The Recall Desk

Archive

May 2018 recalls

1,113 recalls were announced in May 2018.

What the numbers show

Critical
47
Severe
301
High
429
Moderate
304
Low
32

Of the 1,113 recalls this month scored against our rubric, 4% are Critical, 27% are Severe.

601–700 of 1113

  • ModerateFDA (Drugs)·D-0862-2018·2018-05-16

    Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defect

    Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal systems because the adhesive may not meet specifications, causing patches to stick poorly to the skin.

    Product
    MINIVELLE — MINIVELLE (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1692-2018·2018-05-16

    PerkinElmer Recalls NeoBase Succinylacetone Assay Solution Due to Leaking Vials

    PerkinElmer is recalling NeoBase Succinylacetone Assay Solution because leaking vials may cause minor allergic skin reactions if proper attire is not used.

    Product
    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923…
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1632-2018·2018-05-16

    Michigan Instruments Recalls Thumper Cardiopulmonary Resuscitator Due to Valve Defect

    Michigan Instruments is recalling 38 Thumper Cardiopulmonary Resuscitators because a valve defect may prevent the device from delivering chest compression depth.

    Product
    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1409-2018·2018-05-16

    Eastland Recalls Asian Best Tamarind Candy Due to Lead Levels

    Eastland Food Corporation is recalling Asian Best Tamarind Candy due to lead levels exceeding FDA action levels.

    Product
    Asian Best, Tamarind Candy Net Weight: 4 oz. Units Per Carton: 72 units
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0745-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Repatha Due to Lack of Processing Controls

    Kroger Specialty Pharmacy is recalling Repatha 140 mg/mL Sureclick AI 2-pk due to lack of processing controls. The recall affects units dispensed in MS, LA, AR, IL, and FL.

    Product
    Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1760-2018·2018-05-16

    Bard POWERPORT ClearVUE Implantable Port Recalled for Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 359 units of POWERPORT ClearVUE implantable ports because the included patient ID card contains incorrect flushing instructions.

    Product
    POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0751-2018·2018-05-16

    Kroger Specialty Pharmacy Recalls Orkambi Tablets Due to Processing Controls

    Kroger Specialty Pharmacy is recalling Orkambi 100 mg/125 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

    Product
    Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1757-2018·2018-05-16

    Tornier Aequalis Humeral Nail Drill Bit Recall for Packaging Defect

    Tornier is recalling Aequalis Humeral Nail Drill Bits because the tips may puncture sterile packaging, potentially compromising sterility.

    Product
    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1744-2018·2018-05-16

    Hyphen BioMed Recalls ZYMUTEST HIA IgGAM Assay Kits Due to Incorrect Package Insert

    Hyphen BioMed is recalling 281 units of the ZYMUTEST HIA IgGAM assay because the package insert incorrectly states the kits can be used with serum and other fluids, when they should only be used with plasma.

    Product
    ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1656-2018·2018-05-16

    Siemens Dimension Vista ALTI Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Drugs)·D-0828-2018·2018-05-16

    Septodont Recalls OraVerse Injection Due to Impurity Test Failure

    Septodont Inc. is recalling OraVerse (Phentolamine Mesylate) Injection due to an out-of-specification result for a degradation product impurity.

    Product
    ORAVERSE — ORAVERSE (PHENTOLAMINE MESYLATE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-1800-2018·2018-05-16

    Siemens Healthcare Recalls EMIT II Plus 6-Acetyl Morphine Reagents

    Siemens Healthcare Diagnostics is recalling EMIT II Plus 6-Acetyl Morphine reagents due to incorrect calibrator levels listed in the calibration steps.

    Product
    Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-1780-2018·2018-05-16

    MHC Medical Recalls EasyTouch Insulin Syringes Due to Labeling Error

    MHC Medical Products LLC is recalling 46,600 EasyTouch insulin syringes because retail shelf cartons may display an incorrect lot number.

    Product
    EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1799-2018·2018-05-16

    Siemens Syva EMIT II Plus 6-Acetylmorphine Recalled for Calibration Error

    Siemens Healthcare Diagnostics is recalling Syva EMIT II Plus 6-Acetylmorphine reagents because the calibrator level listed in the qualitative calibration steps is incorrect.

    Product
    Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
    Category
    Medical Device
    Distribution
    9 states
  • SevereCPSC·18156·2018-05-15

    Regency Gas Stove Fireplaces Recalled for Explosion and Injury Hazards

    Regency is recalling U37 and U39 gas stove fireplaces because the pressure release system can fail, causing explosions and injuries.

    Product
    Regency Ultimate direct vent gas stove fireplaces (models U37 and U39)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V316000·2018-05-15

    Navistar Recalls 2018 IC Bus CE for Emergency Window Defect

    Navistar is recalling 2018 IC Bus CE transit buses because the emergency window release mechanism may be difficult to open, potentially hindering exit during an emergency.

    Product
    IC BUS — IC BUS CE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18157·2018-05-15

    NY Thermal Recalls Residential and Commercial Boilers Due to Carbon Monoxide Hazard

    NY Thermal is recalling approximately 16,000 Trinity Tft and Slant/Fin CHS gas boilers because a deteriorating seal may allow carbon monoxide to leak into homes.

    Product
    NY Thermal (NTI) Trinity Tft and Slant/Fin CHS residential and commercial boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18158·2018-05-15

    Michaels Recalls 3-Tier Haunted Townhouse Candle Holders Due to Fire Risk

    Michaels is recalling 3-Tier Haunted Townhouse candle holders because they can ignite, posing fire and burn hazards. One ignition incident was reported, with no injuries.

    Product
    3-Tier Haunted Townhouse candle holders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·18155·2018-05-14

    Harbor Freight Recalls 14-Inch Electric Chainsaws Due to Serious Injury Hazard

    Harbor Freight Tools is recalling approximately 1,020,000 14-inch electric chainsaws because the power switch can malfunction, allowing the saw to continue operating after being turned off.

    Product
    Portland, One Stop Gardens, and Chicago Electric 14 inch electric chainsaws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V313000·2018-05-14

    Keystone Montana Fifth-Wheel Trailers Recalled for Fire Risk

    Keystone is recalling 2018 Montana fifth-wheel trailers because the slide-out room switch may lack circuit protection, increasing fire risk.

    Product
    KEYSTONE — KEYSTONE MONTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V312000·2018-05-14

    Ford Recalls 2018 Ecosport for Incorrect Brake Fluid Cap Labeling

    Ford is recalling 2018 Ecosport vehicles because they have European brake cap labels and manuals, which may confuse owners and affect brake performance.

    Product
    FORD — FORD ECOSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V314000·2018-05-14

    BMW Recalls 2010-2011 335d Vehicles for Battery Cable Defect

    BMW is recalling 2010-2011 335d vehicles because a battery cable connection may degrade, causing intermittent power loss and unexpected stalling.

    Product
    BMW — BMW 335D
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V310000·2018-05-14

    Trail Boss Recalls One Horse Trailer Due to Propane Leak Risk

    Trail Boss is recalling one 2017 Twister Horse Trailer because a loose or missing propane gas valve screw may allow gas to leak, increasing fire risk.

    Product
    TRAIL BOSS — TRAIL BOSS TWISTER HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V309000·2018-05-13

    MCI Motor Coaches Recalled for Exhaust Pipe Fire Risk

    Motor Coach Industries is recalling 1,123 motor coaches because exhaust bellow pipes may develop holes, allowing hot gases to leak and increase fire risk.

    Product
    MCI — MCI D4000, D4500, D4005, D4505
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V308000·2018-05-11

    Kenworth Recalls 2018 T270 Trucks Due to Front Wheel Hub Defect

    PACCAR is recalling 2018 Kenworth T270 trucks because an incorrectly installed front wheel hub component may cause bearing failure and wheel separation.

    Product
    KENWORTH — KENWORTH T270
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V306000·2018-05-11

    Navistar Recalls 2019 International LT Trucks for Brake Drum Defect

    Navistar is recalling 2019 International LT heavy diesel trucks because lightweight brake drums may overheat, crack, or separate, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V307000·2018-05-11

    Newmar Recalls 2016-2018 Mountain Aire Motorhomes for Tire Damage Risk

    Newmar is recalling 2016-2018 Mountain Aire motorhomes because the DEF tank bracket may contact the tag axle tire, potentially causing tire failure and increasing crash risk.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V304000·2018-05-10

    GM Recalls 2016-2018 Chevrolet Cruze Vehicles for Fuel Leak Risk

    General Motors is recalling 2016-2018 Chevrolet Cruze LS vehicles because they may leak gasoline after a rear-impact crash and rollover, increasing fire risk.

    Product
    CHEVROLET — CHEVROLET CRUZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18152·2018-05-10

    ALDI Recalls Ambiano Mini Deep Fryers Due to Fire and Burn Hazards

    ALDI is recalling Ambiano mini deep fryers because the heating element can overheat, posing fire and burn hazards. Three fire incidents and minor property damage have been reported.

    Product
    Ambiano mini deep fryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18153·2018-05-10

    Munchkin Recalls Waterpede Bath Toys Due to Choking Hazard

    Munchkin is recalling Waterpede bath toys because they can break apart and expose small beads, posing a choking hazard to young children.

    Product
    Waterpede™ children's bath toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18741·2018-05-10

    Tobi Recalls Babynest Crib Bumpers Due to Strangulation Hazard

    Tobi USA LLC is recalling Babynest crib bumpers sold online at babybay.us because the strings pose a strangulation hazard to babies.

    Product
    Babynest crib bumpers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18154·2018-05-10

    illy Recalls 8.8-Ounce Whole Bean Coffee Cans Due to Lid Injury Hazard

    illy is recalling about 65,000 8.8-ounce whole bean coffee cans because the lid can detach suddenly with force upon opening, posing an injury hazard.

    Product
    illy 8.8-ounce whole bean coffee cans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1412-2018·2018-05-09

    Mccall Farms Recalls Canned Spinach Due to Potential Peanut Contamination

    Mccall Farms is recalling Happy Harvest Leaf Spinach cans because they may contain boiled peanuts instead of spinach. The recall affects 739 cases distributed across 16 states.

    Product
    Happy Harvest Leaf Spinach; Net Wt. 13.5 oz (383g); Ingredients: Spinach, Water, Salt. Distributed by Aldi Inc. Batavia, IL 60510; Product of USA; Manufactured In A Facility That Processes Peanuts and Soy. May Contain Peanuts and Soy. Packaged in a steel 2-piece can.
    Category
    Food
    Distribution
    16 states
  • CriticalFDA (Food)·F-1478-2018·2018-05-09

    FDA Recalls Kratom Powder Due to Potential Salmonella Contamination

    Viable Solutions, LLC is recalling Mitragyna Speciosa Leaf Powder (Kratom) because it may be contaminated with Salmonella.

    Product
    Mitragyna Speciosa Leaf Powder-Thai Maeng Da, sold under the brand name Herbal-Salvation.com. The powder is packaged in kraft paper, foil-lined heat sealed pouches and sold in 25g, 100g, 250g, and 1000g. The product label is read in parts: "***herbal-salvation***Mitragyna…
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1177-2018·2018-05-09

    Ignite Pre-Workout Supplement Recalled for Undeclared Milk Allergen

    Independent Nutrition, Inc. is recalling Ignite High Endurance Pre-Workout Supplement because the label declares whey protein but fails to declare milk.

    Product
    Ignite High Endurance Pre-Workout Supplement CAFFEINE FREE Formula, brand Wynant's Familty Health Foods, Net wt. 2.64 lbs. UPC 8 01650 01551 8. SAMPLE ONLY.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1477-2018·2018-05-09

    Viable Solutions Recalls Mitragyna Speciosa Leaf Powder Due to Salmonella Risk

    Viable Solutions, LLC is recalling Mitragyna Speciosa Leaf Powder (Green Horn) sold as Herbal-Salvation.com due to potential Salmonella contamination.

    Product
    Mitragyna Speciosa Leaf Powder-GREEN Horn, sold under the brand name Herbal-Salvation.com. The powder is packaged in kraft paper, foil-lined heat sealed pouches and sold in 25g, 100g, 250g, and 1000g. The product label is read in parts: "***herbal-salvation***Mitragyna…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1329-2018·2018-05-09

    Target Recalls Ben & Jerry's Glampfire Trail Mix Due to Temperature Issues

    Target is recalling 2,652 pints of Ben & Jerry's Glampfire Trail Mix in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Ben & Jerry's Glampfire Trail Mix 1 pint UPC: 76840001194 Target item number: 288-7-21
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0703-2018·2018-05-09

    AuroMedics Recalls Linezolid Injection Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling Linezolid Injection bags due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.

    Product
    LINEZOLID — LINEZOLID (LINEZOLID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1302-2018·2018-05-09

    Target Recalls Halo Top Caramel Macchiato Ice Cream in Hawaii

    Target is recalling Halo Top Caramel Macchiato ice cream sold in Honolulu due to improper temperature control during shipping, which may have allowed contamination.

    Product
    Halo Top Caramel Macchiato UPC: 858089003357 Target item number: 288-7-1669
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1228-2018·2018-05-09

    Target Recalls Breyers Oreo Chips Ahoy Ice Cream in Hawaii

    Target is recalling 2,652 units of Breyers 48oz Oreo Chips Ahoy 2 in 1 ice cream sold in Honolulu, HI, due to improper temperature control during shipping.

    Product
    Breyers 48oz Oreo Chips Ahoy 2 in 1 UPC: 775670008976 Target item number: 288-7-2765
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1367-2018·2018-05-09

    Target Recalls Gardein Crispy Chick N Sliders Due to Temperature Issues

    Target is recalling 2,652 units of Gardein Crispy Chick N Sliders sold in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    GARDEIN 11OZ CRISPY CHICK N SLIDERS UPC: 842234001398 Target item number: 270-3-67
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1406-2018·2018-05-09

    Parade Salsa Recalled for Potential Glass Contamination

    Giovanni Food Company is recalling Parade Salsa Medium due to potential glass contamination. Consumers should stop using the product.

    Product
    Parade Salsa MEDIUM/MEDIANO NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08876 1
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0705-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling 261,250 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1194-2018·2018-05-09

    Target Recalls Enlightened Cookies & Cream Ice Cream Pints in Hawaii

    Target is recalling Enlightened Cookies & Cream ice cream pints sold in Hawaii because a shipping container was not held at the proper temperature, posing a potential contamination risk.

    Product
    Enlightened Cookies & Cream Pint UPC: 852109331130 Target item number 288-7-1796
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1281-2018·2018-05-09

    Target Recalls Halo Top S'mores Ice Cream Due to Temperature Issues

    Target is recalling Halo Top S'mores ice cream sold in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Halo Top S'mores 1 Pint; UPC: 858089003180 Target item number: 288-7-1042
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0709-2018·2018-05-09

    AuroMedics Recalls Levofloxacin IV Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling 308,112 bags of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1175-2018·2018-05-09

    Ignite Pre-Workout Supplement Recalled for Undeclared Milk Allergen

    Independent Nutrition, Inc. is recalling Ignite High Endurance Pre-Workout Supplement Vanilla because the label declared whey protein but failed to declare milk.

    Product
    Ignite High Endurance Pre-Workout Supplement VANILLA, brand Back to Health, Net wt. 1 lb. UPC 8 01650 01540 2 and no UPC Ignite High Endurance Pre-Workout Supplement VANILLA, brand Body-B-Healthy, net wt. 1 lb. UPC 8 01650 01540 2. SAMPLE ONLY. Ignite High Endurance…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1266-2018·2018-05-09

    Target Recalls Breyers Delights Raspberry Chocolate Ice Cream in Hawaii

    Target is recalling Breyers Delights Raspberry Chocolate ice cream in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Breyers Delights Raspberry Chocolate 1pt UPC: 775670011600 Target item number: 288-7-275
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1172-2018·2018-05-09

    Riddhi USA Inc. Recalls All Dietary Supplements Under Consent Decree

    Riddhi USA Inc. is recalling all dietary supplements it manufactures and distributes in New York, Delaware, and New Jersey pursuant to a Consent Decree.

    Product
    All dietary supplements manufactured and distributed by Riddhi USA Inc.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1603-2018·2018-05-09

    Philips MultiDim Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 184 MultiDim Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1605-2018·2018-05-09

    Philips MultiDiagnost Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 37 MultiDiagnost Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1260-2018·2018-05-09

    Target Recalls Popsicle Fruit Pop Mango Due to Temperature Control Issues

    Target is recalling Popsicle Fruit Pop Mango units sold in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Popsicle Fruit Pop Mango 19.8floz - 12ct UPC: 77567001283 Target item number: 288-7-1147
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0706-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling Levetiracetam Injection due to a lack of assurance of sterility and a confirmed report of leaking bags and mold.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2018·2018-05-09

    PerkinElmer Specimen Gate Screening Center Software Recall for Data Errors

    PerkinElmer is recalling Specimen Gate Screening Center software due to potential errors in neonatal screening results, including false negatives and positives.

    Product
    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1174-2018·2018-05-09

    Ignite Pre-Workout Supplement Recalled for Undeclared Milk Allergen

    Independent Nutrition, Inc. is recalling Ignite High Endurance Pre-Workout Supplement because the label declares whey protein but fails to declare milk.

    Product
    Ignite High Endurance Pre-Workout Supplement with Caffeine, brand Back to Health, Net wt. 1 lb. UPC 8 01650 01540 2. Ignite High Endurance Pre-Workout Supplement with CAFFEINE, brand Muscle Sports & Nutrition (MSN), Net wt. 1 lb. UPC 8 01650 01540 2 and UPC 8 01650 01541 9.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1607-2018·2018-05-09

    Philips MD-Eleva Medical Imaging System Recalled for Tilt Actuator Failure

    Philips is recalling 199 MD-Eleva imaging systems because a tilt actuator may break, causing the table to rotate uncontrollably at high speed.

    Product
    Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1193-2018·2018-05-09

    Target Recalls Enlightened Movie Night Pint Due to Temperature Issues

    Target is recalling Enlightened Movie Night Pint products in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Enlightened Movie Night Pint UPC: 852109331109 Target item number 288-7-1798
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1606-2018·2018-05-09

    Philips MD-Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 206 MD-Eleva imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.

    Product
    Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1538-2018·2018-05-09

    Zimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors

    Zimmer Biomet is recalling 18 modular hip head components because two lots of different sizes were potentially commingled. This may lead to the use of an incorrect sized head.

    Product
    Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1343-2018·2018-05-09

    Target Recalls Old Orchard Apple Juice Due to Temperature Control Issues

    Target is recalling 2,652 units of Old Orchard Apple Juice 100% 12oz in Hawaii because a shipping container was not held at the proper temperature, posing a risk of contamination.

    Product
    OLD ORCHARD APPLE JUICE 100% 12OZ UPC: 75355112418 Target item number: 270-14-81
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0804-2018·2018-05-09

    Sanofi Recalls Over-Concentrated Docetaxel Injection Vials Nationwide

    Sanofi-Aventis is recalling 19,580 vials of Docetaxel injection concentrate due to potential over-concentration. The affected lots were distributed nationwide.

    Product
    DOCETAXEL — DOCETAXEL (DOCETAXEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0704-2018·2018-05-09

    AuroMedics Recalls Levofloxacin IV Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1199-2018·2018-05-09

    Target Market Pantry Chicken Tail Off Recall Due to Temperature Issues

    Target is recalling Market Pantry Chicken Tail Off products purchased in Honolulu, Hawaii, because a shipping container was not held at the proper temperature.

    Product
    MARKET PANTR 150-200CT. 16OZ CKD TAIL OFF; UPC: 85239004555 Target item number 210-7-455
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1305-2018·2018-05-09

    Target Recalls Rocky Road Ice Cream Due to Temperature Control Issues

    Target is recalling specific units of MP Ice Cream Rocky Road 48oz purchased in Honolulu, HI, because the shipping container was not held at the proper temperature.

    Product
    MP ICE CREAM ROCKY ROAD 48OZ UPC: 85239734179 Target item number: 288-7-3417
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1210-2018·2018-05-09

    Target Recalls Organic Broccoli Florets Due to Temperature Control Issues

    Target is recalling 2,652 units of Simply Balanced Organic Broccoli Florets sold in Hawaii because a shipping container was not held at the proper temperature.

    Product
    Simply Balanced Organic Broccoli Florets 10oz UPC: 85239008775 Target item number: 270-0-248
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1179-2018·2018-05-09

    Eataly Artichoke Spread Recalled for Undeclared Walnuts

    Eataly NY, LLC is recalling Eataly Artichoke Spread because it contains undeclared walnuts. The product was distributed in New York.

    Product
    eataly artichoke spread, net wt. 7oz 200g, UPC 612067
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0707-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling 67,300 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1222-2018·2018-05-09

    Target Recalls Market Pantry Java Chunk Due to Temperature Issues

    Target is recalling Market Pantry Java Chunk 48oz cans sold in Honolulu because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Market Pantry Java Chunk 48oz UPC: 85239724095 Target item number: 288-7-2409
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1232-2018·2018-05-09

    Target Recalls Canned Corn Due to Temperature Control Issues

    Target is recalling 12-ounce cans of yellow and white corn sold in Hawaii because the shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    MP CORN 12OZ YELLOW WHITE CORN UPC: 85239005231 Target item number: 270-0-523
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1341-2018·2018-05-09

    Target Recalls 12-Ounce Cauliflower Due to Temperature Control Issues

    Target is recalling 12-ounce cauliflower sold in Hawaii because a shipping container was not held at the proper temperature, which could allow contamination.

    Product
    MP CAULIFLWR 12OZ CAULIFLOWER UPC: 85239521007 Target item number: 270-0-521
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1609-2018·2018-05-09

    Philips MultiDiagnostic-Eleva Imaging System Recalled Due to Uncontrolled Table Rotation

    Philips is recalling the MultiDiagnostic-Eleva imaging system because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1258-2018·2018-05-09

    Target Recalls Stouffers Macaroni and Cheese Due to Temperature Issues

    Target is recalling 2,652 units of Stouffers Macaroni and Cheese in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Stouffers Macaroni and Cheese 12oz UPC: 13800103406 Target item number: 270-2-1499
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1263-2018·2018-05-09

    Target Recalls Organic Cut Corn Due to Temperature Control Issues

    Target is recalling Simply Balanced Organic Cut Corn sold in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Simply Balanced Organic Cut Corn 10oz. UPC: 85239008713 Target item number: 270-0-578
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0708-2018·2018-05-09

    AuroMedics Recalls Levofloxacin Injection Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and reports of leaking bags with mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1407-2018·2018-05-09

    Parade Salsa Recalled for Potential Glass Contamination

    Giovanni Food Company is recalling Parade Salsa Mild/Suave 24 oz because the product may contain pieces of glass.

    Product
    Parade Salsa MILD/SUAVE NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08421 3
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1585-2018·2018-05-09

    Hitachi MHI-TM2000 Linear Accelerator Recalled for Software Anomaly

    Hitachi is recalling one MHI-TM2000 Linear Accelerator System in New York due to a software anomaly that may prevent patient positioning correction, potentially irradiating the wrong body part.

    Product
    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1176-2018·2018-05-09

    Ignite Pre-Workout Supplement Recalled for Undeclared Milk Allergen

    Independent Nutrition, Inc. is recalling Ignite High Endurance Pre-Workout Supplement because the label declared whey protein but failed to declare milk.

    Product
    Ignite High Endurance Pre-Workout Supplement, brand Back to Health, Net wt. 1 lb. UPC 8 01650 01541 9. Ignite High Endurance Pre-Workout Supplement, brand Healthy Home Center Inc., Net wt. 1 lb. UPC 8 01650 01541 9. Ignite High Endurance Pre-Workout Supplement, brand…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1411-2018·2018-05-09

    Cal Maine Foods Recalls Shelled Eggs Due to Salmonella Risk

    Cal Maine Foods is recalling shelled eggs sold as Publix and Sunups brands because they may contain Salmonella. The product was distributed in Florida and Georgia.

    Product
    Shelled Eggs, Extra Large 18pk sold under the brand names of Publix UPC 0 41415 00966 0 & Sunups UPC 0 28621 36398 4
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1608-2018·2018-05-09

    Philips MultiDiagnostic-Eleva Recalled Due to Uncontrolled Table Rotation Hazard

    Philips Medical Systems is recalling 184 MultiDiagnostic-Eleva systems because a broken actuator fixation can cause the table to rotate uncontrollably at high speed.

    Product
    MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1604-2018·2018-05-09

    Philips URODiagnost Imaging System Recalled Due to Uncontrolled Table Rotation

    Philips Medical Systems is recalling 20 URODiagnost imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.

    Product
    708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1361-2018·2018-05-09

    Target Recalls Gardein Beefless Ground Due to Temperature Control Failure

    Target is recalling 2,652 units of Gardein Ultimate Beefless Ground in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Gardein Ultimate Beefless Ground 13.8oz UPC: 842234000988 Target item number: 270-3-9
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1601-2018·2018-05-09

    Southwest Technologies Recalls Hypothermia Mitts, Slippers, and Caps for Misbranding

    Southwest Technologies Inc. is recalling hypothermia mitts, slippers, and caps because they are misbranded for chemotherapy use and linked to two frostbite events.

    Product
    HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1356-2018·2018-05-09

    Target Recalls CW Ultimate Southwest Veg Due to Temperature Control Failure

    Target is recalling CW Ultimate Southwest Veg 14oz cans in Hawaii because a shipping container was not held at the proper temperature, posing a risk of contamination.

    Product
    CW ULTIMATE SOUTHWEST VEG 14OZ UPC: 70332002881 Target item number: 270-0-4
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1265-2018·2018-05-09

    Target Recalls MP Fruit Cans Due to Temperature Control Failure

    Target is recalling MP Fruit 48oz cans in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    MP FRUIT 48OZ MEDIUM TRIPLE BRY UPC: 85239270219 Target item number: 270-14-201
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1476-2018·2018-05-09

    FDA Recalls Mitragyna Speciosa Leaf Powder Due to Salmonella Contamination Risk

    Viable Solutions, LLC is recalling Mitragyna Speciosa Leaf Powder products because they may be contaminated with Salmonella.

    Product
    Mitragyna Speciosa Leaf Powder Red Vein Sumatra and Mitragyna Speciosa Leaf Powder Red Vein Bali, sold under the brand name Herbal-Salvation.com. The powder is packaged in kraft paper, foil-lined heat sealed pouches and sold in 25g, 100g, 250g, and 1000g. The product label…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1351-2018·2018-05-09

    Target Recalls Halo Top Caramel Macchiato Ice Cream in Hawaii

    Target is recalling Halo Top Caramel Macchiato Non Dairy Pints in Hawaii because a shipping container was not held at the proper temperature, posing a risk of contamination.

    Product
    Halo Top Caramel Macchiato Non Dairy Pint UPC: 858089003432 Target item number: 288-7-1674
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1602-2018·2018-05-09

    Southwest Technologies Recalls Hypothermia Slippers Due to Misbranding and Frostbite Reports

    Southwest Technologies is recalling hypothermia slippers because they are misbranded for chemotherapy use and two frostbite events were reported.

    Product
    HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1204-2018·2018-05-09

    Target Recalls Market Pantry Cooked Shrimp Due to Temperature Control Issues

    Target is recalling Market Pantry Tail-On Cooked Shrimp sold in Hawaii because the shipping container was not held at the proper temperature, posing a risk of contamination.

    Product
    Tail-On Cooked Shrimp - 16oz - Market Pantry UPC: 85239031353 Target item number: 210-7-264
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1451-2018·2018-05-09

    Siemens SOMATOM Spirit CT Scanner Recalled for Incorrect Dose Calculations

    Siemens Medical Solutions is recalling SOMATOM Spirit CT scanners because the CARE Dose4D algorithm may calculate incorrect tube current for head scans, potentially leading to unnecessary radiation exposure.

    Product
    SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1592-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Exhaust Lines Due to Sterility Concerns

    Cook Inc. is recalling 760 StoneBreaker Exhaust Lines because the interior may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
    Category
    Medical Device
    Distribution
    Distributed nationwide

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