The Recall Desk

Archive

July 2019 recalls

903 recalls were announced in July 2019.

What the numbers show

Critical
24
Severe
150
High
252
Moderate
463
Low
14

Of the 903 recalls this month scored against our rubric, 3% are Critical, 17% are Severe.

Which agencies issued them

801–900 of 903

  • SevereFDA (Drugs)·D-1425-2019·2019-07-03

    Premier Pharmacy Labs Recalls Riboflavin 5-Phosphate Sodium Ophthalmic Solution

    Premier Pharmacy Labs is recalling 125 bottles of Riboflavin 5-Phosphate Sodium Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1419-2019·2019-07-03

    Premier Pharmacy Labs Recalls Lidocaine and Phenylephrine Injection Vials

    Premier Pharmacy Labs is recalling 323 vials of Lidocaine 0.5%/Phenylephrine 0.75% Injection due to a lack of sterility assurance identified during an FDA inspection.

    Product
    Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-176-31, barcode 6 69623 17631 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1427-2019·2019-07-03

    Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns

    Premier Pharmacy Labs is recalling 6,423 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-15, barcode 0 69623 23915 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1411-2019·2019-07-03

    Premier Pharmacy Labs Recalls Atropine Sulfate Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 745 syringes of Atropine Sulfate Injection because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1422-2019·2019-07-03

    Premier Pharmacy Labs Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns

    Premier Pharmacy Labs is recalling Neostigmine Methylsulfate syringes nationwide due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1417-2019·2019-07-03

    Premier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 1,235 bags of Isoproterenol HCL in D5W nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.

    Product
    Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-240-57, barcode 0 69623 24057 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1426-2019·2019-07-03

    Premier Pharmacy Labs Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 13,150 vials of Sodium Bicarbonate Injection 8.4% nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.

    Product
    Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-232-39, barcode 8 69623 23239 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1430-2019·2019-07-03

    Diphenhydramine Liquid Recalled for Potential Microbial Contamination

    H J Harkins Company is recalling Diphenhydramine HCL Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1433-2019·2019-07-03

    Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and a cleaning procedure failure that may have caused cross-contamination.

    Product
    Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1889-2019·2019-07-03

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk

    Ethicon is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to a reported incidence of intraoperative bleeding.

    Product
    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1416-2019·2019-07-03

    Premier Pharmacy Labs Recalls Isoproterenol Bags Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 606 bags of Isoproterenol HCL in D5W because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1428-2019·2019-07-03

    Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns

    Premier Pharmacy Labs is recalling 1,721 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1531-2019·2019-07-03

    Mai Spicy Shrimp Tempura Roll Recalled for Undeclared Egg

    Mai Cuisine LLC is recalling 22 packages of Spicy Shrimp Tempura Roll in Oregon due to undeclared egg.

    Product
    Spicy Shrimp Tempura Roll, Mai brand, packed in container with clear plastic lid, net wt. 8 oz., UPC 8 12824 01525 8. The label is read in parts: "***MAI SPICY SHRIMP TEMPURA ROLL **KEEP REFRIGERATED***Allergen: SOY, WHEAT, SHELLFISH***"dist by Mai Sushi 2 Penn Center, Suite 7
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1434-2019·2019-07-03

    American Health Packaging Recalls Pramipexole Dihydrochloride Tablets Due to GMP Deviations

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.

    Product
    Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1423-2019·2019-07-03

    Premier Pharmacy Labs Recalls Orphenadrine Citrate Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 4,363 syringes of Orphenadrine Citrate Sterile Injectable Solution because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-104-10, barcode 7 69623 10410 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1418-2019·2019-07-03

    Premier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 40 bags of Isoproterenol HCL in D5W due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-107-57, barcode 3 69623 10757 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1530-2019·2019-07-03

    Mai Cuisine Recalls Spicy Shrimp Tempura Crunch Roll for Undeclared Egg

    Mai Cuisine LLC is recalling 35 packages of Spicy Shrimp Tempura Crunch Roll distributed in Oregon due to undeclared egg.

    Product
    Spicy Shrimp Tempura Crunch Roll, Mai brand, packed in container with clear plastic lid,net wt. 9.1 oz., UPC 8 12824 01526 5. The label is read in parts: "***MAI SPICY SHRIMP TEMPURA CRUNCH ROLL ***KEEP REFRIGERATED***Allergen: SOY, WHEAT, SHELLFISH***"dist by Mai Sushi 2 Pen
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1494-2019·2019-07-03

    Hank's Key Lime Cheesecakes Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling 207 Key Lime Cheesecakes because they were distributed without labels indicating ingredients or major food allergens.

    Product
    Key Lime Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1511-2019·2019-07-03

    Hank's Chocolate Swirl Cheesecake Recalled for Missing Allergen Labels

    Hank's Cheesecakes, LLC is recalling 207 Chocolate Swirl Cheesecakes because they were distributed without labels indicating ingredients or major food allergens.

    Product
    Chocolate Swirl Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·19V512000·2019-07-03

    Winnebago Forza Motorhomes Recalled for Storage Door Defect

    Winnebago is recalling 2017-2019 Forza motorhomes because the exterior storage compartment door may unexpectedly open while driving, increasing crash risk.

    Product
    WINNEBAGO — WINNEBAGO FORZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2019·2019-07-03

    Becton Dickinson Recalls SmartSite Syringe Administration Sets Due to Leaking

    Becton Dickinson is recalling SmartSite Syringe Administration Sets because they may leak, potentially interrupting infusions or exposing healthcare workers to fluids.

    Product
    SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling four units of the General Purpose Dynamic Bath due to an assembly error that may cause the fluid temperature to rise above the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1499-2019·2019-07-03

    Hank's Cheesecake Strawberry Cheesecake Recalled for Missing Allergen Labels

    Hank's Cheesecakes, LLC is recalling 207 Strawberry Cheesecakes distributed in Missouri and Illinois because they lack labels indicating ingredients and major food allergens.

    Product
    Strawberry Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1502-2019·2019-07-03

    Hank's Caramel Macchiato Cheesecakes Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling Caramel Macchiato Cheesecakes because they lack labels indicating ingredients and major food allergens.

    Product
    Caramel Macchiato Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1485-2019·2019-07-03

    Classic Salads Recalls Baby Greens Due to Salmonella Risk

    Classic Salads, LLC is recalling 75 cartons of Baby Greens in Connecticut and New Jersey after a pre-harvest field test tested positive for Salmonella.

    Product
    Classic Salads 5067PF Baby Greens Conv NordicBlend 4x3# Pillow Pack Peak Fresh 344; 5067 Baby Green Conv NordicBlend 4x3# Pillow Pack Classic 344 3 lb bags; Brand names of Peak Fresh and Classic Salads
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1510-2019·2019-07-03

    Hank's Cheesecakes Recalls Chocolate Raspberry Cakes for Missing Allergen Labels

    Hank's Cheesecakes, LLC is recalling 207 chocolate raspberry cakes because they were distributed without labels indicating ingredients or major food allergens.

    Product
    Chocolate Raspberry Cake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·19E044000·2019-07-03

    DLT Recalls CravenSpeed Fiat Short Shifter Shafts for Breakage Risk

    DLT, LLC is recalling CravenSpeed Fiat Short Shifter shafts for 2011-2019 Fiat 500 vehicles because improper manufacturing may cause the shaft to break, increasing crash risk.

    Product
    FIAT — FIAT 500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling six VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1876-2019·2019-07-03

    GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk

    GE Healthcare is recalling ECG leadwire sets because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.

    Product
    ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1514-2019·2019-07-03

    Hank's Neapolitan Cheesecakes Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling Neapolitan cheesecakes because the packaging lacks ingredient and major food allergen labels.

    Product
    Neapolitan Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1503-2019·2019-07-03

    Hank's Cheesecakes Recalls Triple Play Cake Due to Missing Allergen Labels

    Hank's Cheesecakes, LLC is recalling 207 Triple Play Cakes because the packaging lacks ingredient and major food allergen information.

    Product
    Triple Play Cake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1871-2019·2019-07-03

    Thermo Scientific Dual GP Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling four Thermo Scientific General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1504-2019·2019-07-03

    Hank's Double Chocolate Cheesecake Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling Double Chocolate Cheesecakes because the packaging lacks ingredient and major food allergen information.

    Product
    Double Chocolate Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1853-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 11 VOLISTA StandOP Surgical Lights because coating on the light head forks may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1513-2019·2019-07-03

    Hank's Irish Cream Cheesecake Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling Irish Cream Cheesecakes because the packaging lacks ingredient and major food allergen information.

    Product
    Irish Cream Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1890-2019·2019-07-03

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk

    Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.

    Product
    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1501-2019·2019-07-03

    Hank's Cheesecake Recalls Chocolate Amaretto Torte for Missing Allergen Labels

    Hank's Cheesecakes, LLC is recalling 207 Chocolate Amaretto Tortes because the packaging lacks ingredient and major food allergen information.

    Product
    Chocolate Amaretto Torte in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1872-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling three General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model Number: TSGP28
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1868-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling 12 General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to exceed the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1522-2019·2019-07-03

    Euphoria Trading Recalls 70% Dark Chocolate Buttons for Undeclared Soy

    Euphoria Trading Company is recalling 70% Dark Chocolate Buttons due to undeclared soy lecithin. The product was distributed in Oregon.

    Product
    70% Dark Chocolate Buttons packaged in cellophane bags, zip bags (plastic bag with Ziploc closure), a bulk bin in the factory store. Net wt. 3 oz., 8 oz., 16 oz., 3 lbs (48 oz.) UPC on 3 oz. bag: 0 50469 05423 UPC on 8 oz. bag: 0 50469 05424 or 0 50469 05497 UPC on 16 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1497-2019·2019-07-03

    Hank's Cheesecakes Recalls Chocolate Cakes Lacking Allergen Labels

    Hank's Cheesecakes, LLC is recalling 207 chocolate cakes because they were distributed without labels indicating ingredients or major food allergens.

    Product
    Chocolate Cake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1865-2019·2019-07-03

    Thermo Fisher Water Bath Recall Due to Assembly Error

    Thermo Fisher Scientific is recalling 10 Fisher Scientific Isotemp water baths because an assembly error may cause the fluid temperature to rise above the user's set point.

    Product
    Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1862-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head fork coating may crack, posing a risk of particles falling into the surgical field and causing patient infection.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2019·2019-07-03

    Thermo Fisher Isotemp Water Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling Isotemp 20L General Purpose Water Baths due to assembly errors that may cause the fluid temperature to exceed the user's set point.

    Product
    Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1873-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling two Thermo Scientific General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1887-2019·2019-07-03

    AtriCure EPi-Sense Guided Coagulation System Recalled for Compromised Sterile Seal

    AtriCure is recalling 497 units of the EPi-Sense Guided Coagulation System because the sterile package seal may be compromised, posing a risk of infection.

    Product
    EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 10 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, potentially dropping particles into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1507-2019·2019-07-03

    Hank's Blueberry Cheesecakes Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling 207 blueberry cheesecakes because they lack labels indicating ingredients and major food allergens.

    Product
    Blueberry Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1506-2019·2019-07-03

    Hank's Banana Cheesecake Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling 207 banana cheesecakes because they lack labels indicating ingredients and major food allergens.

    Product
    Banana Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1852-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled Due to Coating Crack Risk

    Maquet is recalling 65 VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field and causing patient infection.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling four General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1512-2019·2019-07-03

    Hank's Tiramisu Cheesecake Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling Tiramisu Cheesecakes because the packaging lacks ingredient and major food allergen information.

    Product
    Tiramisu Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1879-2019·2019-07-03

    GE Healthcare Recalls Replacement ECG Leadwires Due to Defibrillation Risk

    GE Healthcare is recalling 58,045 replacement ECG leadwires worldwide because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2019·2019-07-03

    GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk

    GE Healthcare is recalling specific ECG leadwire sets because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1508-2019·2019-07-03

    Hank's Dreamsicle Cheesecake Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling Dreamsicle Cheesecakes because the packaging lacks ingredient and major food allergen information.

    Product
    Dreamsicle Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1892-2019·2019-07-03

    Hitachi PROBEAT-V Proton Therapy System Software Recall

    Hitachi is recalling three PROBEAT-V proton therapy systems due to a potential software error that could result in incorrect target positioning during treatment.

    Product
    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1856-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 7 units of VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2019·2019-07-03

    GE Healthcare Recalls Centricity Universal Viewer for Missing Image Warning

    GE Healthcare is recalling 292 units of the Centricity Universal Viewer because it may fail to warn users when medical images are missing from exams.

    Product
    Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, com
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2019·2019-07-03

    GE Healthcare Recalls Centricity PACS-IW Universal Viewer Software

    GE Healthcare is recalling Centricity PACS-IW with Universal Viewer version 5.0 because medical images may be missing without warning.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled Due to Coating Crack Risk

    Maquet is recalling 46 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, risking particle contamination in the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1493-2019·2019-07-03

    Hank's Cheesecakes Recalled for Missing Allergen and Ingredient Labels

    Hank's Cheesecakes, LLC is recalling plain cheesecakes distributed in Missouri and Illinois because the packages lack labels indicating ingredients or major food allergens.

    Product
    Plain Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1857-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2019·2019-07-03

    GE Healthcare Recalls ECG Leadwires Due to Defibrillation Energy Reduction

    GE Healthcare is recalling 58,045 replacement ECG leadwires because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.

    Product
    Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 12 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 11 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1496-2019·2019-07-03

    Hank's Cheesecakes Recalls Unlabeled Carrot Cakes for Missing Allergen Info

    Hank's Cheesecakes, LLC is recalling 207 carrot cakes sold in Missouri and Illinois because the packaging lacks ingredient and allergen labels.

    Product
    Carrot Cake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1500-2019·2019-07-03

    Hank's Cheesecakes Recalled for Missing Allergen and Ingredient Labels

    Hank's Cheesecakes, LLC is recalling 207 LoRusso Cakes because they were distributed without labels indicating ingredients or major food allergens.

    Product
    LoRusso Cake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1863-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 9 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling five VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2019·2019-07-03

    Thermo Fisher Isotemp Water Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling five Isotemp 10L General Purpose Water Baths due to an assembly error that may cause the fluid temperature to rise above the set point.

    Product
    Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1498-2019·2019-07-03

    Hank's Cheesecakes Recalls Turtle Cheesecakes Lacking Allergen Labels

    Hank's Cheesecakes, LLC is recalling 207 Turtle Cheesecakes because they were distributed without labels indicating ingredients or major food allergens.

    Product
    Turtle Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1517-2019·2019-07-03

    Full Circle Market Garden Style Salsa Recalled for Foreign Material

    Simply Fresco LLC is recalling 54 cases of Full Circle Market Garden Style Salsa, Medium, 16 oz jars, due to potential foreign material up to 3 mm in diameter.

    Product
    Full Circle Market Garden Style Salsa, Medium, Net Wt 16 oz, in jars, 8 jars per case.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1431-2019·2019-07-03

    Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to cleaning procedure failures that may have caused cross-contamination.

    Product
    Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1875-2019·2019-07-03

    GE Healthcare Recalls ECG Trunk Cables Due to Defibrillation Risk

    GE Healthcare is recalling ECG trunk cables that may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2019·2019-07-03

    Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with incorrect sizes. The actual valves are larger than indicated on the packaging.

    Product
    Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1432-2019·2019-07-03

    Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk

    American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.

    Product
    Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1515-2019·2019-07-03

    Hank's Cheesecakes Recalls Cream Cheese Brownies for Missing Allergen Labels

    Hank's Cheesecakes, LLC is recalling Cream Cheese Brownies because the packaging lacks labels indicating ingredients or major food allergens.

    Product
    Cream Cheese Brownies in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1882-2019·2019-07-03

    Medtronic Hancock II Mitral Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Mitral Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1891-2019·2019-07-03

    Qiagen RNeasy DSP FFPE Kit Recalled Due to Contaminant

    Qiagen is recalling 31 units of the RNeasy DSP FFPE Kit because a contaminant in the deparaffinization solution reduces RNA purification efficiency.

    Product
    RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1516-2019·2019-07-03

    Full Circle Market Garden Style Salsa Recalled for Foreign Material

    Simply Fresco LLC is recalling Full Circle Market Garden Style Salsa, Mild, 16 oz jars due to potential foreign material up to 3 mm in diameter.

    Product
    Full Circle Market Garden Style Salsa, Mild, Net Wt 16 oz, in jars, 8 jars per case.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1884-2019·2019-07-03

    Medtronic Hancock II T510 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1881-2019·2019-07-03

    Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2019·2019-07-03

    Tecan Freedom EVO 200 Laboratory Robots Recalled for Gas Spring Maintenance

    Tecan US, Inc. is recalling 40 Freedom EVO 200 laboratory robots because gas springs were not always replaced within the specified interval.

    Product
    Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1883-2019·2019-07-03

    Medtronic Hancock II T510 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1386-2019·2019-07-03

    Vyaire Medical Recalls enFlow Disposable Cartridges Due to Aluminum Elution

    Vyaire Medical is recalling enFlow Disposable Cartridges with IV Extension Sets because testing showed aluminum elution during fluid warming.

    Product
    enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V508000·2019-07-02

    Altec Recalls 2018-2019 Aerial Devices Due to Fastener Failure Risk

    Altec is recalling 2018-2019 aerial devices because high-strength fasteners securing the pedestal to the turntable may fail, increasing the risk of injury or death.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V507000·2019-07-02

    Mercedes-Benz and Freightliner Sprinter Vehicles Recalled for Rear Window Safety Glass

    Daimler Vans USA is recalling 2018-2019 Mercedes-Benz and Freightliner Sprinter vans because rear side windows may be single-pane instead of laminated safety glass.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 1500, SPRINTER 2500, SPRINTER 4500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V509000·2019-07-02

    Volvo Trucks Recalls 2018-2020 Models Due to Transmission Fuse Defect

    Volvo Trucks is recalling 2018-2020 VAH, VHD, VNL, and VNR models because a fuse may blow, preventing the transmission from shifting and increasing crash risk.

    Product
    VOLVO — VOLVO VAH, VNR, VHD, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19157·2019-07-02

    SRAM Recalls RockShox Front Suspension Forks Due to Crash Hazards

    SRAM is recalling RockShox Lyrik and Yari front suspension forks because the lower leg assembly can break, causing riders to lose control and crash.

    Product
    RockShox Lyrik and RockShox Yari front suspension forks
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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