The Recall Desk

Archive

May 2019 recalls

587 recalls were announced in May 2019.

What the numbers show

Critical
22
Severe
152
High
209
Moderate
184
Low
20

Of the 587 recalls this month scored against our rubric, 4% are Critical, 26% are Severe.

501–587 of 587

  • SevereUSDA FSIS·049-2019·2019-05-04

    Conagra Recalls P.F. Chang's Chicken Entrees for Undeclared Milk Allergen

    Conagra Brands is recalling P.F. Chang's Home Menu Chicken Pad Thai and Chicken Fried Rice products because they contain undeclared milk, a known allergen.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — Conagra Brands, Inc. Recalls Chicken Pad Thai and Chicken Fried Rice Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·19V342000·2019-05-03

    Taylor Made Recalls 2017-2018 Ambulances with Whelen Brake Light Defect

    Taylor Made Ambulances is recalling 2017-2018 Ford and GMC-based ambulances because Whelen brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    FORD — FORD, GMC E-350, F-550, G3500, E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V344000·2019-05-03

    MCI Buses Recalled for Risk of Shattering Glass Roof Hatches

    Motor Coach Industries is recalling specific 2018-2019 MCI buses because temperature and vibration stresses may cause the tempered glass roof hatch to shatter, potentially injuring passengers.

    Product
    MCI — MCI J3500, J4500, D4505
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19115·2019-05-02

    Excalibur EZ DRY Food Dehydrators Recalled Due to Fire Hazard

    Greenfield World Trade is recalling Excalibur EZ DRY food dehydrators because they can overheat, posing a fire hazard and causing minor burn injuries.

    Product
    Excalibur EZ DRY food dehydrators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·19745·2019-05-02

    BRP Recalls 2017 Ski-Doo Snowmobiles Due to Fuel Leak and Fire Hazard

    BRP is recalling approximately 10,000 2017 Ski-Doo MXZ, Summit, and Renegade snowmobiles because a fuel leak can cause a fire. No injuries have been reported.

    Product
    2017 Ski Doo MXZ, Summit and Renegade snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19744·2019-05-02

    FIRMAN Recalls Portable Generators Due to Fire Hazard

    FIRMAN Power Equipment is recalling P03615 portable generators sold at Costco because the carbon canister can leak gas, posing a fire hazard.

    Product
    FIRMAN P03615 generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1325-2019·2019-05-01

    Winter Gardens Chips & Chocolate Dessert Recalled for Salmonella Risk

    Winter Gardens Quality Foods is recalling Chips & Chocolate dessert trays due to potential Salmonella contamination. The product was distributed in Maryland, Pennsylvania, and Delaware.

    Product
    Chips & Chocolate, A layered dessert with chocolate mousse layer on the bottom, with a white whipped topping layer on top topped with chocolate chips, 5 lb. tray, UPC Code 010742015408
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-1116-2019·2019-05-01

    Edwards Lifesciences Recalls Fogarty Dilation Atrioseptostomy Catheters

    Edwards Lifesciences is recalling Fogarty Dilation Atrioseptostomy Catheters due to reports of balloon fragmentation or detachment and difficulty deflating the balloon after deployment.

    Product
    Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1406-2019·2019-05-01

    French cheese recalled due to potential Listeria monocytogenes contamination

    Societe Fromagere de la Brie is recalling French cheese products due to potential Listeria monocytogenes contamination. Consumers should not consume the affected items.

    Product
    Formagere de la Brie FORMAGE FRANCAIS l'Explorateur, packaged in a plastic container, in 100g, 250g - UPC: 3 390010004080, and 1kg packages.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1214-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 6,746 bags of Magnesium Sulfate 2 GM in NS 50 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1232-2019·2019-05-01

    Phenylephrine IV Bags Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 215 bags of Phenylephrine 40 mg in 0.9% Sodium Chloride due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1209-2019·2019-05-01

    Dexmedetomidine Bags Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 5,678 bags of Dexmedetomidine 400 mcg in NS 100 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1224-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls CeFAZolin Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling CeFAZolin 1 GM products in North Carolina due to a lack of sterility assurance.

    Product
    CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1219-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Oxytocin Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 3,690 bags of Oxytocin 30 units in NS 500 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1235-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 1000 mg in NS 250 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1211-2019·2019-05-01

    Diltiazem 250 mg IV Bags Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 1,475 bags of Diltiazem 250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1213-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 2,162 bags of Magnesium Sulfate 1 GM in NS 50 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1227-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls CefTRIAXone Syringes Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 15 syringes of CefTRIAXone 1 GM due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1218-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Norepinephrine Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 2,567 bags of Norepinephrine 16 mg in NS 250 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1217-2019·2019-05-01

    Enterprise Pharmacy Recalls Nifedipine Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 1,783 bags of Nifedipine 25 mg in NS 250 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1240-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls DelNido Cardioplegia Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 110 bags of DelNido Cardioplegia in North Carolina due to a lack of sterility assurance.

    Product
    DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by: Enter
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1229-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Heparin Pork Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 87 bags of Heparin Pork 30,000 Units in NS 1000 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1210-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Clindamycin Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 1,233 bags of Clindamycin 900 mg in NS 50 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1239-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 2000 mg in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1237-2019·2019-05-01

    Vancomycin 1500 mg Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 715 bags of Vancomycin 1500 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1215-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 3,007 bags of Magnesium Sulfate 4 GM in NS 50 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1117-2019·2019-05-01

    Edwards Miller Balloon Atrioseptostomy Catheter Recalled for Deflation Issues

    Edwards Lifesciences is recalling Miller Balloon Atrioseptostomy Catheters due to difficulty deflating the balloon and reports of fragmentation or detachment.

    Product
    Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1228-2019·2019-05-01

    Chlorothiazide Syringes Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 60 syringes of Chlorothiazide 100 mg due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1222-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 40 syringes of Lidocaine 1% - Sodium Bicarb 8.4% 10:1 for intradermal use due to a lack of sterility assurance.

    Product
    Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1216-2019·2019-05-01

    Magnesium Sulfate IV Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 196 bags of Magnesium Sulfate 6 GM in NS 50 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1225-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls CeFAZolin Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling specific lots of CeFAZolin 2 GM in bags and syringes due to a lack of sterility assurance. The products were distributed in North Carolina.

    Product
    CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1231-2019·2019-05-01

    Phenylephrine IV Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 390 bags of Phenylephrine 20 mg NS 250 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1238-2019·2019-05-01

    Vancomycin Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 118 bags of Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL due to lack of sterility assurance.

    Product
    Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1234-2019·2019-05-01

    Sodium Citrate Syringes Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 40 syringes of Sodium Citrate 4% due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1236-2019·2019-05-01

    Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 737 bags of Vancomycin 1250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1230-2019·2019-05-01

    Phenylephrine Syringes Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 1,310 syringes of Phenylephrine 0.8 mg/10 mL NS due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1223-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling Lidocaine 1% - Sodium Bicarbonate 8.4% syringes due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1212-2019·2019-05-01

    Labetalol Syringes Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 6,667 Labetalol syringes due to a lack of sterility assurance. The affected products were distributed in North Carolina.

    Product
    Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1233-2019·2019-05-01

    Sodium Bicarbonate IV Bags Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 100 bags of Sodium Bicarbonate 150 mEq in D5W 1000 mL due to lack of sterility assurance.

    Product
    Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1220-2019·2019-05-01

    Alteplase Syringes Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 97 syringes of Alteplase 1 mg/mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1221-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 705 syringes of Lidocaine Buffered with J-Tip due to a lack of sterility assurance. The products were distributed in North Carolina.

    Product
    Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1299-2019·2019-05-01

    Patagonia Provisions Savory Seeds Recalled for Gluten Contamination

    Patagonia Provisions is recalling Savory Seeds Variety Packs labeled gluten-free because they contain gluten in excess of 20 ppm.

    Product
    Patagonia Provisions Savory Seeds Variety Pack; Classic Barbecue, Chipolte Lime, Mellow Curry 1 oz. poly-film pouches, 12 packages per case Vegan, Gluten Free Distributed by Patagonia Provisions, Inc. Sausalito, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2019·2019-05-01

    Siemens Digital Linear Accelerators Recalled for Motion Protection Safety Advisory

    Siemens Medical Solutions USA is recalling 120 digital linear accelerators nationwide to prevent patient or user injury from disabling the Automatic Motion Protection function.

    Product
    Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software versio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1226-2019·2019-05-01

    Cefazolin Syringes Recalled Due to Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 475 cefazolin syringes distributed in North Carolina because they lack sterility assurance.

    Product
    CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·19V339000·2019-05-01

    Indian Recalls 2014 Chief and Chieftain Motorcycles for Lighting Defect

    Indian Motorcycle is recalling 2014 Chief and Chieftain models because a Vehicle Control Module issue may cause all front lights to go out, increasing crash risk.

    Product
    INDIAN — INDIAN CHIEF CLASSIC, CHIEFTAIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2019·2019-05-01

    TriMed Hex Cortical Screw Recalled for Shorter Than Specified Length

    TriMed Inc. is recalling 13 Hex Cortical Screws from the Ankle Fixation System because they are shorter than the intended design specification.

    Product
    TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-4
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1222-2019·2019-05-01

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling 80 VITROS XT 7600 Integrated Systems because a software error may cause incorrect test results without alerting the user.

    Product
    VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2019·2019-05-01

    Covidien Endo Clinch II Auto Suture Grasper Recalled for Sterilization Issues

    COVIDIEN LLC is recalling 7,248 units of the Endo Clinch II Auto Suture Grasper because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2019·2019-05-01

    Thoratec HeartMate 3 Coring Tool Recalled for Foreign Particle Contamination

    Thoratec Corp. is recalling HeartMate 3 Coring Tools because a small black plastic particle was observed in a patient's left ventricle during an implant procedure.

    Product
    Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Cori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1304-2019·2019-05-01

    Denali Banana Puddin Base Recalled for Undeclared Egg Ingredient

    Denali Ingredients LLC is recalling 6,096 lbs of Banana Puddin Base due to undeclared egg. The product was distributed in Ohio and Pennsylvania.

    Product
    Banana Puddin Base, item # 70 0559-1034, in 5 gallon plastic pail. Net Wt: 48 LBS. Ice Cream Flavoring. Store Refrigerated (35-45F) at all times. Denali Ingredients LLC, 2400 S. Calhoun Rd, New Berlin, WI 53151
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1305-2019·2019-05-01

    Mineralife Trace Minerals Dietary Supplement Recalled for Pseudomonas Contamination

    Mineralife LLC is recalling Trace Minerals Dietary Supplement bottles due to potential contamination with Pseudomonas aeruginosa.

    Product
    Trace Minerals Dietary Supplement , 16.2 fl oz (480 mL) bottles, Packaged in dark blue plastic bottles, For freshness, keep refrigerated after opening
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1303-2019·2019-05-01

    Monarch Southern Barbecue Sauce Recalled for Missing Allergen Information

    The CF Sauer Company is recalling Monarch Southern Barbecue Sauce because the labels failed to declare soy and wheat allergens.

    Product
    MONARCH SOUTHERN BARBECUE SAUCE MADE WITH MUSTARD NET 128 FL OZ(1 GAL) 3.78L INGREDIENTS: WATER, HIGH FRUTOSE CORN SRYUP, SUGAR, TOMATO PASTE, DISTILLED AND CIDER VINEGAR, SALT ***DISTRIBUTED BY/DISTRIBUIDO POR US FOODS, INC., ROSEMOUNT, IL 60015 UPC 7 58108 60016 4
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1307-2019·2019-05-01

    Gianni's Fine Food Recalls Blue Cheese Vinaigrette for Undeclared Milk

    Gianni's Fine Food is recalling 17 bottles of blue cheese vinaigrette because the label failed to declare milk, a major allergen.

    Product
    Blue cheese & toasted walnut garlic balsamic vinaigrette, packaged in 6.3-fl. oz. glass bottle. The label is read in parts: "***Ingredients: balsamic vinegar, extra virgin olive oil, roasted walnuts, blue cheese crumbles, salt, pepper***giannisfinefoods.com***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1209-2019·2019-05-01

    Fresenius Kabi CATSmart Autotransfusion Device Recalled for Tubing Wear Risk

    Fresenius Kabi is recalling 342 CATSmart autotransfusion devices because tubing may contact the washing chamber, causing wear or puncture.

    Product
    Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Par
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V340000·2019-05-01

    PACCAR Recalls 2020 Peterbilt and Kenworth Trucks for Mirror Defect

    PACCAR is recalling 2020 Peterbilt and Kenworth trucks because mirror glass may detach, creating a road hazard and reducing driver visibility.

    Product
    PETERBILT — PETERBILT, KENWORTH 567, 579, T680, T800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2019·2019-05-01

    Stryker Performance Series Sagittal Blade Recall for Sterility Breach

    Stryker is recalling 355 Performance Series Sagittal Blades due to a potential breach in sterility caused by improper packaging positioning during manufacture.

    Product
    Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compart
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2019·2019-05-01

    Arthrex Burr Recalled for Excessive Heat Generation During Use

    Arthrex, Inc. is recalling specific lots of Arthrex Oval Burr devices because they may generate excessive heat during use, posing a risk of injury to patients.

    Product
    Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2019·2019-05-01

    FDA Recalls Safety Winged Blood Collection Sets Due to Needle Detachment

    Guangzhou Improve Medical Instruments is recalling 550,000 Prevent G Safety Winged Blood Collection Sets because the hub needle detached during use.

    Product
    Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1218-2019·2019-05-01

    Jelco ViaValve Safety Intravenous Catheters Recalled for Manufacturing Defect

    Smiths Medical ASD Inc. is recalling specific lots of Jelco ViaValve safety intravenous catheters due to a V-shaped puncture at the base of the catheter.

    Product
    Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19113·2019-05-01

    DAVIDsTEA Recalls Valentine's Day Stackable Mugs Due to Fire Hazard

    DAVIDsTEA is recalling about 700 Valentine's Day stackable mugs because they were mislabeled as microwave safe, posing a fire hazard if used in a microwave.

    Product
    Valentine's Day stackable mugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2019·2019-05-01

    Brainlab RT Elements Software Recalled for Incorrect Dose Calculation

    Brainlab AG is recalling specific versions of RT Elements software due to a potential for incorrect dose distribution calculations when using the Pencil Beam algorithm on the GPU.

    Product
    RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 -
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1298-2019·2019-05-01

    Patagonia Provisions Chipotle Lime Savory Seeds Recalled for Gluten Contamination

    Patagonia Provisions is recalling Chipotle Lime Savory Seeds labeled as gluten-free because they contain gluten in excess of 20 ppm.

    Product
    Patagonia Provisions Chipotle Lime Savory Seeds; 1 oz. poly-film pouches. 12 pouches per case Vegan, Gluten Free Distributed by Patagonia Provisions, Inc. Sausalito, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1247-2019·2019-05-01

    Lupin Recalls Morphine Sulfate Tablets for Impurity Specification Failures

    Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because they failed impurity and degradation specifications.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1220-2019·2019-05-01

    Abbott Recalls 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors

    Abbott is recalling 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors because the devices incorrectly determine that their security certificates have expired, preventing them from pairing with the mobile app.

    Product
    St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1101-2019·2019-05-01

    KaVo Orthopantomograph OP 3D Cone-Beam CT System Firmware Recall

    KaVo Dental Technologies is recalling 230 Orthopantomograph OP 3D cone-beam CT systems due to a defect in firmware versions 2.1.0 and 2.1.1.

    Product
    cone-beam CT system
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1212-2019·2019-05-01

    Covidien Endo Grasp Auto Suture Grasper Recalled for Sterilization Labeling Error

    COVIDIEN LLC is recalling 240 units of the Endo Grasp Auto Suture Grasper 5mm because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1296-2019·2019-05-01

    Patagonia Provisions Classic Barbecue Savory Seeds Recalled for Gluten Contamination

    Patagonia Provisions is recalling Classic Barbecue Savory Seeds labeled gluten-free because they contain gluten in excess of 20 ppm.

    Product
    Patagonia Provisions Classic Barbecue Savory Seeds; 1 oz. poly-film pouches. 12 units per case Vegan, Gluten Free Distributed by Patagonia Provisions, Inc. Sausalito, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1208-2019·2019-05-01

    Exactech Recalls Mismarked Truliant Tibial Fit Trays for Knee Replacement

    Exactech is recalling 18 Truliant Tibial Fit Trays because they were mismarked as size 3. The devices were distributed to facilities in 10 US states.

    Product
    Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1207-2019·2019-05-01

    Carestream OnSight 3D Extremity System Recalled for Software Data Error

    Carestream Health is recalling 37 OnSight 3D Extremity Systems because a software error may leave companion imaging volumes in the original patient's exam during re-assignment.

    Product
    OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1213-2019·2019-05-01

    Covidien Procedure Kits Recalled for Sterilization Labeling Inconsistency

    Covidien LLC is recalling 148 procedure kits because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII (6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1306-2019·2019-05-01

    Samira Food Products Soy Chunk Recalled for Undeclared Sulfites

    Traders West Inc is recalling Samira Food Products Vegeterian 100% Soy Chunk due to failure to declare sulfites.

    Product
    Samira Food Products Vegeterian 100% Soy Chunk, Net Wt. 8oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1302-2019·2019-05-01

    Mediterranean Brands Callaloo Greens Recalled for Potential Plastic Contamination

    American Pasteurization Company is recalling Mediterranean Brands Callaloo Greens due to potential contamination with plastic foreign material.

    Product
    Mediterranean Brands Callaloo Greens, Product 6017. Net Weight 15.0 lbs (6.90 Kgs). Keep Frozen. Manufactured for: MBI, Glenview, IL 60025
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1297-2019·2019-05-01

    Patagonia Provisions Mellow Curry Savory Seeds Recalled for Gluten

    Patagonia Provisions is recalling Mellow Curry Savory Seeds labeled gluten-free because they contain gluten in excess of 20 ppm.

    Product
    Patagonia Provisions Mellow Curry Savory Seeds; 1 oz. poly-film pouches. 12 pouches per case Vegan, Gluten Free Distributed by Patagonia Provisions, Inc. Sausalito, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1242-2019·2019-05-01

    Zydus Recalls Carvedilol Tablets Due to Foreign Tablet Fragments

    Zydus Pharmaceuticals is recalling Carvedilol tablets 3.125 mg because a customer complaint identified a fragmented tablet of another drug product mixed in the bottle.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1241-2019·2019-05-01

    Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure

    Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because it failed impurity specifications during stability testing.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1202-2019·2019-05-01

    Cytocell Recalls Aquarius CSF1R/RPS14 Probe Due to Labeling Error

    Cytocell Ltd. is recalling 19 units of the Aquarius CSF1R/RPS14 Probe Red due to an error in the chromomap labeling.

    Product
    Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1221-2019·2019-05-01

    Maquet Edi Catheter Recalled for Incorrect Expiry Date Labeling

    Getinge is recalling Maquet Edi Catheters because the single-pack boxes are labeled with the wrong expiry date. The recall covers 17 boxes distributed in the US and several countries.

    Product
    Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragm
    Category
    Medical Device
    Distribution
    Distributed nationwide

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