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.

201–300 of 587

  • SevereFDA (Food)·F-1386-2019·2019-05-22

    AmeriHerb Mullein Leaf Recalled for Potential E. coli Contamination

    AmeriHerb International Inc is recalling 144 lbs of Mullein leaf due to potential E. coli contamination. The product was distributed nationwide and to Canada.

    Product
    Mullein leaf c/s, Verbascum Thapsus, 1# Net, AmeriHerb LLC, Ames, IA packaged in 1 lb plastic bags
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1388-2019·2019-05-22

    AmeriHerb Goldenseal Herb Recalled for Potential E. coli Contamination

    AmeriHerb International Inc is recalling 36 lbs of Goldenseal herb due to potential contamination with generic E. coli. The product was distributed nationwide and to Canada.

    Product
    Goldenseal herb c/s, Hydrastis Canadensis, Not for use during pregnancy, 1# Net, AmeriHerb LLC, Ames, IA packaged in 1 lb plastic bags
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·057-2019·2019-05-22

    Aurora Packing Recalls Raw Beef Products Due to E. coli O157:H7 Risk

    Aurora Packing Company is recalling approximately 62,112 pounds of raw beef products that may be contaminated with E. coli O157:H7. The products were shipped nationwide for further distribution and processing.

    Product
    Aurora Packing Company, Inc. — Aurora Packing Company, Inc. Recalls Beef Products Due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1270-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery is recalling 434,614 Curved Intraluminal Staplers (Model CDH33A) because they may have an insufficient firing stroke to break the washer and form staples.

    Product
    Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1276-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect

    Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH25A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V384000·2019-05-22

    Newmar Recalls 2019 Motorhomes Due to Loose Brake Caliper Bolts

    Newmar is recalling 2019 Mountain Aire and Essex motorhomes because loose brake caliper mounting bolts may reduce brake effectiveness and increase crash risk.

    Product
    NEWMAR — NEWMAR ESSEX, MOUNTAIN AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1278-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect

    Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH33A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1351-2019·2019-05-22

    Molift 2-Point Sling Bar Recalled Due to Hook Breakage Risk

    Moller Vital is recalling 427 Molift 2-Point sling bars because broken hooks may cause the sling to slip, potentially leading to patient falls.

    Product
    Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1277-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect

    Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH29A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1352-2019·2019-05-22

    Molift 2-Point Sling Bar Recalled Due to Hook Breakage Risk

    Moller Vital is recalling Molift 2-Point sling bars because broken hooks may cause the sling to slip and patients to fall.

    Product
    Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1267-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery Inc is recalling Curved Intraluminal Staplers, Model CDH21A, because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1268-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery is recalling Curved Intraluminal Staplers, Model CDH25A, because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1342-2019·2019-05-22

    FDA Orders Recall of Juices International 12-Ounce Glass Bottled Juices

    Juices International is recalling 12-ounce glass bottled juices in the New York area due to a violation of a Consent Decree of Injunction.

    Product
    All Juice Drinks and Beverages in 12 ounce glass bottles including but not limited to Agony, Double Trouble, Front End Lifter, Irish (sea) Moss, Cashew Punch, Carrot Juice, Sorrel, Carrots & Beet, Carrot & Ginger, Ginger Beer, Pineapple Twist. Keep Refrigerated
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1271-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery is recalling 434,614 Endoscopic Curved Intraluminal Staplers because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1385-2019·2019-05-22

    AmeriHerb Recalls Dried Dill Weed Potentially Contaminated with E. coli

    AmeriHerb International Inc is recalling 1 lb bags of dried dill weed potentially contaminated with E. coli. The product was distributed nationwide and to Canada.

    Product
    Dill weed c/s, Anethum graveolens, 1# Net, AmeriHerb LLC, Ames, IA packaged in 1 lb plastic bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1387-2019·2019-05-22

    AmeriHerb Lemon Balm Leaf Recalled for Potential E. coli Contamination

    AmeriHerb International Inc is recalling 103 lbs of Lemon Balm Leaf due to potential E. coli contamination. The product was distributed nationwide and to Canada.

    Product
    Lemon balm leaf c/s, Melissa officinalis, 1# Net, AmeriHerb LLC, Ames, IA packaged in 1 lb plastic bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1321-2019·2019-05-22

    Philips SureSigns VS3 Monitor Recall Due to Software Defect

    Philips is recalling SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2019·2019-05-22

    Philips SureSigns VS3 Monitor Recall for High Pulse Rate Measurement Failure

    Philips is recalling SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2019·2019-05-22

    Terumo Electronic Patient Gas System Recalled for Inaccurate Gas Flow Rate

    Terumo is recalling 1,258 Electronic Patient Gas Systems because a flowmeter defect may cause inaccurate gas flow rate output.

    Product
    Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2019·2019-05-22

    Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Errors

    Pentax of America Inc is recalling 68 C2 CryoBalloon Pear Focal Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.

    Product
    Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplast
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1353-2019·2019-05-22

    Abbott ARCHITECT Estradiol Reagent Kit Recall for Mifepristone Interference

    Abbott is recalling ARCHITECT Estradiol Reagent Kits because patient results may be falsely elevated for individuals currently or recently treated with Mifepristone.

    Product
    Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2019·2019-05-22

    BD Veritor System Reader Recalled for Potential False Test Results

    Becton Dickinson is recalling 124 BD Veritor System Readers due to background calibration issues that may cause false positive or negative test results.

    Product
    BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans FILTRON 2000 Medical Devices

    Shippert Medical Technologies is voluntarily recalling 6,553 units of Tissu-Trans FILTRON 2000 sterile, disposable, one-patient use devices due to a Class II classification.

    Product
    Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1313-2019·2019-05-22

    BD Veritor Plus Analyzer Recalled for Potential Test Result Errors

    Becton Dickinson & Co. is recalling 32 BD Veritor Plus Analyzers because background calibration issues may cause false positive or negative test results.

    Product
    BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans Syringe Fill 360 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans Syringe Fill 360 devices because the sterile pouch integrity cannot be assured without visual examination.

    Product
    Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2019·2019-05-22

    Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Error

    PENTAX of America Inc is recalling 4 C2 CryoBalloon Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.

    Product
    Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1335-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans MEGA 1500 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 sterile pouches because a cut or hole may compromise sterility.

    Product
    Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2019·2019-05-22

    Philips SureSigns VS3 Monitor Software Defect Recall

    Philips is recalling SureSigns VS3 patient monitors because a software defect prevents the device from measuring or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery Inc is recalling 434,614 Curved Intraluminal Staplers (Model CDH29A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2019·2019-05-22

    Ethicon Endo-Surgery Recalls 33 mm Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery Inc is recalling 434,614 Model ECS33A staplers worldwide because they may have an insufficient firing stroke to break the washer and form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V389000·2019-05-22

    Volkswagen Recalls Passat and Atlas Vehicles for Headlight Adjustment Defect

    Volkswagen is recalling 2012-2020 Passat and 2018-2019 Atlas vehicles because a missing blocking cap allows headlight aim to be adjusted out of specification, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1384-2019·2019-05-22

    AmeriHerb Blessed Thistle Herb Recalled for Potential E. coli Contamination

    AmeriHerb International Inc is recalling 108 lbs of Blessed Thistle herb due to potential contamination with generic E. coli. The product was distributed nationwide and to Canada.

    Product
    Blessed thistle herb c/s, Centaurea benedicus, Not for use during pregnancy, 1# Net, AmeriHerb LLC, Ames, IA packaged in 1 lb plastic bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1347-2019·2019-05-22

    Graze Dark Chocolate Cherry Tart Recalled for Undeclared Almonds

    Nature Delivered Inc. is recalling Graze Dark Chocolate Cherry Tarts because the product contains almonds that are not declared on the label.

    Product
    Graze, Dark Chocolate Cherry Tart net weight / number of units per package: 1.6oz (44g), 1 unit per package, package type: plastic container (PET/PE) in a cardboard sleeve, units per case: 6 x units per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1446-2019·2019-05-22

    Twin City Foods Recalls Frozen Green Peas and Diced Carrots

    Twin City Foods Inc. is recalling Signature Kitchens Green Peas & Diced Carrots due to potential Listeria monocytogenes contamination.

    Product
    Signature Kitchens Green Peas & Diced Carrots; Net Wt 16 oz (1 lb) 453 g; UPC 2113009154; frozen
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1389-2019·2019-05-22

    Ukrop's Baked Potatoes with Cheddar Cheese and Bacon Recalled for Mislabeling

    Ukrop's Homestyle Foods is recalling Baked Potatoes with Cheddar Cheese and Bacon mislabeled as Herb Roasted Potatoes due to undeclared allergens.

    Product
    Product labeled "Herb Roasted Potatoes", packed in 16oz plastic tray with clear plastic shrink-wrapping. Product is visible through clear plastic wrap. Product inside is Baked Potatoes with Cheddar Cheese and Bacon.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1383-2019·2019-05-22

    AmeriHerb Parsley Flakes Recalled for Potential E. coli Contamination

    AmeriHerb International Inc is recalling 256 lbs of parsley flakes potentially contaminated with E. coli. The product was distributed nationwide and to Canada.

    Product
    Parsley flakes, Petroselinum sativum, 1# Net, AmeriHerb LLC, Ames, IA packaged in 1 lb plastic bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1341-2019·2019-05-22

    Union Fish Company Recalls Vega White Headless Shrimp Due to Salmonella

    Union Fish Company is recalling Vega White Headless Shrimp after FDA import samples tested positive for Salmonella poly D. The product was distributed in California and Hawaii.

    Product
    Vega White Headless Shrimp, 21/15 and 26/30 count size. Frozen block in plastic bag, 6 x 4 lbs. per master carton. Product of the Philippines Processed and Packed by HJR International Corp.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1348-2019·2019-05-22

    Dangonds Arepas de Queso Recalled for Undeclared Milk Allergen

    Dangonds Foods LLC is recalling Dangonds Arepas de Queso because the label fails to list milk as an ingredient. The issue was identified during a Florida Department of Agriculture inspection.

    Product
    Dangonds Arepas de Queso, Net Weight 1,400g
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1272-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery is recalling 434,614 Endoscopic Curved Intraluminal Staplers (Model ECS25A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans FILTRON 1000 Medical Devices

    Shippert Medical Technologies is voluntarily recalling 6,553 units of Tissu-Trans FILTRON 1000 sterile, disposable, one-patient use devices due to a Class II safety concern.

    Product
    Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans FILTRON 250 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans FILTRON 250 sterile filters because the pouch integrity cannot be assured without visual examination.

    Product
    Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1323-2019·2019-05-22

    Philips SureSigns VS4 Monitor Software Defect Recall

    Philips is recalling SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2019·2019-05-22

    Philips SureSigns VS3 Monitor Software Defect Recalled

    Philips is recalling 518 SureSigns VS3 monitors because a software defect prevents the device from measuring or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2019·2019-05-22

    Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Errors

    Pentax of America Inc is recalling 157 C2 CryoBalloon Standard Focal Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.

    Product
    Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysp
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1340-2019·2019-05-22

    Siemens Artis Zeego Angiography Systems Recalled for Tabletop Movement Blockage

    Siemens is recalling 459 Artis Zeego angiography systems because the floating tabletop movement may be blocked after a collision sensor activates.

    Product
    Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures tha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2019·2019-05-22

    Stryker Power-LOAD Cot Fastening System Recalled for Broken Floor Plates

    Stryker is recalling 3,285 Power-LOAD Cot Fastening Systems because the floor plates holding ambulance cot anchors may be broken.

    Product
    Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2019·2019-05-22

    R82 Wombat Living Activity Chair Recalled for Plastic Joint Breakage

    R82 A/S is recalling 68 Wombat Living activity chairs (wheelchairs) in North Carolina due to reports of the plastic joint connecting the back to the seat breaking.

    Product
    Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1342-2019·2019-05-22

    Siemens Artis Q Angiography Systems Recalled for Tabletop Movement Blockage

    Siemens is recalling 459 Artis Q angiography systems because the floating tabletop may become blocked after a collision sensor activates.

    Product
    Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans FILTRON 100 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans FILTRON 100 sterile pouches because a cut or hole may compromise the product's sterility.

    Product
    Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans FILTRON 500 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans FILTRON 500 sterile pouches because a cut or hole in the packaging may compromise the product's sterility.

    Product
    Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2019·2019-05-22

    Philips SureSigns VS4 Monitor Software Defect Recall

    Philips is recalling 366 SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2019·2019-05-22

    Philips SureSigns VS3 NBP Recall for Pulse Rate Measurement Limitation

    Philips is recalling SureSigns VS3 NBP monitors because software prevents the display and alarm for pulse rates above 240 beats per minute.

    Product
    SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1354-2019·2019-05-22

    Abbott Alinity i Estradiol Reagent Kit Recalled for False Results

    Abbott Ireland Diagnostics Division is recalling Alinity i Estradiol Reagent Kits because patient results may be falsely elevated for individuals treated with Mifepristone.

    Product
    Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2019·2019-05-22

    Siemens Artis Zee Angiography Systems Recalled for Tabletop Movement Blockage

    Siemens is recalling 459 Artis Zee angiography systems because the floating tabletop movement may be blocked after a collision sensor is activated.

    Product
    Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese pati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1320-2019·2019-05-22

    Philips SureSigns VS3 Monitor Software Defect Recall

    Philips is recalling 3,177 SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.

    Product
    SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1328-2019·2019-05-22

    Opgen Recalls GNR PNA FISH Control Slides Due to Performance Issues

    Opgen Inc is recalling 80 GNR PNA FISH Control Slides because they may show diminished performance before expiration, potentially causing invalid test results.

    Product
    CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Lig
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1300-2019·2019-05-22

    CVS Children's Allergy Liquid Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor 20 Single-Use 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1298-2019·2019-05-22

    DrKids Children's Allergy Relief Diphenhydramine Recalled for B. cepacia Contamination Risk

    Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine HCl due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1357-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling Maple Spice Granola because the product may contain pieces of aluminum.

    Product
    Back Roads Granola: Maple Spice Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1306-2019·2019-05-22

    CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1278-2019·2019-05-22

    Pfizer Recalls Relpax Tablets Due to Incorrect Strength Labeling

    Pfizer is recalling Relpax 40 mg tablets because secondary packaging incorrectly lists the strength as 20 mg. The error is on one side of the carton.

    Product
    Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1303-2019·2019-05-22

    DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Children's Natural Cough Syrup due to potential contamination with B. cepacia bacteria. This is a precautionary measure.

    Product
    DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1343-2019·2019-05-22

    MediPress Pneumatic Compression System Recalled for Missing Premarket Clearance

    Compass Health Brands is recalling the MediPress pneumatic compression system because a design change lacked proper FDA premarket clearance.

    Product
    MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1347-2019·2019-05-22

    MediPress Pneumatic Compression System Recalled for Lack of Clearance

    Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.

    Product
    MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Food)·F-1360-2019·2019-05-22

    Barlean's Ultra DHA Fish Oil Recalled for Undeclared Sulfites

    Barlean's is recalling Ultra DHA Fish Oil Omega-3 softgels due to undeclared sulfites. The product is distributed nationwide.

    Product
    Item FG 10083, Barlean's, Ultra DHA Fish Oil Omega-3, Lemonade Flavor, 90 softgels per bottle, UPC 7 05875 61004 9.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1355-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Coconut Ginger Granola because the product may contain pieces of aluminum.

    Product
    Back Roads Granola: Coconut Ginger Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1359-2019·2019-05-22

    Barlean's Cod Liver Oil Recalled for Undeclared Sulfites

    Barlean's is recalling Cod Liver Oil softgels due to undeclared sulfites. Sulfite levels do not exceed 10 ppm.

    Product
    Item FG 10037, Barlean s Cod Liver Oil Omega 3 EPA/DHA with Added Vitamin D, 100 softgel per bottle. UPC 7 05875 61010 0
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1364-2019·2019-05-22

    Barlean's Olive Leaf Complex Recalled for Undeclared Sulfites

    Barlean's is recalling Olive Leaf Complex softgels due to undeclared sulfites. Sulfite levels do not exceed 10 ppm.

    Product
    Item FG 10106, Barlean s, Olive Leaf Complex, 120 Softgels per bottle. UPC 7 05875 70009 2. Item FG 10107, Barlean s, Olive Leaf Complex, 60 Softgels per bottle. UPC 7 05875 0008 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1369-2019·2019-05-22

    Barlean's CBD Hemp Oil Softgels Recalled for Undeclared Sulfites

    Barlean's is recalling two CBD hemp oil softgel products due to undeclared sulfites. Sulfite levels in the finished goods do not exceed 10 ppm.

    Product
    Item FG 10191, Barlean s Ideal CBD Hemp Oil Softgel, 900 mg CBD, Less than 0.3% THC, 60 Softgels per bottle. UPC 7 05875 80112 6. Item FG 10194, Barlean s Ideal CBD Hemp Oil softgel, 750 mg CBD, Less than 0.3% THC, 30 Softgels per bottle. UPC 7 05875 80114 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1366-2019·2019-05-22

    Arrow PICC Recall for Incorrect Length Labeling

    Arrow International is recalling 963 Arrow PICC kits because some are labeled with the wrong length, potentially leading to incorrect clinical use.

    Product
    Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1344-2019·2019-05-22

    MediPress Pneumatic Compression System Recalled for Lack of Clearance

    Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.

    Product
    MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Food)·F-1354-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Coconut Crunch Granola because the products may contain pieces of aluminum.

    Product
    Back Roads Granola: Coconut Crunch Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1358-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Nut Free Granola because the product may contain pieces of aluminum.

    Product
    Back Roads Granola: Nut Free Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1301-2019·2019-05-22

    DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1302-2019·2019-05-22

    CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination

    Unipharma, LLC is recalling CVS Health Children's Cough Syrup due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1341-2019·2019-05-22

    Siemens Artis Q Angiography Systems Recalled for Tabletop Movement Blockage

    Siemens Medical Solutions is recalling 459 Artis Q angiography systems because the floating tabletop movement may be blocked after a collision sensor activates.

    Product
    Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1368-2019·2019-05-22

    Barlean's Full Spectrum Hemp Extract Recalled for Undeclared Sulfites

    Barlean's is recalling Full Spectrum Hemp Extract softgels due to undeclared sulfites. Sulfite levels do not exceed 10 ppm.

    Product
    Item FG 10190, Barleans Full Spectrum Hemp Extract, 60 Softgels per bottle. UPC 7 05875 80113 3. Item FG 10193, Barleans Full Spectrum Hemp Extract, 30 Softgels per bottle. UPC 7 05875 80115 7.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1348-2019·2019-05-22

    MediPress Pneumatic Compression System Recalled for Lack of Clearance

    Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.

    Product
    MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1345-2019·2019-05-22

    MediPress Pneumatic Compression System Recalled for Missing Premarket Clearance

    Compass Health Brands is recalling MediPress pneumatic compression systems because a product design change lacked proper FDA premarket clearance.

    Product
    MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Food)·F-1349-2019·2019-05-22

    Glorybee Raw California Orange Blossom Honey Recalled for Unapproved Fumagillin Residue

    Glorybee Natural Sweeteners is recalling Raw California Orange Blossom Honey because FDA samples tested positive for unapproved fumagillin residue.

    Product
    Item #13898 Raw California Orange Blossom Honey, packaged in an 18 oz jar with gold metal lid. Retail Jar UPC: 0 30042 00305 9. Item #13899 Raw California Orange Blossom Honey packaged in a case with 6 / 18 oz jars with gold metal lids. Case UPC: 0 30042 00338 7. The label
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1365-2019·2019-05-22

    Arrow PICC Recall for Incorrect Length Labeling

    Arrow International Inc. is recalling Arrow PICC kits because some may contain a different length than labeled.

    Product
    Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1353-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling Original Granola nationwide because the product may contain pieces of aluminum.

    Product
    Back Roads Granola: Original Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1362-2019·2019-05-22

    Barlean's Fish Oil Recalled for Undeclared Sulfites

    Barlean's is recalling Ultra EPA-DHA Fish Oil softgels due to undeclared sulfites. Sulfite levels are below 10 ppm.

    Product
    Item FG 10085, Barleans, Ultra EPA-DHA Fish Oil 1,300 mg Omega-3 Orange Flavor, 60 Softgels per bottle. UPC 7 05875 61006 3.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1296-2019·2019-05-22

    CVS Children's Acetaminophen Recalled for Potential B. cepacia Contamination

    Unipharma is recalling CVS Health Children's Pain & Fever Acetaminophen single-use vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1366-2019·2019-05-22

    Barlean's Essential Woman Softgels Recalled for Undeclared Sulfites

    Barlean's is recalling Essential Woman softgels due to undeclared sulfites. Sulfite levels in the finished goods do not exceed 10 ppm.

    Product
    Item FG 10146, Barlean s, Essential Woman, 120 count Softgels per bottle, UPC 7 05875 10013 7. Item FG 10147, Barlean s, Essential Woman, 60 count Softgels per bottle, UPC 7 05875 10009 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1299-2019·2019-05-22

    DrKids Children's Pain & Fever Oral Solution Recalled for B. cepacia Risk

    Unipharma, LLC is recalling 280 cartons of DrKids Children's Pain & Fever Oral Solution due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1361-2019·2019-05-22

    Barlean's Ultra EPA Fish Oil Recalled for Undeclared Sulfites

    Barlean's is recalling Ultra EPA Fish Oil softgels due to undeclared sulfites. Sulfite levels in the finished goods do not exceed 10 ppm.

    Product
    Item FG 10084, Barlean s, Ultra EPA Fish Oil 1250 mg Omega-3, 60 softgels per bottle, UPC 7 05875 61005 6.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1304-2019·2019-05-22

    CVS Health Children's Nasal Saline Drops Recalled for B. cepacia Risk

    Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1350-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Ancient Grains Granola because the products may contain pieces of aluminum.

    Product
    Back Roads Granola: Ancient Grains Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1363-2019·2019-05-22

    Barlean's Fish Oil Recalled for Undeclared Sulfites

    Barlean's is recalling specific bottles of Fish Oil Omega-3 EPA/DHA Orange Flavor due to undeclared sulfites. The product was distributed nationwide.

    Product
    Item FG 10089, Barlean s, Fish Oil Omega-3 EPA/DHA Orange Flavor, 100 Softgels per bottle. UPC 7 05875 61007 0. Item FG 10090, Barlean s, Fish Oil Omega-3 EPA/DHA Orange Flavor, 250 Softgels per bottle. UPC 7 05875 61008 7.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1352-2019·2019-05-22

    Back Roads Gluten-Free Granola Recalled for Aluminum Contamination

    Back Roads Food Company is recalling specific lots of Gluten-Free Granola because the products may contain pieces of aluminum.

    Product
    Back Roads Granola: Gluten Free Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1371-2019·2019-05-22

    Barlean's Flax Oil Supplements Recalled for Undeclared Sulfites

    Barlean's is recalling specific flax oil softgel supplements due to undeclared sulfites. The FDA classifies this as a Class III recall.

    Product
    Item FG 10079, Barleans, Flax Oil, 100 Softgels per bottle. UPC 7 05875 1007 6. Item FG 10081, Barleans, Lignan Flax Oil, 250 Softgels per bottle. UPC 7 05875 10008 3. Item FG 70000, Barlean's, Pure Flax Oil, 45 Softgels per bottle, label in English and Bulgarian. UPC 7 05
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1356-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling Maple Pecan Granola because it may contain pieces of aluminum.

    Product
    Back Roads Granola: Maple Pecan Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1365-2019·2019-05-22

    Barlean's Master Blend Omega 3.6.9 Recalled for Undeclared Sulfites

    Barlean's is recalling Master Blend Total Omega 3.6.9 Lemonade Flavor softgels due to undeclared sulfites. The product was distributed nationwide.

    Product
    Item FG 10116, Barlean s, Master Blend Total Omega 3.6.9 Lemonade Flavor, 90 Softgels per bottle. UPC 7 05875 10020 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1297-2019·2019-05-22

    CVS Health Children's Mucus Relief Recalled for B. cepacia Contamination Risk

    Unipharma, LLC is recalling CVS Health Children's Mucus Relief Chest Congestion Plus Cough due to potential contamination with B. cepacia bacteria.

    Product
    CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-26
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1329-2019·2019-05-22

    Fungitell Kit Recalled for Missing or Incorrect Components

    Associates of Cape Cod, Inc. is recalling Fungitell Kits due to potential missing or incorrect components.

    Product
    Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1338-2019·2019-05-22

    Integra Flowable Wound Matrix Recalled for Stability Failure

    Integra Limited is recalling 274 units of Integra Flowable Wound Matrix (Lot 2991332) because the product failed stability testing for visual appearance and force displacement.

    Product
    Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehisce
    Category
    Medical Device
    Distribution
    Distributed nationwide

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