAN Meat Packing Inc. — Snapp's Ferry Packing Company Recalls Beef Product Due To Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0469-2016·2016-01-20

    Sweet Superior Recalls Jalapenos Tested Positive for Salmonella

    Sweet Superior Ltd is recalling PICOSITO Jalapenos distributed in Texas and Illinois because the product tested positive for Salmonella.

    Product
    PICOSITO Jalapenos Distributed by: Sweet Superior Fruit LTD. CO. PRODUCE OF MEXICO
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0503-2016·2016-01-20

    Nestle Recalls Sweet Leaf Lemonade Tea Due to Glass Particles

    Nestle Waters North America is recalling Sweet Leaf Organic Half and Half Lemonade Tea because the product contains glass particles.

    Product
    Sweet Leaf Organic Half and Half Lemonade Tea, 16 oz glass bottle UPC: 6-51538-06708-1
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0368-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Sockeye Cans for Botulism Risk

    Sockeye Suzys Fish LLC is recalling 13,281 cans of smoked sockeye in Oregon and Washington due to potential Clostridium botulinum contamination.

    Product
    Smoked Sockeye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67242 1
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0360-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Chinook Salmon Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of smoked Chinook salmon in Oregon and Washington due to potential Clostridium botulinum contamination.

    Product
    Smoked Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67282 7
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0367-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Jalapeno Steelhead Due to Botulism Risk

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Smoked Jalapeno Steelhead in Oregon and Washington due to potential Clostridium botulinum contamination.

    Product
    Smoked Jalapeno Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67352 7
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0362-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Garlic Chinook Salmon Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Smoked Garlic Chinook Salmon due to potential Clostridium botulinum contamination.

    Product
    Smoked Garlic Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67222 3
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0361-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Coho Salmon Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of smoked coho salmon due to potential Clostridium botulinum contamination.

    Product
    Smoked Coho (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67222 3
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0363-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Garlic Steelhead Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Smoked Garlic Steelhead due to potential Clostridium botulinum contamination. The product was distributed in Oregon and Washington.

    Product
    Smoked Garlic Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67362 6
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0357-2016·2016-01-20

    Sockeye Suzy Fish Recalls Peppered Smoked Steelhead Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Peppered & Smoked Steelhead due to potential Clostridium botulinum contamination.

    Product
    Peppered & Smoked Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67332 9
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0356-2016·2016-01-20

    Sockeye Suzy Fish Recalls Peppered and Smoked Coho Salmon Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Peppered & Smoked Coho Salmon due to potential Clostridium botulinum contamination.

    Product
    Peppered & Smoked Coho (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67212 4
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0355-2016·2016-01-20

    Sockeye Suzy Fish Recalls Peppered and Smoked Chinook Salmon Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Peppered & Smoked Chinook salmon due to potential Clostridium botulinum contamination.

    Product
    Peppered & Smoked Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67282 7 and 7 48252 67302 2.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0370-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Steelhead Due to Botulism Risk

    Sockeye Suzys Fish LLC is recalling 13,281 cans of smoked steelhead in Oregon and Washington due to potential Clostridium botulinum contamination.

    Product
    Smoked Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67342 8
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0371-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Sturgeon Cans Due to Botulism Risk

    Sockeye Suzys Fish LLC is recalling 13,281 cans of smoked sturgeon in Oregon and Washington due to potential Clostridium botulinum contamination.

    Product
    Smoked Sturgeon, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67262 9
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0364-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Jalapeno Chinook Salmon Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of smoked jalapeno Chinook salmon due to potential Clostridium botulinum contamination.

    Product
    Smoked Jalapeno Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67312 1
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0358-2016·2016-01-20

    Sockeye Suzy Fish Recalls Peppered and Smoked Sockeye Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Peppered & Smoked Sockeye due to potential Clostridium botulinum contamination.

    Product
    Peppered & Smoked Sockeye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67232 2
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0504-2016·2016-01-20

    Sweet Leaf Organic Sweet Tea Recalled for Glass Particles

    Nestle Waters North America is recalling Sweet Leaf Organic Original Sweet Tea because the product contains glass particles.

    Product
    Sweet Leaf Organic Original Sweet Tea, 16 oz glass bottle UPC: 6-51538-06700-5
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V020000·2016-01-20

    MCI Recalls Buses Due to Potential Seat Belt Anchor Weld Defects

    Motor Coach Industries is recalling specific MCI buses because missing welds on driver seat brackets could allow seat belt anchors to separate, increasing injury risk in a crash.

    Product
    MCI — MCI D4000, D4500, J4500, D4505
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0365-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Jalapeno Spring Chinook Salmon Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of smoked jalapeno spring Chinook salmon due to potential Clostridium botulinum contamination.

    Product
    Smoked Jalapeno Spring Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67392 3
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0366-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Jalapeno Sturgeon Cans

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Smoked Jalapeno Sturgeon due to potential Clostridium botulinum contamination.

    Product
    Smoked Jalapeno Sturgeon, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67272 8
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0359-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Catfish Cans Due to Botulism Risk

    Sockeye Suzys Fish LLC is recalling 13,281 cans of smoked catfish in Oregon and Washington due to potential Clostridium botulinum contamination.

    Product
    Smoked Catfish, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67252 0
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0354-2016·2016-01-20

    Sockeye Suzy Fish Recalls Canned Salmon for Botulism Risk

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Fancy Spring Chinook salmon in Oregon and Washington due to potential Clostridium botulinum contamination.

    Product
    Fancy Spring Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67412 8
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0372-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Walleye Cans Due to Botulism Risk

    Sockeye Suzys Fish LLC is recalling 13,281 cans of smoked walleye in Oregon and Washington due to potential Clostridium botulinum contamination.

    Product
    Smoked Walleye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 94504 39610 2
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0369-2016·2016-01-20

    Sockeye Suzy Fish Recalls Smoked Spring Chinook Cans for Botulism Risk

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Smoked Spring Chinook in Oregon and Washington due to potential Clostridium botulinum contamination.

    Product
    Smoked Spring Chinook, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67402 9, UPC 7 48252 67382 4, UPC 7 48252 67372 5
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0353-2016·2016-01-20

    Sockeye Suzy Fish Recalls Canned Salmon for Botulism Risk

    Sockeye Suzys Fish LLC is recalling 13,281 cans of Fancy Chinook salmon due to potential Clostridium botulinum contamination.

    Product
    Fancy Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67292 6
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0641-2016·2016-01-20

    Ortho-Clinical VITROS 5600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may cause erroneous test results without user notification.

    Product
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16079·2016-01-20

    Cheryl's Jingle Bell Ornaments Recalled for Sharp Metal Edges

    Cheryl & Co. is recalling Jingle Bell ornaments sold by QVC because sharp metal edges on the cutouts pose a laceration hazard.

    Product
    Cheryl's Jingle Bell ornaments with cookies and confections
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2016·2016-01-20

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

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2016·2016-01-20

    Skytron Ergon 2 Monitor Brackets Recalled Due to Hardware Failure Risk

    Skytron is recalling 286 Ergon 2 monitor brackets because hardware may fail, causing displays to fall and potentially injure patients or providers.

    Product
    Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment penda
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Drugs)·D-0565-2016·2016-01-20

    Amerisource Recalls Hydrochlorothiazide Capsules Due to Particulate Matter

    Amerisource Health Services is recalling specific lots of Hydrochlorothiazide capsules because they contain particulate matter.

    Product
    HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0624-2016·2016-01-20

    Nipro Medical Recalls Hemodialysis Blood Tubing Sets Due to Foaming

    Nipro Medical Corporation is recalling 1,484 disposable hemodialysis blood tubing sets because blood foaming was found during product evaluation.

    Product
    NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0626-2016·2016-01-20

    Encore Medical Recalls AltiVate Reverse Humeral Broach Due to Undersized Feature

    Encore Medical is recalling 23 AltiVate Reverse Humeral Broaches because the trial shell mating feature is undersized. The instruments are used with Encore Shoulder prostheses.

    Product
    AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0652-2016·2016-01-20

    Intuitive Surgical Recalls da Vinci Xi 8mm Endoscopes for Safety Manual Correction

    Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to prevent unintended patient harm from capacitive coupling when using 8mm endoscopes with specific instruments.

    Product
    0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0505-2016·2016-01-20

    Nestle Recalls Sweet Leaf Citrus Green Tea Due to Glass Particles

    Nestle Waters North America is recalling Sweet Leaf All Natural Citrus Green Tea because the product contains glass particles.

    Product
    Sweet Leaf All Natural Citrus Green Tea, 16 oz glass bottle UPC: 6-51538-06720-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2016·2016-01-20

    Brainlab RT Elements software recall for image cropping defect

    Brainlab AG is recalling RT Elements software because large objects may display cropped during import, potentially affecting radiation treatment planning.

    Product
    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0639-2016·2016-01-20

    Mercury Medical Recalls Neo-Tee T-Piece Resuscitators Due to Occlusion Risk

    Mercury Medical is recalling Neo-Tee T-Piece Resuscitators and circuits because incorrect use can cause complete circuit occlusion, leading to failure to ventilate the patient.

    Product
    Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0642-2016·2016-01-20

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0502-2016·2016-01-20

    Sweet Leaf Organic Raspberry Iced Tea Recalled for Glass Particles

    Nestle Waters North America is recalling Sweet Leaf Organic Raspberry Iced Tea because the product contains glass particles.

    Product
    Sweet Leaf Organic Raspberry Iced Tea, 16 oz glass bottle UPC: 6-51538-06703-6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2016·2016-01-20

    Thornhill Research Recalls MOVES Emergency Ventilators Due to Battery Defects

    Thornhill Research Inc. is recalling 83 MOVES System emergency ventilators because the batteries may become unresponsive after storage and remain perpetually enabled.

    Product
    MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ve
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·16V023000·2016-01-20

    Altec Recalls Aerial Devices Due to Hydraulic Valve Defect

    Altec is recalling 2010-2015 AH75, AH85, and AH100 aerial devices because a hydraulic valve may allow unexpected movement, increasing injury risk.

    Product
    ALTEC — ALTEC AH75, AH85, AH100
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E003000·2016-01-20

    GMAX Recalls GM78 Fullface Helmets for Safety Standard Non-Compliance

    GMAX Helmet LLC is recalling specific GM78 Fullface helmets that may not adequately protect users in a crash. Owners can exchange the helmet or receive a refund.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V022000·2016-01-20

    Setra Recalls 2011-2012 Buses Due to Missing Seat Belt Welds

    Setra is recalling 2011-2012 S407CC and S417TC buses because missing welds on seat brackets could cause seat belts to detach during a crash.

    Product
    SETRA — SETRA S407 CC, S417 TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0421-2016·2016-01-20

    Mi Tienda Masa Preparada Recalled for Possible Metal Fragments

    HEB Retail Support Center is recalling Mi Tienda Masa Preparada By the Pound due to the possible presence of metal fragments.

    Product
    Mi Tienda Masa Preparada By the Pound packaged in bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0567-2016·2016-01-20

    Freedom Pharmaceuticals Recalls Domperidone API Due to Penicillin Cross-Contamination

    Freedom Pharmaceuticals is recalling specific lots of Domperidone API for prescription compounding due to potential cross-contamination with penicillin.

    Product
    Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0587-2016·2016-01-20

    Thornhill Research Recalls MOVES System Lithium Polymer Batteries

    Thornhill Research Inc is recalling 178 MOVES System Lithium Polymer Batteries because they may become unresponsive after storage and remain perpetually enabled.

    Product
    MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0653-2016·2016-01-20

    Intuitive Surgical Recalls da Vinci Xi Endoscopes for Capacitive Coupling Risk

    Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to warn about unintended patient harm from capacitive coupling when using 8 mm endoscopes with specific instruments.

    Product
    30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2016·2016-01-20

    CompView NuCARTGN Medical Display Recall Due to Spring Arm Detachment Risk

    CompView Medical is recalling 10 NuCARTGN mobile display units because the spring arm may detach if the securing ring was not installed correctly.

    Product
    Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0507-2016·2016-01-20

    Nestle Recalls Sweet Leaf Organic Tea Mint & Honey Due to Glass Particles

    Nestle Waters North America is recalling Sweet Leaf Organic Tea Mint & Honey because the product contains glass particles.

    Product
    Sweet Leaf Organic Tea Mint & Honey, 16 oz glass bottle UPC: 6-51538-06701-2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0422-2016·2016-01-20

    Mi Tienda Tostada Siveria Large Tostada Recalled for Metal Fragments

    HEB Retail Support Center is recalling Mi Tienda Tostada Siveria Large Tostada due to possible metal fragments. The product was sold in Texas.

    Product
    Mi Tienda Tostada Siveria Large Tostada packaged in bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0506-2016·2016-01-20

    Nestle Recalls Sweet Leaf Peach Iced Tea Due to Glass Particles

    Nestle Waters North America is recalling Sweet Leaf All Natural Peach Iced Tea because the product contains glass particles.

    Product
    Sweet Leaf All Natural Peach Iced Tea , 16 oz glass bottle UPC: 6-51538-06704-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0485-2016·2016-01-20

    Garden Harvest Recalls House MADE Sriracha Sauce for Unlicensed Manufacturing

    Garden Harvest is recalling House MADE Sriracha Sauce because the firm was manufacturing acidified foods without a license.

    Product
    House MADE Sriracha Sauce NET WT. 8 oz (237 mL) INGREDIENTS: THAI CHILIES, DISTILLED VINEGAR, SUGARS, GARLIC, MOLASSES, KOSHER SALT. www.housemadesriracha.com UPC 6 12524 99999 1
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0627-2016·2016-01-20

    Bayer Recalls Medrad Source Administration Sets for Dosing Errors

    Bayer Healthcare is recalling Medrad Source Administration Sets because tubing defects may cause incorrect dose positioning during nuclear medicine procedures.

    Product
    Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0623-2016·2016-01-20

    ArthroCare Cavity 8 Gauge Spine Wand Recalled for Sterile Barrier Failure

    ArthroCare Corporation is recalling 262 Cavity 8 Gauge Spine Wands because cracking in the tray compromises the sterile barrier.

    Product
    Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2016·2016-01-20

    Ortho-Clinical VITROS 3600 Chemistry System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Chemistry Systems due to a software anomaly that may allow the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2016·2016-01-20

    OrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect

    OrthoPediatrics Corp is recalling 102 Response Spine UniAxial Pedicle Screws because they may have been manufactured incorrectly, preventing the driver from fully engaging the screw.

    Product
    UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative d
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0625-2016·2016-01-20

    Zimmer Biomet Recalls Virage OCT Spinal Fixation System Due to Set Screw Defect

    Zimmer Biomet is recalling the Virage OCT Spinal Fixation System because set screw staking is out of specification, which can interfere with rod insertion.

    Product
    Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Food)·F-0472-2016·2016-01-20

    Garden Harvest Recalls Unlicensed Acidified Salsa Products

    Garden Harvest is recalling 64 cases of A Bit of a Bite Salsa Sarah Sweet because the firm was manufacturing acidified foods without a license.

    Product
    A BIT OF A BITE SALSA SARAH SWEET NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95417 4
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0484-2016·2016-01-20

    Garden Harvest Recalls Herbert's Chow-Chow Due to Unlicensed Acidified Food Production

    Garden Harvest is recalling Herbert's chow-chow because the firm was manufacturing acidified foods without a license. The product was distributed to Ohio, Florida, and West Virginia.

    Product
    HERBERT'S chow-chow Original New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0495-2016·2016-01-20

    Garden Harvest Recalls Patty's Peppers for Unlicensed Acidified Food Manufacturing

    Garden Harvest is recalling Patty's Peppers Hungarian Hot & Sweet Peppers because the firm was manufacturing acidified foods without a license.

    Product
    PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Uncle Joe's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot Wax Peppers, Garlic, Vinegar, All Natural Ketchup, Sugar, Canola Oil, pattyspeppers.com UPC 7 48252 07486 7
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0479-2016·2016-01-20

    Garden Harvest Recalls Cleveland Pickle Garlic Dill for Unlicensed Manufacturing

    Garden Harvest is recalling 146 cases of Cleveland Pickle Original Garlic Dill because the firm was manufacturing acidified foods without a license.

    Product
    Cleveland Pickle Original Garlic Dill 16 oz (454 g) Ingredients: Cucumbers, Water***Manufactured For: CLEVELAND PICKLE 850 EUCLID AVE. CLEVELAND OH 44114 216-575-1111 UPC 8 67051 00001 0
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0489-2016·2016-01-20

    Keim's Garden Harvest Pickled White Eggs Recalled for Unlicensed Manufacturing

    Garden Harvest is recalling pickled white eggs because the firm was manufacturing acidified foods without a license.

    Product
    Keim's Garden Harvest pickled white eggs Ingredients: eggs, water, vinegar, sugar, salt. Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83461 8, 32 oz 6 09788 83456 4
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0509-2016·2016-01-20

    Snack Depot Recalls Mislabeled Roasted Seasoned Himego Fish

    Snack Depot is recalling Roasted Seasoned Himego Fish (spicy) because the product was mislabeled and misidentified. The recall covers 30 cases distributed in California.

    Product
    Roasted Seasoned Himego Fish (spicy) Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0635-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 47 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0498-2016·2016-01-20

    Garden Harvest Recalls Roasted Mediterranean Pepper Relish for Unlicensed Manufacturing

    Garden Harvest is recalling 153 cases of Roasted Mediterranean Pepper Relish because the firm was manufacturing acidified foods without a license.

    Product
    ROASTED MEDITERRANEAN PEPPER RELISH 16 Fl Oz (355 ml) MANUFACTURED FOR RUST BELT PEPPER CO P.O. BOX 36014 CANTON, OHIO 44718 330.323-4735 INGREDIENTS: Imported Roasted Red Peppers***UPC 8 11975 01109 6
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0475-2016·2016-01-20

    Garden Harvest Recalls Barney's Hot Peppers Due to Unlicensed Manufacturing

    Garden Harvest is recalling 106 cases of Barney's Hot Peppers because the firm was manufacturing acidified foods without a license.

    Product
    Barney's Hot Peppers 16 oz (443 ml) Ingredients: Hot Peppers, Canola Oil, Garlic, Oregano, Salt, Acidic Calcium Sulfate Distributed by: Barney's Hot Peppers 2061 Elm Road Warren, Ohio 44483 330-964-2922 UPC # 7 01807 99994 7
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0490-2016·2016-01-20

    Keim's Garden Harvest Pickled Eggs Recalled for Unlicensed Manufacturing

    Keim's Garden Harvest is recalling pickled zesty mustard eggs because the firm was manufacturing acidified foods without a license.

    Product
    Keim's Garden Harvest pickled zesty mustard eggs Ingredients: eggs, water, vinegar, sugar, salt***yellow #5, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83464 9, 32 oz 6 09788 83459 5
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0638-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 188 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0621-2016·2016-01-20

    Boston Scientific Recalls Three Pacemakers Due to Incorrect Literature Packet

    Boston Scientific is recalling three PROPONENT MRI DR pacemakers because the included literature packet incorrectly describes the device type.

    Product
    Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0637-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 22 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0629-2016·2016-01-20

    Stryker Tourniquet Cuffs Recalled for Mislabeling Port Configuration

    Stryker is recalling 450 reprocessed tourniquet cuffs because they were mislabeled regarding their port configuration.

    Product
    Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0470-2016·2016-01-20

    Garden Harvest Recalls Heiney Hot Salsa for Unlicensed Acidified Food Production

    Garden Harvest is recalling 26 cases of Heiney Hot Salsa because the firm was manufacturing acidified foods without a license.

    Product
    A BIT OF A BITE SALSA HEINEY HOT SALSA NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95415 0
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0634-2016·2016-01-20

    Perkin Elmer ClWIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 62 ClWIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0646-2016·2016-01-20

    Zimmer Biomet Recalls Mislabeled Periarticular Locking Plate System Screws

    Zimmer Biomet is recalling 400 units of Periarticular Locking Plate System screws because the package labels did not match the product contents.

    Product
    Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-0473-2016·2016-01-20

    Garden Harvest Recalls Unlicensed Acidified Salsa Products

    Garden Harvest is recalling 52 cases of A Bit of a Bite Salsa Three Sisters because the firm was manufacturing acidified foods without a license.

    Product
    A BIT OF A BITE SALSA THREE SISTERS NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, ORGANIC BLACK BEANS, FRESH CORN***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95418 1
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0491-2016·2016-01-20

    Garden Harvest Black Bean Salsa Recalled for Unlicensed Acidified Food Production

    Garden Harvest is recalling 41 cases of black bean salsa because the firm was manufacturing acidified foods without a license.

    Product
    Kiem's Garden Harvest black bean salsa 1 PT (14 oz 397g) Ingredients: beans, corn, tomato***Manufactured by: Keim's Garden Harvest (937) 515-4518 Honeysuckle Lane Wellston, OH UPC 6 09722 32347 5
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0482-2016·2016-01-20

    Garden Harvest Recalls Herbert's Chow-Chow for Unlicensed Acidified Food Production

    Garden Harvest is recalling 156 cases of Herbert's chow-chow because the firm was manufacturing acidified foods without a license.

    Product
    HERBERT'S chow-chow Hot New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0492-2016·2016-01-20

    Garden Harvest corn relish recalled for unlicensed acidified food production

    Garden Harvest is recalling corn relish because the firm was manufacturing acidified foods without a license.

    Product
    Kiem's Garden Harvest corn relish 1 PT (14 oz 397g) Ingredients: corn, peppers, celery***Manufactured by: Keim's Garden Harvest (937) 515-4518 Honeysuckle Lane Wellston, OH 45692 Mild UPC 6 09722 32335 2 Hot UPC 6 09722 32349 9
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0494-2016·2016-01-20

    Garden Harvest Recalls Patty's Peppers for Unlicensed Acidified Food Production

    Garden Harvest is recalling Patty's Peppers Hungarian Hot & Sweet Peppers because the firm was manufacturing acidified foods without a license.

    Product
    PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Mom's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot and Sweet Peppers, Garlic, Canola Oil, Vinegar, Salt, Oregano. pattspeppers.com UPC 7 48252 07478 2
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0480-2016·2016-01-20

    Garden Harvest Recalls Unlicensed Cleveland Pickle Spicy Garlic Dill

    Garden Harvest is recalling 160 cases of Cleveland Pickle Spicy Garlic Dill because the firm was manufacturing acidified foods without a license.

    Product
    Cleveland Pickle Spicy Garlic Dill 16 oz (454 g) Ingredients: Cucumbers, Water***Habanero Peppers***Manufactured For: CLEVELAND PICKLE 850 EUCLID AVE. CLEVELAND OH 44114 216-575-1111 UPC 8 67051 00001 0
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0488-2016·2016-01-20

    Keim's Garden Harvest Pickled Red Beet Eggs Recalled for Unlicensed Manufacturing

    Keim's Garden Harvest is recalling pickled red beet eggs because the firm was manufacturing acidified foods without a license.

    Product
    Keim's Garden Harvest pickled red beet eggs Ingredients: eggs, water, vinegar, sugar, salt***beet juice, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83455 7, 32 oz 6 09788 83457 4
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0649-2016·2016-01-20

    Beckman Coulter Recalls iChem 10 SG Urine Chemistry Strips

    Beckman Coulter is recalling iChem 10 SG Urine Chemistry Strips because they may produce false positive leukocyte results for negative samples.

    Product
    iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0633-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error

    Perkinelmer is recalling 60 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, leading to erroneous results.

    Product
    Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0628-2016·2016-01-20

    BD Biosciences Recalls FMC7 FITC Reagent Due to Functional Degradation

    Becton, Dickinson and Company is recalling FMC7 FITC reagents because functional degradation reduces the percent positive from 100% to approximately 87%.

    Product
    FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Incorrect Barcode Label

    Perkinelmer is recalling four WIZARD2 gamma counters because a barcode label misidentifies sample ID #023 as #024, which may cause the device to execute the wrong measurement protocol and produce erroneous results.

    Product
    Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0477-2016·2016-01-20

    Garden Harvest Recalls Bino's Italian Sweet Peppers Due to Unlicensed Manufacturing

    Garden Harvest is recalling Bino's Italian Sweet Peppers because the firm was manufacturing acidified foods without a license. The product was shipped to Ohio, Florida, and West Virginia.

    Product
    BINO'S ITALIAN SWEET PEPPERS Ingredients: Bell peppers, onions, vinegar, garlic, sugar, tomato sauce, tomato puree, salt and olive oil. NET WT 16 oz UPC 8 67752 00012 8 NET WT 32 oz UPC 8 67752 00010 4
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0478-2016·2016-01-20

    Garden Harvest Recalls Cafe 422 Hot Peppers in Oil for Unlicensed Manufacturing

    Garden Harvest is recalling 136 cases of Cafe 422 Hot Peppers in Oil because the firm was manufacturing acidified foods without a license. The product was distributed in Ohio, Florida, and West Virginia.

    Product
    Cafe 422 HOT PEPPERS in oil INGREDIENTS Hungarian Hot Peppers***Manufactured & Hand Packed by: Caf¿ 422 4422 Youngstown Rd SE Warren, Ohio 44484 330.369.2422 16 oz UPC 8 60557 00010 2 & 32 oz UPC 8 60557 00011 9
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0481-2016·2016-01-20

    Garden Harvest Recalls Pickled Beets Manufactured Without License

    Garden Harvest is recalling Dutch Country Kettles Homemade Pickled Beets because the firm was manufacturing acidified foods without a license.

    Product
    DUTCH COUNTRY KETTLES HOMEMADE Pickled Beets Ingredients: Beets, Water, Vinegar, Sugar, Salt. Dutch Country Kettles 6732 Pavey Road. Leesburg, OH 45135 1-937-780-6718 1 Pint (1 lb. 3oz) 538g UPC 6 98241 12224 9 & 1 Quart (32 oz) 907g UPC 6 98241 14444 9
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0650-2016·2016-01-20

    Biomet Hip Stem Recall for Incorrect PMMA Labeling

    Biomet is recalling 21 hip stem implants because the label incorrectly lists PMMA as a material, though the product does not contain it.

    Product
    Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0493-2016·2016-01-20

    Garden Harvest Citrus Salsa Recalled for Unlicensed Acidified Food Production

    Garden Harvest is recalling 80 cases of sweet & tangy citrus salsa because the firm was manufacturing acidified foods without a license.

    Product
    Kiem's Garden Harvest sweet & tangy citrus salsa 1 PT (14 oz 397g) Ingredients:tomatoes, onions***lemon juice concentrate, lime juice concentrate***Manufactured by: Keim's Garden Harvest (937) 515-4518 2232 Honeysuckle Lane Wellston, OH 45692 UPC 6 09722 32346 8
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0487-2016·2016-01-20

    Keim's Garden Harvest Pickled Beets Recalled for Unlicensed Manufacturing

    Keim's Garden Harvest pickled beets are being recalled because the manufacturer was producing acidified foods without a required license.

    Product
    Keim's Garden Harvest pickled beets Ingredients: red beets, water, sugar, vinegar, spices, salt. Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 14 oz UPC 6 09722 32336 9, 32 oz UPC 6 09722 32339 0
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0499-2016·2016-01-20

    Garden Harvest Recalls Roasted Mediterranean Spicy Pepper Relish for Unlicensed Production

    Garden Harvest is recalling 143 cases of Roasted Mediterranean Spicy Pepper Relish because the firm was manufacturing acidified foods without a license.

    Product
    ROASTED MEDITERRANEAN SPICY PEPPER RELISH 16 Fl Oz (355 ml) MANUFACTURED FOR RUST BELT PEPPER CO P.O. BOX 36014 CANTON, OHIO 44718 330.323-4735 INGREDIENTS: Imported Roasted Red Peppers***Habanero Pepper. UPC 8 63131 00011 6
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0497-2016·2016-01-20

    Garden Harvest Recalls RJ's Peppers in Oil for Unlicensed Manufacturing

    Garden Harvest is recalling RJ's Peppers in Oil because the firm was manufacturing acidified foods without a license.

    Product
    RJ's PEPPERS IN OIL 12 OZ. (340G) INGREDIENTS: PEPPERS, CANOLA OIL***Manufactured for: RJ's Pepper Pantry Warren, OH 4484 Phone: 330-766-2863 Mild UPC 8 53827 00401 6, Medium Hot UPC 8 53827 00402 3, Hot UPC 8 53827 00400 9
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0508-2016·2016-01-20

    Snack Depot Recalls Mislabeled Roasted Seasoned Himego Fish Fillets

    Snack Depot, Inc. is recalling 30 cases of Roasted Seasoned Himego Fish because the product was mislabeled and misidentified. The recall is limited to California.

    Product
    Roasted Seasoned Himego Fish Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0483-2016·2016-01-20

    Garden Harvest Recalls Herbert's Chow-Chow Due to Unlicensed Manufacturing

    Garden Harvest is recalling specific lots of Herbert's chow-chow because the firm was manufacturing acidified foods without a license.

    Product
    HERBERT'S chow-chow Mild New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0568-2016·2016-01-20

    Life-Line Docusate Calcium Stool Softener Recalled for Labeling Error

    National Vitamin Co Inc is recalling Life-Line Docusate Calcium stool softeners because they were mislabeled as Docusate Sodium.

    Product
    Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0647-2016·2016-01-20

    Brainlab Brain Metastases Software Recall for Image Display Errors

    Brainlab AG is recalling Brain Metastases 1.0.0 software because large objects may display cropped during import.

    Product
    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0500-2016·2016-01-20

    Garden Harvest Recalls Sugar & Spice Gourmet Beets for Unlicensed Manufacturing

    Garden Harvest is recalling 50 cases of Sugar & Spice Gourmet Beets because the firm was manufacturing acidified foods without a license.

    Product
    SEASONAL SELECTIONS SUGAR & SPICE GOURMET BEETS NET WT 16 OZ (1 lb) 453g INGREDIENTS: Beets, Vinegar, Sugar, Whole Allspice, Salt, Cinnamon Sticks SEASONAL SELECTIONS P.O. BOX 251 Waynesville, OH 45060 UPC 8 57596 00308 9
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0474-2016·2016-01-20

    Garden Harvest Recalls Abruzzi's Hot Peppers in Oil for Unlicensed Manufacturing

    Garden Harvest is recalling 1,143 cases of Abruzzi's Hot Peppers in Oil because the firm was manufacturing acidified foods without a license.

    Product
    Abruzzi's Hot Peppers in oil 15 Fl Oz (444 ml) Manufactured For: Abruzzis Hot Peppers, LLC, 371 Marwood Drive, S.E. Warren, Ohio 44484 (330) 883-7933 UPC 8 51071 00500 1
    Category
    Food
    Distribution
    3 states

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