The Recall Desk

Archive

March 2016 recalls

772 recalls were announced in March 2016.

What the numbers show

Critical
29
Severe
169
High
353
Moderate
197
Low
24

Of the 772 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

1–100 of 772

  • SevereNHTSA·16V183000·2016-03-31

    Ford Recalls 2015-2016 Lincoln MKC and Explorer for Fire Risk

    Ford is recalling 2015-2016 Lincoln MKC and 2016 Ford Explorer vehicles because engine block heaters may overheat and cause a fire.

    Product
    LINCOLN — LINCOLN, FORD MKC, EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16134·2016-03-31

    Gamewell-FCI Recalls Fire Alarm Panels Due to Failure to Alert

    Gamewell-FCI is recalling approximately 1,000 fire alarm panels because specific configurations may cause the system to fail to detect and respond to fire, smoke, or carbon monoxide alarms.

    Product
    Gamewell-FCI fire alarm panels (ILI-MB-E3 and ILI-S-E3)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16735·2016-03-31

    Grosfillex Recalls Havana Commercial Side Chairs and Bar Stools

    Grosfillex is recalling Havana commercial side chairs and armless bar stools because the backrest can crack and detach, posing a fall hazard.

    Product
    Havana side chairs and armless bar stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16129·2016-03-31

    Manhattan Toy Recalls Busy Loops Table Top Toys Due to Choking Hazard

    The Manhattan Toy Company is recalling Busy Loops table top toys because plastic beads can break off, posing a choking hazard. No injuries have been reported.

    Product
    Busy Loops table top toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16E024000·2016-03-31

    Strategic Sports Recalls Leather Up XElement Motorcycle Helmets

    Strategic Sports is recalling specific Leather Up XElement motorcycle helmets that may not adequately protect users in a crash, failing federal safety standards.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16133·2016-03-31

    CE North America Recalls KUL Fan Heaters Due to Fire Hazard

    CE North America is expanding a recall of KUL fan heaters sold at H-E-B in Texas due to a fire hazard. One overheating incident was reported, with no injuries or property damage.

    Product
    KUL fan heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0782-2016·2016-03-30

    Southeastern Grocers Recalls Bi-Lo Fruit Trays for Listeria

    Southeastern Grocers is recalling Bi-Lo fruit trays containing cantaloupe, grapes, and strawberries because a sample tested positive for Listeria species.

    Product
    Bi-Lo, Walters Fruit Tray Cantaloupe (Cantaloupe, Grapes and Strawberries), various net wt., in clear plastic trays.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0780-2016·2016-03-30

    Southeastern Grocers Recalls Bi-Lo Mixed Melon Chunks Due to Listeria

    Southeastern Grocers is recalling Bi-Lo Mixed Melon Chunks in Georgia because a product sample tested positive for Listeria species.

    Product
    Bi-Lo, Mixed Melon Chunks (in Medium, and Large containers), containing Cantaloupe, Honeydew and Watermelon, various net wt. in clear plastic containers.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0780-2016·2016-03-30

    Sagent Recalls Fluconazole Injection Due to Cross-Contamination with Metronidazole

    Sagent Pharmaceuticals is recalling specific lots of Fluconazole Injection due to cross-contamination with metronidazole. The affected product is distributed nationwide and in Puerto Rico.

    Product
    Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0779-2016·2016-03-30

    Southeastern Grocers Recalls Bi-Lo Fresh Cantaloupe Due to Listeria

    Southeastern Grocers is recalling Bi-Lo Fresh Cantaloupe products in Georgia because a sample tested positive for Listeria species.

    Product
    Bi-Lo, Fresh Cantaloupe, Chunks Medium Container, Chunks Large Container, Halves and Slices, various net wt., in clear plastic containers.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F0778-2016·2016-03-30

    NP Nutra Recalls Organic Spinach Powder Due to Salmonella Risk

    NP Nutra is recalling organic spinach powder due to potential Salmonella contamination. The product was distributed across multiple U.S. states and foreign countries.

    Product
    NP Nutra Spinach Powder Organic SKU: 790 Net Weight: 22.72kg Gross Weight: 24kg Product of USA
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1220-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    The FDA is recalling specific lots of Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.

    Product
    Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1242-2016·2016-03-30

    Siemens IMMULITE 1000 Estradiol Test Recalled for Faslodex Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol Test kits because the drug Faslodex may cause falsely elevated results.

    Product
    IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0790-2016·2016-03-30

    Nestle Recalls Lean Cuisine Spinach Artichoke Ravioli Due to Glass Contamination

    Nestle is recalling Lean Cuisine Spinach Artichoke Ravioli due to the potential presence of glass pieces. Consumers should stop eating the product and return it to the store.

    Product
    Lean Cuisine Marketplace Spinach Artichoke Ravioli, UPC 13800-55806, Keep Frozen. Net Wt. 9 oz (255g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0781-2016·2016-03-30

    Bi-Lo Mixed Fruit Bowl Recalled for Listeria Contamination

    Southeastern Grocers is recalling Bi-Lo Mixed Fruit Bowls because a product sample tested positive for Listeria species.

    Product
    Bi-Lo, Mixed Fruit Bowl (in Medium, and Large containers), containing Strawberries, Grapes, Honeydew, Cantaloupe, Pineapple, Watermelon, Blueberries, Blackberries, Raspberries and Kiwi, various net wt., in clear plastic containers.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0803-2016·2016-03-30

    Recall of Big Bob Gibson Seasoning Due to Glass Shards

    Ingredients Corporation of America is recalling Big Bob Gibson B-B-Q Seasoning because glass shards were found in a sealed bag of dehydrated minced garlic used in the product.

    Product
    BIG BOB GIBSON B-B-Q Seasoning and dry rub, 6.35 oz, 180.0225 g., Distributed by Mrs. Stratton's Salads, Inc., Birmingham, AL, UPC 8366577777
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·16V179000·2016-03-30

    Forest River Recalls Puma Trailers Due to Tire Clearance Defect

    Forest River is recalling 2008-2016 Puma recreational trailers and toy haulers because tires may contact the wheel well, risking deflation and loss of control.

    Product
    FOREST RIVER — FOREST RIVER PUMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1219-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Covidien LLC is recalling Castile soap towelettes found in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0777-2016·2016-03-30

    D.S. Waugh Recalls Chappaqua Crunch Granola Due to Salmonella Contamination

    D.S. Waugh is recalling Chappaqua Crunch Simply Granola with Blueberries & Bananas because it may be contaminated with Salmonella.

    Product
    Chappaqua Crunch Simply Granola with Blueberries & Bananas, in 13 ounce clear plastic pouch. UPC:7 86516 16007 9
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1221-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling specific lots of Castile soap towelettes used in medical kits because they are contaminated with bacteria.

    Product
    Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2016·2016-03-30

    Intuitive Surgical Recalls da Vinci Surgeon Side Console Touchpads

    Intuitive Surgical is recalling 542 da Vinci Si and Xi Surgeon Side Console touchpads due to a Class II defect. The recall covers units distributed in the US and 33 other countries.

    Product
    da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary a
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1205-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0801-2016·2016-03-30

    C & J Butcher Shop BBQ Sauce Recalled for Glass Shards

    Ingredients Corporation of America is recalling C & J Butcher Shop Recipe #10 BBQ Sauce because glass shards were found in a sealed bag of dehydrated minced garlic used in the product.

    Product
    C & J BUTCHER SHOP, Recipe #10 BBQ Sauce, Net Wt. 763 oz. and 18.5oz., developed by & Available only from C&J Butcher Shop, Granbury, TN 76048
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1192-2016·2016-03-30

    QiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues

    QiG Group LLC is recalling 40 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close.

    Product
    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1201-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes in Foley trays and midstream kits due to bacterial contamination.

    Product
    Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2016·2016-03-30

    Siemens Dimension Vista Estradiol Test Recalled Due to Interference

    Siemens is recalling Dimension Vista Estradiol tests because the drug fulvestrant may cause falsely elevated results.

    Product
    Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2016·2016-03-30

    Algovita External Pulse Generator Recalled for Connection Issues

    QiG Group LLC is recalling 31 Algovita External Pulse Generators because they may fail to connect to external devices, preventing reprogramming and recharging.

    Product
    Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0792-2016·2016-03-30

    Nestle Recalls Stouffer's Vegetable Lasagna Due to Potential Glass Contamination

    Nestle USA is recalling Stouffer's vegetable lasagna products due to the potential presence of glass pieces. Consumers should check their freezers for affected items.

    Product
    Stouffer's vegetable lasagna. Keep Frozen. Sold in the following sizes and UPC: 1. Party Size Net Wt. 96 oz (6 lb) 2.72kg UPC 13800-19002. 2. Net Wt. 10 1/2 oz (297g) UPC 13800-10323. 3. Family Size Net Wt. 37 1/2 oz (2 lbs. 5 1/2 oz) 1.06 kg, UPC 13800-55510. 4. Food
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V180000·2016-03-30

    Starcraft RV Recalls 2016 Launch Ultra Lite Trailers Due to Step Defect

    Starcraft RV is recalling 26 model year 2016 Launch Ultra Lite trailers because entry steps may have been installed with improper bolts, posing a fall risk.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT LAUNCH ULTRA LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Castile soap towelettes used in Foley trays and specimen kits are recalled because they are contaminated with bacteria.

    Product
    Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16131·2016-03-30

    Toshiba Recalls Laptop Battery Packs Due to Burn and Fire Hazards

    Toshiba is recalling Panasonic lithium-ion battery packs for specific laptops due to overheating risks that can cause burns and fires. No injuries have been reported.

    Product
    Panasonic battery packs used in Toshiba laptop computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2016·2016-03-30

    Anspach Effort Recalls Irrigation Clip 30 Due to Incorrect Assembly

    The Anspach Effort, Inc. is recalling Irrigation Clip 30 units assembled with incorrect smaller front clips. The affected clips were distributed in Pennsylvania, Minnesota, and Switzerland.

    Product
    Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1210-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    The FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2016·2016-03-30

    Castile Soap Towelettes in Medical Kits Recalled for Bacterial Contamination

    The FDA is recalling Castile soap towelettes included in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    The FDA is recalling Castile soap towelettes included in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0799-2016·2016-03-30

    ICA Gourmet Seasonings Recalled Due to Glass Shards in Garlic

    Ingredients Corporation of America is recalling ICA Gourmet Seasonings because glass shards were found in dehydrated minced garlic used in the product.

    Product
    ICA GOURMET SEASONINGS, SIDE CAR HOUSE BLEND LESS SALT, 02-3992R4, NET WEIGHT 25 POUNDS, INGREDIENTS CORP. OF AMERICA, INC.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1202-2016·2016-03-30

    Recall of Contaminated Castile Soap Towelettes in Medical Kits

    FDA is recalling specific lots of Castile soap towelettes used in medical kits due to bacterial contamination.

    Product
    Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0783-2016·2016-03-30

    Parade Salted Peanuts Recalled for Undeclared Wheat

    Star Snacks Co. is recalling Parade Salted Peanuts Dry Roasted, 8 oz cans, due to undeclared wheat.

    Product
    Parade Salted Peanuts Dry Roasted, Net Wt. 8 oz Distributed by Federated Group, Inc. 3025 W. Salt Creek Ln Arlington Heights, IL 60005 UPC 050700569376
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1193-2016·2016-03-30

    QiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues

    QiG Group LLC is recalling 34 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close, preventing reprogramming and recharging.

    Product
    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0802-2016·2016-03-30

    ICA Gourmet Seasonings Sesame Garlic Dip Recalled for Glass Shards

    Ingredients Corporation of America is recalling Sesame Garlic Dip because glass shards were found in a sealed bag of dehydrated minced garlic used in the product.

    Product
    ICA GOURMET SEASONINGS, SESAME GARLIC DIP, 02-4772R1, NET WEIGHT 25 POUNDS, INGREDIENTS CORP. OF AMERICA, INC.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1203-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    FDA is recalling 10,000 units of Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.

    Product
    Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16130·2016-03-30

    Black Diamond Recalls Climbing Carabiners Due to Fall Hazard

    Black Diamond is recalling 1.16 million climbing carabiners because they may unexpectedly open, posing a risk of injury or death from a fall.

    Product
    Black Diamond Carabiners for Climbing
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0794-2016·2016-03-30

    ConAgra Recalls Watts Bros Super Sweet Cut Corn Due to Listeria Risk

    ConAgra Foods is recalling one lot of Watts Bros Super Sweet Cut Corn due to potential Listeria monocytogenes contamination.

    Product
    Label reads in part "***Watts Brothers FARMS SUPERSWEET CUT CORN***NET WT 20 LB*** Distributed by ConAgra Foods Kennewick, WA 99336 PRODUCT OF U.S.A.***" Product is blanched then frozen and placed in a plastic lined cardboard box. UPC 1 06 81241 05167 8
    Category
    Food
    Distribution
    4 states
  • HighCPSC·16132·2016-03-30

    Black Diamond Recalls Nylon Runners Due to Fall Hazard

    Black Diamond is recalling nylon runners with tape splices that may fail during use, posing a risk of death or injury from a fall.

    Product
    Nylon Runners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling 118,400 kits of Castile soap towelettes due to bacterial contamination. The products are used to clean the genital area.

    Product
    Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2016·2016-03-30

    Castile Soap Towelettes Recalled for Bacterial Contamination

    FDA is recalling Aplicare Castile Soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.

    Product
    Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    Covidien LLC is recalling Castile soap towelettes found in Foley trays and midstream specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.

    Product
    Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2016·2016-03-30

    Arthrex Recalls IBalance TKA Tibial Trays Due to Surface Texture Defect

    Arthrex, Inc. is recalling 2,378 IBalance TKA Tibial Trays because the outer metal surface is smooth instead of textured. The devices were distributed nationwide.

    Product
    Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for imp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0788-2016·2016-03-30

    Nestle Recalls Lean Cuisine Pizza for Potential Glass Contamination

    Nestle is recalling Lean Cuisine Craveables Deep Dish Spinach & Mushroom pizza due to the potential presence of glass pieces.

    Product
    Lean Cuisine Craveables Deep Dish Spinach & Mushroom pizza, UPC 13800-13520, Keep Frozen. Net Wt. 6-1/8 oz (173g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Covidien LLC is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2016·2016-03-30

    Aplicare Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.

    Product
    Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes used in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Aplicare Castile Soap towelettes found in Foley trays and specimen kits are being recalled because they are contaminated with bacteria.

    Product
    Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0776-2016·2016-03-30

    Lipari Foods Recalls Dark Chocolate Coffee Beans for Undeclared Almonds

    Lipari Foods is recalling dark chocolate covered coffee beans due to an undeclared tree nut allergen (almonds). The product was distributed in eight states.

    Product
    Dark Chocolate Covered Coffee Beans, packaged in 12 oz. tubs
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0784-2016·2016-03-30

    Northwest Specialty Recalls Dried Lactose Powder for Undeclared Milk Allergen

    Northwest Specialty, Inc. is recalling dried lactose powder sold as Wine-King Beer-King because the label fails to declare whey or milk.

    Product
    Dried lactose powder, product sold under brand Wine-King Beer-King, packaged in three consumer-sized plastic bags of 4 oz., 1 Lb. and 5 Lb. net weight.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1224-2016·2016-03-30

    Castile Soap Towelettes in Medical Kits Recalled for Bacterial Contamination

    FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0798-2016·2016-03-30

    ICA Gourmet Seasonings Recalled Due to Glass Shards in Garlic

    Ingredients Corporation of America is recalling ICA Gourmet Seasonings because glass shards were found in dehydrated minced garlic used in the product.

    Product
    ICA GOURMET SEASONINGS, No Salt Added, nsa SEASONING, House Seasoning, NET W. 20 oz (1 LB. 4 OZ.) 567g, Packed by Ingredients Inc., Memphis, TN
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0775-2016·2016-03-30

    HEB Caramel Pecan Turtle Ice Cream Recalled for Wood Pieces

    HEB Retail Support Center is recalling Caramel Pecan Turtle Ice Cream due to the presence of wood pieces in the product.

    Product
    HEB Creamy Creations Caramel Pecan Turtle Ice Cream Half Gallon/Cont. Net. 1.89 L packaged in cardboard container
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0800-2016·2016-03-30

    KD's Good Stuff Seasoning Recalled for Glass Shards in Garlic

    Ingredients Corporation of America is recalling KD's Good Stuff Seasoning because glass shards were found in a sealed bag of dehydrated minced garlic used in the product.

    Product
    KD's GOOD STUFF SEASONING, NET WT. 5#, KD's, 5395 McKinstry, Moscow, TN, 38057
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0791-2016·2016-03-30

    Nestle Recalls Lean Cuisine Ravioli Due to Potential Glass Contamination

    Nestle is recalling Lean Cuisine Marketplace Ricotta Cheese & Spinach Ravioli due to the potential presence of glass pieces.

    Product
    Lean Cuisine Marketplace Ricotta Cheese & Spinach Ravioli, UPC 13800-93052, Keep Frozen. Net Wt. 8 oz (226g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Castile soap towelettes in Foley trays and specimen kits are recalled because they are contaminated with bacteria.

    Product
    Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2016·2016-03-30

    Qiagen QFT TB Antigen Tubes Recalled for Potential Endotoxin Contamination

    Qiagen is recalling QFT TB Antigen Tubes due to potential endotoxin presence that could cause false positive results in tuberculosis tests.

    Product
    QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0793-2016·2016-03-30

    Nestle Recalls Stouffer's Spinach Souffle Due to Potential Glass Contamination

    Nestle is recalling Stouffer's spinach souffle products due to the potential presence of glass pieces. Consumers should check their freezers for the specific production codes listed.

    Product
    Stouffer's spinach souffle. Simple Dishes. Keep Frozen. Net Wt. 12 oz (340 g) UPC 13800-10585.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0789-2016·2016-03-30

    Nestle Recalls Lean Cuisine Ravioli Due to Potential Glass Pieces

    Nestle is recalling Lean Cuisine Mushroom Mezzaluna Ravioli due to the potential presence of glass pieces. Consumers should stop eating the product.

    Product
    Lean Cuisine Marketplace Mushroom Mezzaluna Ravioli, UPC 13800-58358, Keep Frozen. Net Wt. 8-5/8 oz (244g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2016·2016-03-30

    Nidek RT-5100 and RT-3100 Refractors Recalled for Arm Malfunction

    Nidek Inc is recalling RT-5100 and RT-3100 refractors because the Near Point Chart Arm may lower spontaneously, posing a risk of slight injury to the patient's face or nose.

    Product
    RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0804-2016·2016-03-30

    King Soopers Recalls Apple Strudel for Undeclared Pecans

    King Soopers is recalling Apple Strudel 5 Count packages because the ingredient label fails to declare pecans.

    Product
    Bakery Fresh Goodness Apple Strudel 5 count, 24oz, packaged in Plastic container, distributed by King Soopers Bakery, Denver, CO.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0787-2016·2016-03-30

    Nestle Recalls DiGiorno, Lean Cuisine, and Stouffer's Products Due to Glass

    Nestle is recalling specific DiGiorno, Lean Cuisine, and Stouffer's products because they may contain glass pieces.

    Product
    DiGiorno pizzeria thin crust spinach & mushroom pizza, UPC 71921-58570, Keep Frozen. Net Wt. 18 oz (1 lb 2 oz) 511g
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    The FDA is recalling Aplicare Castile Soap towelettes included in Foley trays and midstream specimen kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2016·2016-03-30

    Ambu Aura Gain Laryngeal Masks Recalled for Sterility Assurance Failure

    Ambu Inc. is recalling Aura Gain laryngeal masks because damage to the sterile barrier may compromise sterility, risking patient contamination.

    Product
    Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1218-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Foley Catheter Trays

    FDA is recalling 300 units of Foley catheter trays containing bacteria-contaminated Castile soap towelettes. The product was distributed in the US and Canada.

    Product
    Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD¿ TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD TRAY COMPONENTS INCLUDING HAND SANITIZER AND SKIN BARR Item Code: P4P18XC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2016·2016-03-30

    Roche cobas p 512 Pre-analytical System Recalled for Sample Spillage

    Roche is recalling 35 cobas p 512 pre-analytical systems because a sensor defect causes open sample tubes to drop and spill.

    Product
    cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1175-2016·2016-03-30

    Toshiba DRAD-3000E Wireless System Recalled for Image Transmission Failure

    Toshiba is recalling 28 DRAD-3000E FPD Wireless Systems because they fail to complete image transmission, resulting in no radiographic image.

    Product
    Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0781-2016·2016-03-30

    AstraZeneca Recalls Tudorza Pressair Inhalers Due to Defective Delivery System

    AstraZeneca is recalling Tudorza Pressair inhalers because some units have actuation counters set to a number other than 60.

    Product
    Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spa
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0774-2016·2016-03-30

    King Henry's Recalls Fruit and Nut Medley for Undeclared Dye

    King Henry's, Inc. is recalling Fruit & Nut Medley because it may contain undeclared FD&C Yellow #6. The recall covers 3,242 units distributed across 25 US states and British Columbia.

    Product
    Fruit & Nut Medley, Snacks Fit for a King, King Size, 12 per case. NP- UPC 61054645419 and 61054645119.
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0806-2016·2016-03-30

    Fabi-Saa Mote Blanco Recalled for Undeclared Sulfites

    FABI - SAA Inc. is recalling Fabi-Saa Mote Blanco due to undeclared sulfites. The product was distributed in New York and New Jersey.

    Product
    Fabi-Saa Mote Blanco Net Wt. 14 oz. (397 g) Imported and Distributed by Fabi-Saa Inc. Belleville, NJ 07109 UPC 874093000090 Made in USA
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1190-2016·2016-03-30

    Zimmer Biomet Issues Correction Notice for Instinct Java System Cleaning Instructions

    Zimmer Biomet is issuing a correction notice to provide updated cleaning and disinfecting instructions for the Instinct Java System and Universal Clamp System.

    Product
    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0779-2016·2016-03-30

    AGA Gas Recalls Bulk Liquid Oxygen Due to GMP Deviations

    AGA Gas Inc is recalling 1,500 gallons of bulk liquid oxygen because the delivery trailer may not have met GMP requirements prior to filling.

    Product
    Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1189-2016·2016-03-30

    Zimmer Spine Universal Clamp System Recall for Updated Cleaning Instructions

    Zimmer Spine is issuing a correction notice for the Universal Clamp System to provide updated cleaning and disinfecting instructions.

    Product
    Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1243-2016·2016-03-30

    Siemens IMMULITE 2000 Estradiol Test Recalled Due to Faslodex Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol Test kits because the drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.

    Product
    IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0773-2016·2016-03-30

    ShopRite Unsalted Dry Roasted Cashews Recalled for Mislabeling

    Wakefern Foods Corp. is recalling ShopRite Unsalted Dry Roasted Cashews because the product may be mislabeled.

    Product
    ShopRite Dry Roasted Unsalted Cashews 7 oz. (198 g) Distributed by Wakefern Food Corp., Elizabeth, NJ 07207 UPC 4119001620
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1244-2016·2016-03-30

    MHI-TM2000 Linear Accelerator Software Recall for Treatment Status Error

    Mitsubishi Heavy Industries is recalling MHI-TM2000 Linear Accelerator Systems due to a software anomaly that may incorrectly change a patient's treatment status to 'Untreated'.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1239-2016·2016-03-30

    CareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error

    CareFusion is recalling 170 Alaris PC Unit Infusion Pump Model 8000 devices because a power supply component may cause system error codes.

    Product
    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
    Category
    Medical Device
    Distribution
    Distributed nationwide

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