The Recall Desk

Archive

May 2017 recalls

771 recalls were announced in May 2017.

What the numbers show

Critical
45
Severe
174
High
254
Moderate
259
Low
39

Of the 771 recalls this month scored against our rubric, 6% are Critical, 23% are Severe.

401–500 of 771

  • HighFDA (Food)·F-2189-2017·2017-05-17

    Givaudan Recalls Chili Seasoning Due to Potential Salmonella Contamination

    Givaudan Flavours Corp is recalling 50 lb bags of Chili Seasoning because an ingredient may contain Salmonella. The product was distributed to Illinois, Ohio, and Missouri.

    Product
    Chili Seasoning 50 lbs INGREDIENTS: Chili Pepper, Minced Onion, Wheat Flour***CONTAINS: WHEAT spicetec¿ FLAVORS & SEASONINGS 195 Alexandra Way Carol Stream, IL 60188 (630) 582-5608
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0700-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 7.5 mg, because they failed impurity specifications. The recall covers 6,138 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceut
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2057-2017·2017-05-17

    Med-Hot Thermal Imaging System Recalled for Lack of FDA Clearance

    Med-Hot Thermal Imaging, Inc. is recalling 12 units of the MTI 2000 Thermal Imaging System because the indications for use are not cleared or approved for the U.S. market.

    Product
    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0702-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 20 mg, because they failed impurity specifications. The recall covers 14,784 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Olanzapine Tablets, 2.5 mg, because they failed impurity specifications.

    Product
    Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2059-2017·2017-05-17

    Zimmer Biomet Recalls Mislabeled Bone Dowell Harvest Tubes

    Zimmer Biomet is recalling 49 Bone Dowell Harvest Tubes that were mislabeled as 8mm but are actually 9mm in size.

    Product
    Bone Dowell Harvest Tubes
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2036-2017·2017-05-17

    Smith & Nephew Recalls Mislabelled Peri-Loc Volar Distal Radius Plates

    Smith & Nephew is recalling 12 units of Peri-Loc Volar Distal Radius plates that were laser-etched as left plates but packaged as right plates.

    Product
    PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2208-2017·2017-05-17

    Vertical Pharmaceuticals Recalls OB Complete Prenatal Multivitamin Due to Labeling Error

    Vertical Pharmaceuticals is recalling one lot of OB Complete with DHA Prenatal Multivitamin because the label claim for Omega-3 Fatty Acids does not match the actual formulation.

    Product
    Vertical Pharmaceuticals OB Complete with DHA Prenatal Multivitamin, 60 softgels Rx Only, Manufactured for: Vertical Pharmaceuticals, LLC Sayreville, NJ 08872 UPC 368025049603
    Category
    Food
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2056-2017·2017-05-17

    Zimmer Biomet Recalls Cobalt Bone Cement Due to Packaging Seal Issues

    Zimmer Biomet is recalling specific lots of Cobalt bone cement because a breach in the sterile Tyvek packaging could lead to loss of sterility.

    Product
    Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2047-2017·2017-05-17

    Medtronic PAK Needle Beveled and Trocar Tips Recalled for Packaging Error

    Medtronic is recalling 36 units of PAK Needle Beveled and Trocar Tips because packaging may contain incorrect needle types instead of the required combination.

    Product
    Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2071-2017·2017-05-17

    Stryker PROFESS Registration Kit Recalled for Expiration Date Issues

    Stryker is recalling 65 PROFESS Registration Kits shipped near or past their expiration dates. The kits are used for intranasal and sinus surgery.

    Product
    Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2054-2017·2017-05-17

    CooperSurgical lnflatoball Pessary Recalled for Incorrect Latex-Free Labeling

    CooperSurgical is recalling lnflatoball Latex Rubber Pessaries because the secondary packaging incorrectly states the product is latex-free, despite being made of 100% latex.

    Product
    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2048-2017·2017-05-17

    Zimmer CAS Recalls NDI P7 Position Sensors for Potential Malfunction

    Zimmer CAS is recalling 34 NDI P7 Position Sensors due to a manufacturing issue that may cause them to stop functioning during use.

    Product
    NDI P7 Position Sensor, Stereotaxic Instrument
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2069-2017·2017-05-17

    Almore Microfil Composite Instruments Recalled for Incorrect Sterile Labeling

    Almore International Inc. is recalling Microfil Composite Instruments because packaging labels incorrectly display a sterile symbol, although the devices are not sterile.

    Product
    Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin paddles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2040-2017·2017-05-17

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Patient ID Error

    Siemens is recalling 159 RAPIDPoint 500 Blood Gas Analyzers because a blank patient ID field may cause demographic errors.

    Product
    RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0697-2017·2017-05-17

    Akorn Recalls IC-Green Injection Kits Due to Low pH Value

    Akorn, Inc. is recalling 1,292 kits of IC-Green (indocyanine green for injection) due to low pH values. The product was distributed nationwide.

    Product
    IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0703-2017·2017-05-17

    Teva Recalls Prednisolone Oral Solution for Failed Stability Specifications

    Teva Pharmaceuticals USA is recalling specific lots of Prednisolone Oral Solution because they failed stability specifications.

    Product
    PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2070-2017·2017-05-17

    Mentor Breast Implant Recall Due to Missing Dome Pack Accessory

    Mentor Texas, LP. is recalling 28 units of Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implants because the Dome Pack accessory is missing.

    Product
    Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Drugs)·D-0701-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 10 mg, because they failed impurity specifications. The recall covers 38,316 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V323000·2017-05-16

    Nova Bus Recalls 2016 LFS Artic Buses for Throttle Control Defect

    Nova Bus is recalling 2016 LFS Artic transit buses because a network communication loss may cause the computer to apply full throttle without driver input.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V322000·2017-05-16

    Kenworth T800 and T880 Trucks Recalled for Brake Airline Defect

    PACCAR is recalling 2012-2018 Kenworth T800 and T880 trucks because an incorrectly sized brake control airline may increase stopping distance and crash risk.

    Product
    KENWORTH — KENWORTH T880, T800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-051617·2017-05-16

    USDA Issues Alert for Imported Veal Due to E. coli O103 Contamination

    USDA FSIS issued a public health alert for imported raw veal products potentially contaminated with E. coli O103. No illnesses have been reported.

    Product
    FSIS Issues Public Health Alert For Imported Veal Products Due To Possible Non-O157 Shiga toxin producing E. coli (STEC) O103 Contamination
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·17152·2017-05-15

    VanMoof Recalls B and S Series Bicycles Due to Fender Bolt Hazard

    VanMoof is recalling B and S series bicycles because front fender bolts may not break during obstructions, posing fall and impact hazards.

    Product
    VanMoof B and S series bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V320000·2017-05-15

    Terex Aerial Devices and Digger Derricks Recalled for Electrical Shock Risk

    Terex is recalling 2007-2016 aerial devices and digger derricks because the onboard electrical breaker may fail to trip during a short circuit, increasing the risk of user injury.

    Product
    TEREX — TEREX AERIAL DEVICES, DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17E026000·2017-05-15

    Hickory Springs Recalls Summit Seat Covers for Air Bag Deployment Risk

    Hickory Springs is recalling Summit-brand seat covers for RAM ProMaster, Ford Transit, and Mercedes Sprinter vehicles because the seam may prevent seat-mounted air bags from deploying.

    Product
    AIR BAGS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·050-2017·2017-05-13

    Green Chile Food Company Recalls Frozen Burritos Due to Listeria Risk

    Green Chile Food Company is recalling approximately 252,854 pounds of ready-to-eat frozen burrito products because they may be contaminated with Listeria monocytogenes.

    Product
    Green Chile Food Company Recalls Meat and Poultry Burrito Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    4 states
  • HighUSDA FSIS·049-2017·2017-05-12

    Valley Innovative Services Recalls Frozen Entrée Products Due to Listeria Risk

    Valley Innovative Services is recalling approximately 130,071 pounds of frozen entrée products containing waffles due to possible Listeria monocytogenes contamination.

    Product
    Valley Innovative Services Recalls Meat and Poultry Frozen EntrÇe Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·17151·2017-05-12

    Honeywell Recalls SWIFT Wireless Gateways for Fire Alarm Communication Failures

    Honeywell is recalling SWIFT wireless gateways sold with fire alarm systems because they may fail to communicate with detectors during a fire, leaving occupants unalerted.

    Product
    SWIFT wireless gateway sold with fire alarm systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17746·2017-05-12

    Little Passports Recalls Science Kits Due to Battery Burn Hazard

    Little Passports is recalling Science Expeditions Northern Lights kits because the included battery packs can overheat and cause burns. No injuries have been reported.

    Product
    Science Expeditions Northern Lights science kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V318000·2017-05-12

    Can-Am Recalls 2017 Spyder RT Motorcycles for Headlight Beam Issue

    Bombardier is recalling 2017 Can-Am Spyder RT motorcycles because a manufacturing error may cause headlights to shine too high, potentially blinding oncoming traffic.

    Product
    CAN-AM — CAN-AM SPYDER RT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V311000·2017-05-11

    Toyota Recalls Tundra and Sequoia for Cracking Lugnuts

    Toyota is recalling 2013-2017 Tundra and Sequoia vehicles with specific aftermarket wheels because lugnuts may crack and detach, increasing crash risk.

    Product
    TOYOTA — TOYOTA SEQUOIA, TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V312000·2017-05-11

    Thomas Built Buses Recalls Minotour School Buses for Seat Defect

    Daimler Trucks North America is recalling 2016-2018 Thomas Built Buses Minotour school buses because occupant seats may lack reinforcement brackets, increasing injury risk in crashes.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V313000·2017-05-11

    Thomas Built Buses Recalling School Buses for Seat Washer Defect

    Daimler Trucks is recalling 2014-2018 Thomas Built Buses Saf-T-Liner EFX and HDX school buses because occupant seats may lack under-rail washers, reducing anchorage strength.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V309000·2017-05-11

    Volkswagen Recalls 2012-2014 Passat Diesel Models for Fire Risk

    Volkswagen is recalling 2012-2014 Passat diesel vehicles because a short heat shield may allow grease to leak and contact hot exhaust parts, increasing fire risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V314000·2017-05-11

    Thomas Built Buses Recalls Saf-T-Liner HDX Models for Seat Belt Defect

    Daimler Trucks North America is recalling 2013-2018 Thomas Built Saf-T-Liner HDX buses because seat lap belts may be anchored to the seat rather than the bus structure, increasing injury risk in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V317000·2017-05-11

    Thomas Built Buses Recalls 2013-2018 Saf-T-Liner HDX School Buses

    Daimler Trucks North America is recalling 2013-2018 Thomas Built Saf-T-Liner HDX school buses because seat lap belts may be anchored to the seat rather than the bus structure.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17149·2017-05-11

    Nature's Truth Recalls Iron Supplements Due to Non-Child-Resistant Packaging

    Nature's Truth is recalling Slow Release Iron 45 mg supplements because the bottles do not meet child-resistant closure requirements. Consumers should keep the product away from children and return it for a refund or replacement.

    Product
    Nature's Truth Slow Release Iron Supplements
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17150·2017-05-11

    Carrier and Bryant Heat Pumps Recalled for Fire Hazard

    Carrier and Bryant are recalling about 23,300 heat pumps because capacitors can fail, causing the units to overheat and pose a fire hazard.

    Product
    Carrier Greenspeed™ and Bryant Evolution Extreme™ Heat Pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·048-2017·2017-05-11

    NY Livestock Market Recalls Poultry for Nitrofurazone Residue

    NY Livestock Market, Inc. is recalling approximately 1,495 pounds of whole young chickens due to possible nitrofurazone contamination.

    Product
    NY Livestock Market Inc. — NY Livestock Market, Inc. Recalls Poultry Products Due to Possible Residue Contamination
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0690-2017·2017-05-10

    EpiPen Auto-Injectors Recalled for Defective Delivery System

    Meridian Medical Technologies is recalling EpiPen auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.

    Product
    EPIPEN — EPIPEN (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2173-2017·2017-05-10

    Killer Brownie German Chocolate Brownies Recalled for Undeclared Peanuts

    Killer Brownie Distributing LLC is recalling German Chocolate Killer Brownies due to undeclared peanuts, a potential allergen hazard.

    Product
    GERMAN CHOCOLATE KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Nuts: Pecans, Soy, Wheat UPC 10858061005321. Item #483-2016
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2167-2017·2017-05-10

    FDA Recalls Life Rising SHT Chest Relief Due to Lead Contamination

    Ton Shen Health Inc is recalling Life Rising Formulas SHT Chest Relief capsules because the product is potentially contaminated with lead. The recall affects 37 bottles distributed in Illinois.

    Product
    Life Rising Formulas SHT Chest Relief, 54 Capsules; Manufactured for: Nature's Health (USA) Chicago, IL 60616
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2175-2017·2017-05-10

    Killer Brownie Recalls Brownies for Undeclared Peanuts

    Killer Brownie Distributing LLC is recalling Original KB Killer Brownies due to undeclared peanuts. The product was distributed to Minnesota, New York, Ohio, Pennsylvania, and Wisconsin.

    Product
    ORIGINAL KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Nuts: Pecans, Soy, Wheat UPC 10858061005031. Item #48-2016
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2180-2017·2017-05-10

    Aroma Imports Recalls Nabelsi Thyme Due to Elevated Lead Levels

    Aroma Imports Inc is recalling Nabelsi Thyme (Zatar) in 450g and 4.5kg packages due to elevated lead levels. The product was distributed in five states.

    Product
    Nabelsi Thyme (also known on invoices as Zatar) 450g retail (24 packages per wholesale case) 4.5kg retail (2 bags per wholesale case) Cardboard box wholesale case, retail packages flexible plastic
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2169-2017·2017-05-10

    Seafarers Recalls Fresh Jumbo Lump Crabmeat Due to Listeria Risk

    Seafarers Inc. is recalling approximately 9,961 lbs of Fresh Jumbo Lump Crabmeat from Venezuela due to potential Listeria monocytogenes contamination.

    Product
    Precooked, chilled, Fresh Jumbo Lump Crabmeat, 1 lb, packaged in plastic container with plastic lid. King Crab and Seafood De Venezuela, product of Venezuela.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Drugs)·D-0691-2017·2017-05-10

    EpiPen Jr. Auto-Injectors Recalled for Delivery System Defects

    Meridian Medical Technologies is recalling EpiPen Jr. auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.

    Product
    EPIPEN — EPIPEN (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2174-2017·2017-05-10

    Killer Brownie Distributing Recalls Brownies Due to Undeclared Peanuts

    Killer Brownie Distributing LLC is recalling Killer Brownie products due to undeclared peanuts. The mislabeled items were distributed to five states.

    Product
    NOT-A-NUTTER KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Soy, Wheat UPC 10858061005314. Item #482-2016
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-2166-2017·2017-05-10

    La Granja Mango Ice Cream Recalled for Possible Salmonella Contamination

    La Granja Inc is recalling 4,000 units of 4-ounce mango ice cream bars due to possible Salmonella Enteritidis contamination. The product was distributed in Alabama, Georgia, North Carolina, and South Carolina.

    Product
    Hand Crafted, LG Paleteria, La Granja, Mango Flavored Ice cream, Wt. 4 oz., in clear flexible plastic wrap.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-2168-2017·2017-05-10

    Clancy's Snack Combo Pack Recalled for Undeclared Milk Allergen

    Olde York Potato Chips is recalling Clancy's Snack Combo Packs sold at ALDI in eight states due to undeclared milk.

    Product
    Clancys Snack Combo Pack 20 x 1 oz; Each 20 oz selling unit contains 4 x 1 oz bags of Original Potato Chips, 4 x 1 oz bags of Sour Cream & Onion Potato Chips, 4 x 1 oz bags of Barbecue Potato Chips, 3 x 1 oz bags of Nacho Tortilla Chips, 3 x 1 oz bags of Ranch Tortilla Chips, a
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-2182-2017·2017-05-10

    Beyond Meat Recalls Feisty Crumbles for Undeclared Peanuts

    Beyond Meat is recalling specific lots of Beyond Beef Feisty Crumbles due to undeclared peanuts. The recall covers products distributed in California, Florida, Missouri, and Illinois.

    Product
    Beyond Beef Feisty Crumble Vegan Gluten-free Non-GMO Weight: 10 lbs. (2) 5 lb. bags UPC: 10852629004412 KEEP FROZEN 111 Main Street El Segundo, CA 90245 866-756-4112 [email protected] www.beyondmeat.com; Beyond Meat Beyond Beef Crumbles Feisty Net WT 11oz (312g) KEEP FROZEN
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-2170-2017·2017-05-10

    Seafarers Recalls Fresh Lump Crabmeat Due to Listeria Contamination Risk

    Seafarers Inc. is recalling pre-cooked, chilled Fresh Lump Crabmeat because it may be contaminated with Listeria monocytogenes. The product was distributed to nine states.

    Product
    Pre-cooked, chilled, Fresh Lump Crabmeat, 1 lb, packaged in plastic container with plastic lid. King Crab and Seafood De Venezuela, product of Venezuela.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1929-2017·2017-05-10

    Olympus Endoeye HD II Video Telescopes Recalled for Overheating Tip

    Olympus is recalling 863 Endoeye HD II video telescopes because a damaged temperature sensor can cause the tip to become abnormally hot.

    Product
    Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2171-2017·2017-05-10

    FDA Recalls Fresh Claw Crabmeat Due to Listeria Monocytogenes Contamination

    Seafarers Inc. is recalling pre-cooked, chilled Fresh Claw Crabmeat from Venezuela because it may be contaminated with Listeria monocytogenes.

    Product
    Pre-cooked, chilled, Fresh Claw Crabmeat, 1 lb, packaged in plastic container with plastic lid. King Crab and Seafood De Venezuela, product of Venezuela.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2034-2017·2017-05-10

    Sysmex XN Series Hematology Analyzers Recalled for Fire Risk

    Sysmex America Inc is recalling XN-10 and XN-11 hematology analyzers due to a risk of fire caused by misaligned internal protective sheets.

    Product
    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1899-2017·2017-05-10

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Error

    Roche Diabetes Care is recalling specific versions of the Accu-Chek Connect app because a bug in the Bolus Advisor feature may provide incorrect insulin dosing advice.

    Product
    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·047-2017·2017-05-10

    Kabob's Acquisition Recalls Monte Cristo Sandwiches Due to Listeria Risk

    Kabob's Acquisition is recalling approximately 5,946 pounds of Monte Cristo sandwiches because a French toast ingredient was recalled for possible Listeria contamination.

    Product
    Kabobs Aquisition, LLC — Kabob's Acquisition, Inc. Recalls Meat and Poultry Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2177-2017·2017-05-10

    Trail's End Chicago Sports Collection Snack Tins Recalled for Salmonella Risk

    Weaver Popcorn Co. is recalling Trail's End Chicago sports collection snack tins due to potential Salmonella contamination.

    Product
    Trail's End Chicago Cubs Sweet and Savory Collection Trail's End Chicago Cubs Chocolate Lover's Collection Trail's End Chicago Blackhawks Collection Tin Snack mixes containing: Chocolate Caramel Corn; Chocolate Pretzels; White Chocolate Pretzels; White Cheddar Popcorn; B
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2176-2017·2017-05-10

    Killer Brownie Peanut Butter Brownies Recalled for Undeclared Peanuts

    Killer Brownie Distributing LLC is recalling Peanut Butter KB Killer Brownies due to undeclared peanuts. The product was distributed to five states.

    Product
    PEANUT BUTTER KB KILLER BROWNIE¿ 3x35 CT NET WT 36 lbs (16.33 kg) CONTAINS: Milk, Nuts: Peanuts, Soy, Wheat UPC 10858061005048 . Item # 484-2016
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2165-2017·2017-05-10

    Goya Octopus in Vegetable Oil Recalled for Squid Mislabeling

    Tradewind Foods is recalling Goya Octopus in Vegetable Oil because the product contains squid instead of octopus, posing a risk to consumers with seafood allergies.

    Product
    Goya Octopus in Vegetable Oil, Pulpo en Aceite Vegetal, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secaucus N.J. 07096.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1897-2017·2017-05-10

    BD FlowSmart Set MiniMed Pro-set Recalled for Bent Catheters

    Becton Dickinson is recalling 57,750 units of BD FlowSmart Set MiniMed Pro-set in California due to reports of bent catheters causing high blood glucose.

    Product
    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1924-2017·2017-05-10

    Natus Medical Recalls neoBLUE 2 Phototherapy Lights for Intensity Defect

    Natus Medical is recalling neoBLUE 2 phototherapy lights sold from 2003 to 2008 to prevent the use of replacement boards that allow higher light intensity than originally cleared.

    Product
    Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2183-2017·2017-05-10

    Urban Remedy Recalls Mislabeled Cold Pressed Apple Juice

    Urban Remedy is voluntarily recalling 656 bottles of Whole Foods Market Cold Pressed Juice, Apple, because the product was mislabeled and contains undeclared tree nuts.

    Product
    Whole Foods Market Cold Pressed Juice, Apple; 16 FL. Oz. (1 pt) 473 mL. Keep refrigerated - Enjoy within 5 days of opening. UPC 8 13377 02154 3
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1921-2017·2017-05-10

    Roho Sensor Ready Cushions Recalled for Improper Setup Risk

    Roho Inc. is recalling 5,646 units of ROHO High and Mid Profile cushions because the Smart Check tool may cause improper inflation, increasing the risk of skin or soft tissue injury.

    Product
    ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2163-2017·2017-05-10

    Goya Octopus in Hot Sauce Recalled for Squid Mislabeling

    Tradewind Foods is recalling Goya Octopus in Hot Sauce because the product contains squid instead of octopus, posing a risk to consumers with octopus allergies.

    Product
    Goya Octopus in Hot Sauce, Pulpo en Salsa Picante, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secaucus N.J. 07096.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1890-2017·2017-05-10

    Medtronic Recalls MiniMed 620G and 640G Insulin Pumps Due to Software Anomaly

    Medtronic is recalling MiniMed 620G and 640G insulin pumps with software version 2.6 or below because a software anomaly can prevent the internal battery from charging, leading to pump shutdown.

    Product
    MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1901-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling sterile dressings (P/N 02328) because a small percentage may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17148·2017-05-10

    AM Conservation Group Recalls Luminescent Night Lights Due to Fire Hazard

    AM Conservation Group is recalling about 37,000 luminescent night lights because they can overheat and pose a fire hazard. Consumers should stop using the products and contact the firm for a free replacement.

    Product
    Luminescent night lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1903-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Dressing Rect L (P/N 02428) because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2161-2017·2017-05-10

    Goya Octopus in Garlic Sauce Recalled for Squid Mislabeling

    Tradewind Foods is recalling Goya Octopus in Garlic Sauce because the product contains squid instead of octopus. This mislabeling poses a risk to consumers with seafood allergies.

    Product
    Goya Octopus in Garlic Sauce, Pulpo al Ajillo, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secaucus N.J. 07096.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1900-2017·2017-05-10

    Bard MR GHIATAS Beaded Breast Localization Wire Recalled for Compatibility Risk

    Bard Peripheral Vascular Inc. is recalling 570 units of MR GHIATAS Beaded Breast Localization Wire because they may be non-MR compatible instead of MR compatible.

    Product
    MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2172-2017·2017-05-10

    Nassau Candy Recalls Pomegranate Cranberries for Undeclared Almonds

    Nassau Candy is recalling H.E. B. brand Pomegranate Infused Cranberries Covered in Dark Chocolate because the product may contain undeclared almonds.

    Product
    H.E. B. brand Pomegranate Infused Cranberries COVERED IN Dark Chocolate, NET WT. 8 OZ. (227g), UPC CODE 041220985883
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·17E025000·2017-05-10

    Sprague Heavy-Duty Bus Wiper Arms Recalled for Mounting Casting Cracks

    Sprague Devices is recalling Heavy-Duty Bus Pantograph Wiper Arms because the mounting casting may crack, causing the arms to bend or detach and reducing driver visibility.

    Product
    VISIBILITY:WINDSHIELD WIPER/WASHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2017·2017-05-10

    Merge Healthcare Recalls Schiller CO2 Sensors Due to Alarm Bias

    Merge Healthcare is recalling 23 Schiller CO2 sensors that may display false clogging alarms, potentially adding bias to CO2 measurements and affecting alarm notifications.

    Product
    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1928-2017·2017-05-10

    Dale Medical Stabilock Endotracheal Adhesive Base Recalled for Adhesive Failure

    Dale Medical Products is recalling Stabilock Endotracheal Adhesive Bases because the adhesive faceplate may lose its properties and fail to adhere to the patient's face.

    Product
    Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that atta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2017·2017-05-10

    Dale Medical Stabilock Endotracheal Tube Holder Recall for Adhesive Failure

    Dale Medical Products is recalling Stabilock Endotracheal Tube Holders because the adhesive faceplate may lose its properties and fail to adhere to the patient's face.

    Product
    Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attach
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2017·2017-05-10

    Medtronic Recalls Newport HT70 Ventilators Due to Spontaneous Shutdown Risk

    Medtronic is voluntarily recalling Newport HT70 and HT70 Plus ventilators because they may shut down spontaneously without an alarm during normal operation.

    Product
    Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation thr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2027-2017·2017-05-10

    Anspach Effort Recalls Jacobs Chuck Attachment Due to Missing Service Interval

    The Anspach Effort, Inc. is recalling 50 units of the SMALL ATTACHMENT, JACOBS CHUCK because the supplied directions for use did not contain a recommended service interval.

    Product
    SMALL ATTACHMENT, JACOBS CHUCK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1955-2017·2017-05-10

    Anspach Effort eMax2 Plus Console Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 439 eMax2 Plus consoles because the supplied directions for use did not contain a recommended service interval.

    Product
    Console, eMax2 Plus Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2017·2017-05-10

    Anspach Effort B-Sagittal Assembly Pneumatic System Recall

    The Anspach Effort, Inc. is recalling five B-Sagittal Assembly pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1922-2017·2017-05-10

    Boston Scientific Recalls Mislabeled JETSTREAM Atherectomy Catheters

    Boston Scientific is voluntarily removing three lots of JETSTREAM atherectomy catheters because some units were mislabeled with incorrect sizes.

    Product
    The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspi
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-1978-2017·2017-05-10

    Anspach Effort Recalls 26.65cm Attachment for Missing Service Interval

    The Anspach Effort, Inc. is recalling 16 units of the 26.65cm Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.

    Product
    26.65CM ATTACHMENT, BLACK MAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1953-2017·2017-05-10

    Anspach Effort SC2100 Foot Control Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 320 SC2100 Foot Controls because the supplied directions for use did not contain a recommended service interval.

    Product
    Foot Control, SC2100 Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2162-2017·2017-05-10

    Goya Octopus in Olive Oil Recalled for Squid Mislabeling

    Tradewind Foods is recalling Goya Octopus in Olive Oil because the product contains squid instead of octopus. This labeling error affects consumers in Puerto Rico and the Caribbean.

    Product
    Goya Octopus in Olive Oil, Pulpo en Aceite de Oliva, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secaucus N.J. 07096.
    Category
    Food
    Distribution
    2 states

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