The Recall Desk

Archive

August 2018 recalls

863 recalls were announced in August 2018.

What the numbers show

Critical
26
Severe
214
High
393
Moderate
191
Low
39

Of the 863 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

201–300 of 863

  • HighFDA (Food)·F-1827-2018·2018-08-22

    BulkSupplements.com Recalls Glucosamine Sulfate Potassium for Undeclared Shellfish

    Hard Eight Nutrition LLC is recalling two lots of Glucosamine Sulfate Potassium because the product labels failed to declare shellfish as an ingredient.

    Product
    BulkSupplements.com Glucosamine Sulfate Potassium; 100 grams, 250 grams, 500 grams, 1 kilogram; Stand up zipper pouch bags. Directions: As a dietary supplement, take 1000 mg (scant 1/4 tsp) up to three time daily, or as directed by a physician. Distributed exclusively by:
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2814-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets with NanoClave Manifold

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2816-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the luer and manifold.

    Product
    6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2813-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2794-2018·2018-08-22

    Mako Surgical Recalls Rio System Irrigation Clips Due to Tolerance Issues

    Mako Surgical Corporation is voluntarily recalling 10,606 Rio System Irrigation Clips because they are out of tolerance. The recall covers units distributed worldwide.

    Product
    Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and ref
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2805-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2787-2018·2018-08-22

    Wondfo Recalls TCube Oral Fluid Drug Test Cubes Due to Choking Hazard

    Guangzhou Wondfo Biotech is recalling 16,000 TCube One Step Multi-Drug Oral Fluid Test Cubes because the saliva collection device may fail, causing the foam tip to dislodge and create a choking hazard.

    Product
    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specif
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2789-2018·2018-08-22

    Wondfo Recalls T-Cube Oral Fluid Test Cubes Due to Choking Hazard

    Guangzhou Wondfo Biotech is recalling 50,000 T-Cube One Step Multi-Drug Oral Fluid Test Cubes because the saliva collection device may fail, causing the foam tip to dislodge in the user's mouth.

    Product
    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·18V555000·2018-08-22

    Kenworth Trucks Recalled for Missing Engine Warning Light Circuits

    PACCAR is recalling 2016-2019 Kenworth trucks because missing engine harness circuits may prevent warning lights from indicating serious engine problems.

    Product
    KENWORTH — KENWORTH W900, T800, C500, T660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2744-2018·2018-08-22

    ConvaTec AbViser AutoValve IAP Monitoring Devices Recalled for Sterile Barrier Breach

    ConvaTec is recalling AbViser AutoValve IAP Monitoring Devices because bubble leak testing confirmed a potential pinhole breach in the sterile barrier.

    Product
    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1797-2018·2018-08-22

    Saratoga Food Specialties Recalls Pizza Hut Seasoning Breadsticks Due to Salmonella Risk

    Saratoga Food Specialties is voluntarily recalling Pizza Hut Seasoning Breadsticks because a supplier recalled dry whey powder due to potential Salmonella presence.

    Product
    Pizza Hut Seasoning Breadstick 10 pound case, 5 X 2 lb. packages per case, Case SKU 6025584 UPC 1 0885251 71131 1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2792-2018·2018-08-22

    MegaPower Electrosurgical Generator Recalled for Potential Patient Burns

    Megadyne Medical Products is recalling 8,380 MegaPower Electrosurgical Generators because plugging two devices into the same port can activate both, potentially causing patient burns.

    Product
    MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2796-2018·2018-08-22

    Hamilton-C3 Ventilator Recalled Due to Control Board Component Defect

    Hamilton Medical AG is recalling two Hamilton-C3 ventilators because an out-of-specification control board component may cause the device to shut down and trigger alarms.

    Product
    Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward,
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1826-2018·2018-08-22

    Mediterranean Salad Vegan Recalled for Undeclared Milk Allergen

    Market of Choice Inc is recalling pre-packaged Mediterranean Salad Vegan because milk is listed in the ingredients but not in the 'Contains' statement.

    Product
    Mediterranean Salad Vegan, pre-packaged. UPC 0 211004 706991.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2808-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of 150 pouches of smallbore I.V. administration sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2803-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and manifold.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2819-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Issues

    Arrow International is recalling 5,507 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous she
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2802-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall for I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2807-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2829-2018·2018-08-22

    Withings Recalls Nokia BPM+ Wireless Blood Pressure Monitors

    Withings is recalling Nokia BPM+ Wireless Blood Pressure Monitors because the devices may not meet requirements for systolic pressure.

    Product
    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2828-2018·2018-08-22

    Cypress Medical Recalls Powder Free Vinyl Exam Gloves

    Cypress Medical Products LLC is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because samples failed release specifications, potentially compromising the barrier against infectious material.

    Product
    Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2806-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2747-2018·2018-08-22

    Siemens Artis Q. Angiography System Recalled for Potential Hardware Thermal Issue

    Siemens Medical Solutions is recalling 605 Artis Q. angiography systems due to a potential hardware issue that may cause thermal effects and damage to system parts.

    Product
    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2830-2018·2018-08-22

    Beekley O-SPOT REF 791 Mammography Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling O-SPOT REF 791 and 791S skin markers because they may create imaging artifacts that mimic calcifications on mammograms.

    Product
    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2804-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2746-2018·2018-08-22

    Mevion Medical Systems Recalls MEVION S250 Proton Beam Therapy Systems

    Mevion Medical Systems is recalling seven MEVION S250 and S250i proton beam therapy systems due to unauthorized accessory combinations that may cause patient injury.

    Product
    MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold.

    Product
    38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2790-2018·2018-08-22

    FDA Recalls Improve Blood Collection Sets Due to Needle Defects

    Guangzhou Improve Medical Instruments is recalling 700,000 blood collection sets in Puerto Rico due to needle defects including discoloration and gel agglomeration.

    Product
    Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·18V553000·2018-08-22

    Altec Recalls 2017-2018 LS63 Aerial Devices Due to Fuse Placement

    Altec is recalling 2017-2018 LS63 Aerial Devices because an incorrectly placed battery fuse may increase the risk of an electrical short and fire.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2800-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2823-2018·2018-08-22

    Merit Medical Recalls Pediatric Peritoneal Dialysis Catheters Due to Mix-Up

    Merit Medical Systems is recalling specific lots of Flex-Neck Classic Peritoneal Dialysis Catheters (Pediatric) due to a mix-up with adult catheters.

    Product
    Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2018·2018-08-22

    Tosoh HLC-723G8 Analyzer Recall Due to HbAE Interference

    Tosoh Bioscience is recalling 665 HLC-723G8 Automated HPLC Analyzers because Hemoglobin AE (HbAE) interferes with HbA1c results on Version 5.23 software.

    Product
    G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2809-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2815-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2798-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2795-2018·2018-08-22

    Hamilton-C1 Ventilator Recall Due to Control Board Component Defect

    Hamilton Medical AG is recalling 16 Hamilton-C1 ventilators because a defective control board component may cause the device to shut down and trigger alarms.

    Product
    Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2801-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2812-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2788-2018·2018-08-22

    Wondfo Recalls TCube Oral Fluid Test Cube Due to Choking Hazard

    Guangzhou Wondfo Biotech is recalling 60,000 units of the TCube One Step Multi-Drug Oral Fluid Test Cube because the saliva collection device may dislodge, creating a choking hazard.

    Product
    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qu
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2818-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Defects

    Arrow International Inc. is recalling 7,024 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous shea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1814-2018·2018-08-22

    Confidence Nitro-Cross 60s Recalled for Undeclared Ingredients

    Confidence Inc. is recalling Nitro-Cross 60s supplements due to undeclared ingredients including HPMC and Titanium Dioxide.

    Product
    FP0292 Confidence Nitro-Cross 60s, UPC# 8 92483 00155 7
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1815-2018·2018-08-22

    Confidence Prenatal Multi-V + DHA Recalled for Undeclared Ingredients

    Confidence Inc. is recalling Prenatal Multi-V + DHA tablets because they contain undeclared ingredients, including HPMC and several food dyes.

    Product
    FP0692, Confidence, Prenatal Multi-V + DHA, 90 tablets per bottle, UPC# 8 10891 02056 4
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2821-2018·2018-08-22

    Zimmer Biomet Recalls Echo Hip Stems Due to Potential Component Comingle

    Zimmer Biomet is recalling 12 Echo Bi-Metric Hip Stems because they may have been mixed with a different model. The error could extend surgery time.

    Product
    ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2751-2018·2018-08-22

    Terumo CDI System 500 Monitor Recalled for H/Sat Module Self-Test Failure

    Terumo is recalling 128 CDI System 500 monitors because a subset of devices fail the automated H/Sat Color Chip Test. This failure disables the H/Sat module but does not cause device inaccuracy.

    Product
    Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2750-2018·2018-08-22

    Terumo CDI Blood Parameter Monitoring System 500 H/SAT Recalled for Self-Test Failures

    Terumo is recalling 128 CDI Blood Parameter Monitoring System 500 H/SAT units because a hybrid intensity shift causes the automated Color Chip Test to fail, disabling the H/Sat module.

    Product
    CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and tempera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2820-2018·2018-08-22

    Zimmer Biomet Recalls ARCOS Modular Revision Hip System Femoral Stems

    Zimmer Biomet is recalling 12 ARCOS Modular Revision Hip System femoral stems because they may have been mixed with Echo BI-Metric stems, potentially extending surgery time.

    Product
    ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1772-2018·2018-08-22

    Sunny Side Farms Ice Cream Recalled for Flavor Mismatch

    Super Store Industries is recalling Sunny Side Farms Peanut Butter Cup Ice Cream because some containers are filled with Butter Pecan ice cream.

    Product
    Sunny Side Farms Peanut Butter Cup Ice Cream; 48 oz. carton, 1.5 QTS (1.42L) UPC: 7-17544-20740 5 Allergens for Peanut Butter Cup: Milk, Peanuts, Soy, Coconut. Allergens for Butter Pecan: Milk, Pecans Both packages include the following statement: While best practic
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2743-2018·2018-08-22

    Apollo Lap-Band System Recalled Due to Missing Component

    Apollo Endosurgery Inc. is recalling 54 units of the Apollo Lap-Band AP System Small with RapidPort EZ because a component was missing from the package.

    Product
    Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2742-2018·2018-08-22

    Merit Medical Systems Recalls 1mL Medallion Syringes Due to Plunger Defect

    Merit Medical Systems is recalling 22,234 units of 1mL Medallion Syringes due to a manufacturing defect in the plunger tip.

    Product
    1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1823-2018·2018-08-22

    Severino Cheese Raviolini Recalled for Undeclared Eggs on Bottom Label

    Severino Pasta Manufacturing is recalling Cheese Raviolini because the bottom label incorrectly identifies the product as Rigatoni and omits eggs, creating an allergen mislabeling risk.

    Product
    Severino Home Made, Artisanal Small Batch Pasta, Raviolini Cheese, 9 units x 9 oz per case. Expiration March 2019.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1079-2018·2018-08-22

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's is recalling 40 mg Atorvastatin Calcium tablets because stability testing showed impurity levels exceeding specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2835-2018·2018-08-22

    Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Defect

    Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller due to improper calibration. The defect may cause dim images, color imbalance, or increased fogging.

    Product
    The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2836-2018·2018-08-22

    DRG Instruments Recalls Salivary Estradiol ELISA Kits Due to Measurement Errors

    DRG Instruments GmbH is recalling 169 Salivary Estradiol ELISA kits because poor differentiation between standards may cause lower recovery of estradiol levels.

    Product
    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2822-2018·2018-08-22

    Nico Corp. Recalls Mislabeled Sterile Shepherd's Hook Accessories

    Nico Corp. is recalling 204 sterile Shepherd's Hook accessories because they were shipped with incorrect transport labels instead of product labels.

    Product
    NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2748-2018·2018-08-22

    Siemens ARTIS Pheno X-Ray System Recalled for Potential Hardware Thermal Issue

    Siemens Medical Solutions USA is recalling 605 ARTIS Pheno interventional fluoroscopic X-ray systems due to a potential hardware issue that may cause thermal effects and damage to system parts.

    Product
    ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis 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
  • LowFDA (Drugs)·D-1099-2018·2018-08-22

    FDA Recalls Contrave Tablets Due to Punctured Bottle Complaints

    Orexigen Therapeutics is recalling 95,296 bottles of Contrave extended-release tablets due to customer complaints of punctures in the bottles.

    Product
    CONTRAVE — CONTRAVE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1831-2018·2018-08-22

    Prana Biovegan Organic Dried Figs Recalled for Insects

    Prana Biovegan Inc. is recalling Organic Dried Figs because the product may contain insects. The recall affects specific lots distributed to Pennsylvania and Massachusetts.

    Product
    Organic Dried Figs 6X16oz (454g), UPC 8 77693 00850 3
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-2786-2018·2018-08-22

    Clarity 10SG Urinalysis Strips Recalled for Analyzer Incompatibility

    Clarity Diagnostics is recalling specific lots of Clarity 10SG Urinalysis Strips because they lack a Canister Code Bar Code Label, making them incompatible with Clarity Urocheck 120 Urine Analyzers.

    Product
    Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1816-2018·2018-08-22

    Confidence Glucosamine Plus Recalled for Undeclared Ingredients

    Confidence Inc. is recalling Glucosamine Plus tablets because they contain undeclared ingredients, including Hydroxypropyl Methylcellulose and Titanium Dioxide.

    Product
    FP0391 Confidence, Glucosamine Plus, With Hyaluronic Acid + Curcumin & Boswellia, 60 Extended Release Tablets, UPC: 8 92483 00106 9
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1813-2018·2018-08-22

    Confidence Glucosamine Plus Recalled for Undeclared Ingredients

    Confidence Inc. is recalling Glucosamine Plus tablets because they contain undeclared ingredients, including Hydroxypropyl Methylcellulose and Titanium Dioxide.

    Product
    FP0392, Confidence, Glucosamine Plus, with White Willow Bark & Boswella, 90 Extended Release Tablets, UPC# 8 10891 02253 7
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2827-2018·2018-08-22

    Tosoh Bioscience Recalls AIA Analyte Application Manual CDs

    Tosoh Bioscience is recalling 9 AIA Analyte Application Manual CDs due to unapproved product labeling. The CDs were distributed to six US states.

    Product
    Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference sect
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-1076-2018·2018-08-22

    Acne Treatment Pads Recalled for Subpotent Salicylic Acid Levels

    Huijing (Shanghai) Bio-tech Co., Ltd. is recalling Acne Treatment Pads because the active ingredient level does not match the label.

    Product
    Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2749-2018·2018-08-22

    Richard-Allan Scientific Recalls Mislabeled EZ Single Cytofunnel Brown Units

    Richard-Allan Scientific is recalling 1,039 cases of EZ Single Cytofunnel Brown units due to mislabeling. The recall is voluntary and nationwide.

    Product
    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·068-2018·2018-08-21

    Taylor Farms Recalls Meatloaf Due To Undeclared Allergens

    Taylor Farms Northwest is recalling 62 pounds of ready-to-eat meatloaf containing undeclared fish and milk allergens. The products were distributed in Oregon and Washington.

    Product
    Taylor Farms Northwest LLC — Taylor Farms Northwest, LLC Recalls Ready-To-Eat Meatloaf Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·18198·2018-08-21

    Confer Plastics Recalls Pool Step Systems Due to Entrapment Hazard

    Confer Plastics is recalling Curve in-pool step systems because children's limbs can become entrapped in side openings, posing a drowning risk.

    Product
    Curve in-pool step systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V551000·2018-08-21

    Nissan and Chevrolet Recall for Ignition Switch Stalling Risk

    Nissan is recalling 2017-2018 models including the Versa, Sentra, and NV200 because the ignition switch may shift, causing the engine to stall and increasing crash risk.

    Product
    NISSAN — NISSAN, CHEVROLET VERSA NOTE, NV200 TAXI, VERSA, CHEVEROLET SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V548000·2018-08-20

    Ford Recalls 2018-2019 Vehicles for Electrical Arc Fire Risk

    Ford is recalling 2018-2019 Edge, Flex, MKX, and MKT vehicles because improperly secured power supply cables may cause an electrical arc, increasing the risk of a fire.

    Product
    FORD — FORD, LINCOLN EDGE, MKX, MKT, FLEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V537000·2018-08-20

    Volkswagen Recalls 2018 Atlas Vehicles Due to Air Bag Control Module Risk

    Volkswagen is recalling 2018 Atlas vehicles because a twisted air conditioning drain tube may allow water to enter the air bag control module, potentially causing unintentional air bag deployment.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18E085000·2018-08-20

    Allison Transmission Recall for Potential Loss of Drive

    Allison is recalling certain H 50 and H 40 Drive Units because pressure switches may fail, causing a loss of drive and increasing crash risk.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V545000·2018-08-17

    2019 Coachmen Freedom Express Recalled for Brake Wiring Defect

    Forest River is recalling 2019 Coachmen Freedom Express trailers because the break-away safety switch may not engage brakes if the trailer detaches.

    Product
    COACHMEN — COACHMEN FREEDOM EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V546000·2018-08-17

    Winnebago Recalls 2016-2019 Motorhomes Due to Unfused Solar Charging Circuit

    Winnebago is recalling 2016-2019 motorhomes because an unfused auxiliary solar charging circuit can increase the risk of fire if solar panels exceed the circuit's amperage capacity.

    Product
    WINNEBAGO — WINNEBAGO TREND, PASEO, JOURNEY, ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18760·2018-08-17

    Polaris Recalls ACE 150 and Ranger 150 Vehicles Due to Crash Hazard

    Polaris is recalling about 5,900 ACE 150 and Ranger 150 recreational off-highway vehicles because the front suspension lower ball joint can separate, posing a crash hazard.

    Product
    Model year 2017-2018 Polaris ACE 150 and model year 2018 Polaris Ranger 150 recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V542000·2018-08-16

    Volvo Recalls 2019 VNL and VNR Trucks for Fifth Wheel Defect

    Volvo is recalling 2019 VNL and VNR trucks because a narrow fifth wheel bracket may allow the trailer to separate from the tractor, increasing crash risk.

    Product
    VOLVO — VOLVO VNL, VNR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V539000·2018-08-16

    Mercedes-Benz Recalls 2018 GLE and GLS Models for Brake Defect

    Mercedes-Benz is recalling 9,044 2018 GLE and GLS vehicles because rear brake caliper pistons may release gas, reducing braking performance.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLS 450, AMG GLE63S, GLS 550, GLE 350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V543000·2018-08-16

    Mack Recalls 2019 Anthem Trucks Due to Fifth Wheel Bracket Defect

    Mack Trucks is recalling 2019 Anthem trucks with Jost fifth wheel couplings because a narrow slider bracket may allow the trailer to separate, increasing crash risk.

    Product
    MACK — MACK ANTHEM (AN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·18V540000·2018-08-16

    KZRV Recalls 2017-2019 Trailers Due to Incorrect Tire Size Label

    KZRV is recalling 2017-2019 Durango, Venom, and Sidewinder trailers because the Federal Certification label lists the wrong tire size, which could lead to incorrect tire installation.

    Product
    KZRV — KZRV SIDEWINDER, VENOM, DURANGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1125-2018·2018-08-15

    World Organix Recalls Blissful Remedies Capsules for Microbial Contamination

    World Organix LLC is recalling Blissful Remedies Gold Series Ultra Enhanced Indo capsules due to potential high microbial loads.

    Product
    Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1760-2018·2018-08-15

    Lipari Foods Recalls Turkey and Swiss Submarine Sandwiches for Listeria Risk

    Lipari Foods is voluntarily recalling Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches, 4/6 oz, and 18/6 oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1742-2018·2018-08-15

    Whole Foods Bakery Products Recalled for Undeclared Soy Flour

    Whole Foods Market is recalling bakery products sold in the Mid-Atlantic region between May 25 and July 13 because they failed to declare soy flour as an ingredient.

    Product
    CAKE TOASTED ALMOND 6 IN, 29.6 Ounce CAKE TOASTED ALMOND 9IN, 64.0 Ounce
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1834-2018·2018-08-15

    Sweet Earth Aloha BBQ Quesadilla Recalled for Undeclared Allergens

    Sweet Earth Inc. is recalling Aloha BBQ Quesadillas because some packages contain Mile High Quesadillas with undeclared eggs and milk.

    Product
    Sweet Earth Foods Aloha BBQ Quesadilla; 2 pack, NET WT 8 oz. Vegan: Pinto Beans, Red Onions, Pineapple and jalapenos with our vegan BBQ grounds and a cheddar-style vegan cheese. Keep Frozen. Ingredients: Filling: Vegan BBQ savory grounds (water, vital wheat gluten, onion,
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1930-2018·2018-08-15

    Hy-Vee Spring Pasta Salad Recalled for Salmonella Illness Risk

    D & D Foods, Inc. is recalling Hy-Vee Spring Pasta Salad due to an outbreak of Salmonella Sandiego and Salmonella enterica subspecies IIIb illness potentially associated with the product.

    Product
    Hy-Vee Spring Pasta Salad packaged in the following containers: 1) plastic tubs with lids, Net Wt 16 OZ (454 g); 2) plastic tubs with lids, Net Wt 48 OZ (3 LB) 1.36 kg; 3) 4/8 lb cases Net Wt 32.00 LBS (14.51 KG); 4) 8 lb cases Net WT. 8.00 LBS (3.63 KG); 5) 11 lb Spring Salad Ki
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2690-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 269 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1123-2018·2018-08-15

    World Organix Recalls Blissful Remedies Herbal Shot Due to Microbial Contamination

    World Organix, LLC is recalling Blissful Remedies 4 Hour Chill herbal shots due to potential high microbial loads. The affected products were distributed nationwide.

    Product
    Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1070-2018·2018-08-15

    Guardian Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 100 vials of compounded Glutathione 200 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2686-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 303 rHead Recon Stem Implant Plasma Coated, Size 2 units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1124-2018·2018-08-15

    World Organix Recalls Blissful Remedies Liquid Kratom for Microbial Contamination

    World Organix, LLC is recalling Blissful Remedies Red Maeng Da Liquid Kratom due to potential high microbial loads. The product was distributed nationwide in the USA.

    Product
    Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1126-2018·2018-08-15

    World Organix Recalls Kratom and CBD Capsules for Microbial Contamination

    World Organix LLC is recalling Blissful Remedies Kratom+CBD capsules due to potential high microbial loads. The affected products were distributed nationwide.

    Product
    Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1122-2018·2018-08-15

    World Organix Recalls Blissful Remedies Red Maeng Da Capsules for Microbial Contamination

    World Organix, LLC is recalling Blissful Remedies Red Maeng Da capsules due to potential high microbial loads. The recall covers 789 pouches distributed nationwide.

    Product
    Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1745-2018·2018-08-15

    Whole Foods Recalls Lemon Raspberry Cake for Undeclared Soy

    Whole Foods Market is recalling Lemon Raspberry Cake made in Mid-Atlantic stores because it failed to declare soy flour as an ingredient.

    Product
    CAKE LEMON RASPBERRY
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1073-2018·2018-08-15

    Guardian Pharmacy Recalls Phenol 6% Injection Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 40 vials of Phenol 6% with Glycerin Injection in Texas due to a lack of sterility assurance.

    Product
    Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V532000·2018-08-15

    Winnebago and Itasca Motorhomes Recalled for Propane Hose Leak Risk

    Winnebago is recalling 2012-2013 Era, View, Via, Itasca Navion, and Reyo motorhomes because high-pressure propane hoses may harden and leak, increasing fire risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VIEW, REYO, VIA, ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1051-2018·2018-08-15

    Guardian Pharmacy Recalls Morphine Sulfate CADD Due to Sterility Concerns

    Guardian Pharmacy Services is recalling specific lots of compounded Morphine Sulfate 1 mg/mL CADD 25 mL due to a lack of sterility assurance.

    Product
    Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2553-2018·2018-08-15

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk

    Vyaire Medical is recalling 15,714 pediatric AirLife Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.

    Product
    AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric,
    Category
    Medical Device
    Distribution
    28 states

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