The Recall Desk

Archive

April 2016 recalls

764 recalls were announced in April 2016.

What the numbers show

Critical
20
Severe
108
High
373
Moderate
207
Low
56

Of the 764 recalls this month scored against our rubric, 3% are Critical, 14% are Severe.

101–200 of 764

  • ModerateFDA (Food)·F-1116-2016·2016-04-27

    Materne Recalls GoGo squeeZ Applesauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ applesauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Peach/SweetPotato (Pedal Pedal Peach) Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1111-2016·2016-04-27

    Materne Recalls GoGo squeeZ Apple Sauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ apple sauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, 6 x 12, Apple/Mango Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1115-2016·2016-04-27

    Materne Recalls GoGo squeeZ Apple Sauce Pouches Due to Residue

    Materne North America Corp is voluntarily recalling specific GoGo squeeZ apple sauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Pear/Carrot (Zippin'Zingin'Pear) Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1119-2016·2016-04-27

    Materne Recalls GoGo squeeZ Applesauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ applesauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Yellow Carrot/Banana (Boatin' Banana) Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1107-2016·2016-04-27

    Materne Recalls GoGo squeeZ Apple Sauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ apple sauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, 6 x12, 1x18, 4 x16, Apple/Cinnamon Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1110-2016·2016-04-27

    Materne Recalls GoGo squeeZ Apple Sauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ applesauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, 6 x 12, Apple/Grape Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1118-2016·2016-04-27

    Materne Recalls GoGo squeeZ Apple Sauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ apple sauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Grape/Sweet Potato (Grateful Grape) Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1113-2016·2016-04-27

    Materne Recalls GoGo squeeZ Apple Sauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ apple sauce pouches due to potential adulteration from food product residue.

    Product
    Gogo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Strawberry Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0704-2016·2016-04-27

    Halperns' Recalls Sebastian Super Lump Crab Meat Due to Temperature Abuse

    Halperns' Steak & Seafood Company LLC is recalling 47 cans of Sebastian Super Lump Pasteurized Crab Meat in Texas due to product time/temperature abuse.

    Product
    Sebastian Super Lump Pasteurized Crab Meat, Blue Swimming Crab Meat, Wild Caught, 16 ounce
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1523-2016·2016-04-27

    Biocare Medical Recalls Mislabeled Mach 4 Mouse Probe Vials

    Biocare Medical is recalling a single lot of Mach 4 Mouse Probe vials that may be mislabeled as HRP-Polymer.

    Product
    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1501-2016·2016-04-27

    Medtronic Recalls CareLink iPro2 Reports Due to Time Zone Error

    Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because they used the wrong time zone, causing inaccurate timestamps for continuous glucose data.

    Product
    CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0830-2016·2016-04-27

    Hospira Recalls Aminosyn-PF Amino Acid Bags Due to Chemical Contamination

    Hospira Inc. is recalling 1,776 bags of Aminosyn-PF (amino acids) 7% due to potential contamination with an aromatic hydrocarbon resin.

    Product
    Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1112-2016·2016-04-27

    Materne Recalls GoGo squeeZ Applesauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ applesauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Pineapple Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1106-2016·2016-04-27

    Materne Recalls GoGo squeeZ Apple Sauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ apple sauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, Apple/Peach Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1120-2016·2016-04-27

    Materne Recalls GoGo squeeZ Apple Sauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ apple sauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 4 x 16, 120 x 12, 180 x 4, 360 x 4, 6 x 12, 7/16, 1 x 20, 1 x 24, and 36 x 4; Variety Packs/Multi-Packs with Multiple Flavor Varieties
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1503-2016·2016-04-27

    Ad-Tech Recalls Sterile Electrode Cables Due to Package Failures

    Ad-Tech is recalling 197 unopened sterile electrode connection cables because package failures compromised the sterile barriers.

    Product
    Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); 3. L-DCL-8DINX (8 contacts: 1 terminal bl
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1108-2016·2016-04-27

    Materne Recalls GoGo squeeZ Apple Sauce Pouches Due to Residue

    Materne North America Corp. is voluntarily recalling specific GoGo squeeZ apple sauce pouches due to potential adulteration from food product residue.

    Product
    GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, 6 x12, Apple/Banana Flavor Variety
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0824-2016·2016-04-27

    Telmisartan Tablets Recalled Due to Presence of Silicone Foreign Matter

    Torrent Pharmaceuticals is recalling Telmisartan 80 mg tablets because a product complaint identified silicone foreign matter within the tablets.

    Product
    Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1509-2016·2016-04-27

    OraSure Recalls OraQuick HCV Visual Reference Panel Due to Incorrect Insert

    OraSure Technologies is recalling 244 OraQuick HCV Visual Reference Panel kits because the package insert may be incorrect, potentially containing instructions for a different test.

    Product
    OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V241000·2016-04-26

    Toyne Recalls 2014-2015 Pumper Trucks Due to Gearbox Shift Defect

    Toyne Inc. is recalling 2014-2015 Pumper emergency vehicles because a gearbox defect may cause the truck to shift into neutral while driving, increasing crash risk.

    Product
    TOYNE — TOYNE PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V242000·2016-04-26

    Nissan Recalls 2013-2016 Sentra for Front Passenger Air Bag Defect

    Nissan is recalling 2013-2016 Sentra vehicles because a deformed seat belt bracket may prevent the front passenger air bag from turning off when a child seat is installed.

    Product
    NISSAN — NISSAN SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V246000·2016-04-26

    Ford Recalls 2016 F-Series Trucks for Tire Sidewall Damage

    Ford is recalling 2,288 model year 2016 F-250, F-350, F-450, and F-550 trucks because tires may have inner sidewall damage that could cause a blowout.

    Product
    FORD — FORD F-350 SD, F-550 SD, F-450 SD, F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V245000·2016-04-26

    Ford Recalls 2014-2015 Explorers for Rear Suspension Defect

    Ford is recalling 2014-2015 Explorers because rear suspension toe links may fracture, potentially causing loss of steering control and increasing crash risk.

    Product
    FORD — FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V244000·2016-04-26

    Nissan and Infiniti Recall Vehicles Due to Passenger Air Bag Defect

    Nissan is recalling specific 2013-2017 Nissan, Infiniti, and Chevrolet vehicles because the passenger air bag may fail to deploy in a crash.

    Product
    NISSAN — NISSAN, INFINITI, CHEVROLET MURANO HYBRID, QX60 HYBRID, Q50 HYBRID, PATHFINDER HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V247000·2016-04-26

    Ford Recalls Taurus, Flex, and MKS for Air Bag Defect

    Ford is recalling specific 2008-2012 Taurus, Flex, Taurus X, Sable, and MKS vehicles because the driver's frontal air bag may inflate improperly during a crash.

    Product
    FORD — FORD, LINCOLN, MERCURY TAURUS X, FLEX, MKS, TAURUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·027-2016 EXP·2016-04-26

    Pilgrim's Pride Recalls Chicken Products Due to Foreign Matter Contamination

    Pilgrim's Pride is recalling approximately 4.57 million pounds of fully cooked chicken products that may contain plastic, wood, rubber, or metal.

    Product
    Pilgrim's Pride Corporation — Pilgrim's Pride Corp. Recalls Poultry Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·16153·2016-04-26

    Stile Products Recalls Tern Folding Bicycles Due to Frame Hinge Crack Hazard

    Stile Products is expanding a recall of specific Tern folding bicycles because the frame hinge can crack, posing a fall hazard. Consumers should stop riding these bikes and contact the company for a free frame replacement.

    Product
    Tern folding bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16151·2016-04-26

    Ryobi Brushless Snow Blowers Recalled for Fire and Burn Hazards

    One World Technologies is recalling Ryobi 40-Volt Brushless Snow Blowers sold at Home Depot due to overheating risks that can cause fires and burns.

    Product
    Ryobi Brushless Snow Blowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V238000·2016-04-25

    Winnebago Recalls 2014 Tour and Itasca Ellipse for Brake Signal Defect

    Winnebago is recalling 2014 Tour and Itasca Ellipse motorhomes because the brake signal to towed devices may not deactivate, causing dragging brakes and fire risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA TOUR, ELLIPSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V239000·2016-04-25

    Pitts Trailers Recall 2014-2016 Models Due to Suspension Weld Cracks

    Pitts Enterprises is recalling 2014-2016 logging trailers because suspension welds may crack, causing the suspension to shift or detach and increasing crash risk.

    Product
    PITTS TRAILERS — PITTS TRAILERS PT, LT, LP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V240000·2016-04-25

    Chrysler Recalls 2012-2015 Vehicles for Transmission Warning Defect

    Chrysler is recalling specific 2012-2015 Dodge, Chrysler, and Jeep vehicles because they may fail to warn drivers when exiting while in gear, posing a rollaway risk.

    Product
    DODGE — DODGE, CHRYSLER, JEEP CHARGER, 300, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V235000·2016-04-22

    Vermeer Recalls 2015-2016 TLR33 Trailers Due to Undersized Tires

    Vermeer is recalling 2015-2016 TLR33 trailers because undersized tires may rub against fenders, increasing the risk of sudden tire failure and a crash.

    Product
    VERMEER — VERMEER TLR33
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E037000·2016-04-22

    Freedman Seating Recalls School Bus Seats Due to Bolt Failure

    Freedman Seating is recalling specific school bus seats manufactured in January 2016 because bolt failure may cause the seat to separate from the base frame during a crash.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V236000·2016-04-22

    Toyota and Scion vehicles recalled for incorrect load capacity labels

    NHTSA is recalling 2016 Toyota and Scion vehicles because the load carrying capacity label may be incorrect, potentially leading to vehicle overload.

    Product
    TOYOTA — TOYOTA, SCION 4RUNNER, LAND CRUISER, YARIS, IM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowNHTSA·16V237000·2016-04-22

    Forest River Recalls Prime Time Crusader Trailers for Incorrect Federal Placard

    Forest River is recalling 2015-2017 Prime Time Crusader trailers because the Federal Placard incorrectly lists the Cargo Carrying Capacity. Dealers will install corrected placards free of charge.

    Product
    PRIME TIME — PRIME TIME CRUSADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·031-2016·2016-04-21

    Meating Place Recalls Beef Patties Due to Possible E. Coli O157:H7 Contamination

    Meating Place is recalling approximately 325 pounds of ground beef patties that may be contaminated with E. coli O157:H7. The product was shipped to retail and institutional locations in the Buffalo, NY area.

    Product
    Meating Place Lorigo's Meating Place Inc. — Meating Place Recalls Beef Product Due to Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V232000·2016-04-21

    Hyundai Recalls Sonata and Elantra Vehicles for Air Bag Defect

    Hyundai is recalling specific 2015-2017 Sonata, Sonata Hybrid, and Elantra vehicles because the driver's frontal air bag may fail to fully deploy in a crash.

    Product
    HYUNDAI — HYUNDAI ELANTRA, SONATA HYBRID, SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V233000·2016-04-21

    Terex Recalls 2001-2003 Aerial Devices Due to Weak Boom Material

    Terex is recalling 2001-2003 XT52, XT55, and XT60 aerial devices because lower booms may be made of insufficiently strong material, posing a risk of cracking and injury.

    Product
    TEREX — TEREX XT60, XT52, XT55
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1048-2016·2016-04-20

    National Fish & Seafood Recalls Raw Shrimp Due to Salmonella Risk

    National Fish & Seafood, Inc. is recalling raw shrimp products due to a potential Salmonella contamination. The recall covers 17 states.

    Product
    MATLAW'S Raw - EZ Peel - Deveined - Shell On Shrimp. NET WT. 2 LBS (32 OZ.) .907 KG (8-12 COUNT PER POUND), packaged in a plastic bag. The plastic bags are shipped in a cardboard master carton, which is labeled in part " MATLAW'S INDIVIDUALLY QUICK FROZEN FROZEN SHRIMP Farm Rai
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-1068-2016·2016-04-20

    Azuma Foods Recalls Seasoned Squid Salad Due to Listeria Contamination

    Azuma Foods International is recalling specific lots of seasoned squid salad after customers in Europe reported positive Listeria monocytogenes test results.

    Product
    Chuka Ika Sansai ECO - International name and Natural Chuka Ika Sansai for US (Seasoned Squid Salad); Net Wt.: 4.4 lbs. (2 kg) for US customer: 2.2 lbs. (1 kg) for European customer. Second lot: Net Wt. 2.2 lbs (8 pkg/1 kg) for European customer 4.4.lbs (2 kg) Shelf lif
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1066-2016·2016-04-20

    Tuna Salad Sandwich Recalled for Undeclared Milk Allergen

    Northern Tier Bakery is recalling Tuna Salad Sandwiches sold in Minnesota and Wisconsin due to an undeclared milk allergen.

    Product
    Tuna Salad Sandwich, Net Wt. 4.5 oz (128g) sold under the following brands and UPC: 1. SuperMom's Bakery, UPC: 76391380124; 2. TakeAway Cafe, UPC: 76391310702; 3. Express Cafe, UPC: 76391380124 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1393-2016·2016-04-20

    RTI Surgical Streamline OCT Final Driver Recalled for Fracture Risk

    RTI Surgical is recalling Streamline OCT Final Drivers due to reduced mechanical strength that may cause the tip to fracture during use.

    Product
    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1453-2016·2016-04-20

    Customed Hip and Knee Replacement Surgical Pack Recall for Sterilization Issues

    Customed, Inc. is recalling 18 units of Hip and Knee Replacement Surgical Packs due to inadequate sterilization validation and package integrity concerns.

    Product
    Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1422-2016·2016-04-20

    Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 15 units of Plastic Surgery Packs (Catalog Number 9001402) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1067-2016·2016-04-20

    Uoriki Octopus Salad Recalled for Listeria monocytogenes Contamination

    Uoriki Fresh Inc is recalling Uoriki Octopus Salad packaged at Wegman's deli counters in New Jersey due to potential Listeria monocytogenes contamination.

    Product
    Uoriki Octopus Salad Net Weight 2.5 lbs Two 2.5lbs pack per case packaged in Black trays covered w/cryovac 10k film no barcode. packaged at Wegman's deli counter for further consumption.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1035-2016·2016-04-20

    JRZ Dairy Recalls Puredesi and Puredahi Low Fat Yogurt for Pasteurization Issues

    JRZ Dairy Products Inc. is recalling specific containers of Puredesi and Puredahi Low Fat Yogurt because the products were not pasteurized for the required length of time.

    Product
    Puredesi Low Fat Yogurt in 2 lb. plastic containers Puredesi Low Fat Yogurt in 5 lb. plastic containers Puredahi Low Fat Yogurt in 2 lb. plastic containers
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1034-2016·2016-04-20

    JRZ Dairy Products Recalls Yogurt for Pasteurization Failure

    JRZ Dairy Products Inc. is recalling three brands of whole milk yogurt because the products were not pasteurized for the required length of time.

    Product
    Puredesi Whole Milk Yogurt in 5 lb. plastic containers Patidar Whole Milk Yogurt in 5 lb. plastic containers Puredahi Whole Milk Yogurt in 5 lb. plastic containers Sell by: 5/08/2016
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V227000·2016-04-20

    Starcraft Bus Recalls 2015-2016 Prodigy and Quest School Buses

    Forest River is recalling 2015-2016 Starcraft Prodigy and Quest school buses because seats may separate from the base frame due to bolt failure.

    Product
    STARCRAFT BUS — STARCRAFT BUS QUEST, PRODIGY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V230000·2016-04-20

    Jayco Recalls 2016 Octane Super Lite Travel Trailers for Fire Risk

    Jayco is recalling 322 model year 2016 Octane Super Lite travel trailers because they may lack a 30-amp circuit breaker, increasing the risk of fire during an electrical short.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER OCTANE SUPER LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1481-2016·2016-04-20

    Customed Laparoscopy-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 36 units of Laparoscopy-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·16V226000·2016-04-20

    StarTrans Senator II Transit Buses Recalled for Seat Separation Risk

    Forest River is recalling 2016 StarTrans Senator II transit buses because seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    STARTRANS — STARTRANS SENATOR II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2016·2016-04-20

    Customed Wound Management Tray III Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 620 Wound Management Tray III units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1493-2016·2016-04-20

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 25 arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1450-2016·2016-04-20

    Customed Minor Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 344 Minor Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1480-2016·2016-04-20

    Customed Utility Drapes Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 800 units of Utility Drapes with Tape, SMS, due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1414-2016·2016-04-20

    Customed Wound Management Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,088 Wound Management Trays because sterilization processes and package integrity were not adequately validated.

    Product
    Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·16V229000·2016-04-20

    Jaguar Recalls XF Vehicles Due to Driver Air Bag Defect

    Jaguar is recalling certain 2009, 2011, 2012, and 2015 XF vehicles because the driver frontal air bag may deploy improperly, increasing injury risk.

    Product
    JAGUAR — JAGUAR XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1026-2016·2016-04-20

    Gold Medal Cincinnati Style Chili Recalled for Undeclared Milk

    Gold Medal Products is recalling 4 lb jars of Cincinnati Style Chili because the label failed to declare milk as an ingredient.

    Product
    #2473 CINCINNATI STYLE CHILI Savory Net Wt. 4 lbs (1.8kg) UPC 0 90939 12473 1 GOLD MEDAL PRODUCTS 10700 MEDALLION DRIVE CINCINNATI, OHIO 45241
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-1488-2016·2016-04-20

    Customed sterile skin staple remover recalled for sterilization validation issues

    Customed, Inc. is recalling 580 sterile skin staple removers distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1372-2016·2016-04-20

    Maquet Recalls HLS Set Advanced Oxygenator Tubing Packs Due to Endotoxin Risk

    Maquet Cardiovascular is voluntarily recalling HLS Set Advanced oxygenator tubing packs due to a potential risk of exposure to endotoxin.

    Product
    HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2016·2016-04-20

    Customed Fan Fold Sheets Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,920 fan fold sheets distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1434-2016·2016-04-20

    Customed Urology Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 25 units of Urology Surgical Packs (Catalog No. 9001738) due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1468-2016·2016-04-20

    Customed Cesarean Section Surgical Packs Recalled for Sterilization Defects

    Customed, Inc. is recalling 96 Cesarean Section Surgical Packs due to inadequate sterilization validation and package integrity issues.

    Product
    Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1469-2016·2016-04-20

    Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 44 Labor and Delivery Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1369-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues

    ICU Medical is recalling 49 units of the Diana Automated Compounding System because it may not meet accuracy specifications when mixing volumes under 5ml.

    Product
    Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2016·2016-04-20

    Customed Basic Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 55 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1381-2016·2016-04-20

    GE Healthcare Recalls Aisys CS2 Anesthesia Devices Due to Bolus Issue

    GE Healthcare is recalling Aisys CS2 and upgraded Aisys anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.

    Product
    GE Healthcare, Aisys CS2 anesthesia..
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Food)·F-1074-2016·2016-04-20

    Hidden Valley Original Ranch Dressing Recalled for Missing Soy Label

    The Clorox Company is recalling Hidden Valley Original Ranch dressing because some bottles are missing the soy lecithin ingredient declaration.

    Product
    Hidden Valley Original Ranch dressing, 16 fl oz. ( 473 ml). plastic bottles; Ingredients: Vegetable oil (soybean and/or Canola oil) water, egg yolk, sugar, Salt, Cultured non fat buttermilk, natural flavors (milk, soy), less than 1% spiced, dried garlic, dried onion, vinegar,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2016·2016-04-20

    Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 150 Pery-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1405-2016·2016-04-20

    Customed Wound Closure Tray I Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Wound Closure Tray I units due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1367-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues

    ICU Medical is recalling 4 units of the Diana Automated Compounding System because compounded volumes under 5ml may not meet accuracy specifications.

    Product
    Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risk

    Synthes (USA) Products LLC is recalling 289 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if a surgeon attempts to remove it.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1406-2016·2016-04-20

    Customed Wound Closure Tray II Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 600 units of Wound Closure Tray II in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1486-2016·2016-04-20

    Customed Carpal Tunnel Surgical Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 162 carpal tunnel surgical packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.

    Product
    Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1477-2016·2016-04-20

    Customed Basic Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 10 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1463-2016·2016-04-20

    Customed Cysto TUR Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 72 Cysto TUR Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1412-2016·2016-04-20

    Customed Foley Catheter Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,920 Foley catheter trays distributed in Puerto Rico due to inadequate sterilization process validation and package integrity.

    Product
    Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1459-2016·2016-04-20

    Customed Urethral Catheter Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,450 Urethral Catheter Trays (14FR) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1377-2016·2016-04-20

    Intuitive Surgical Recalls da Vinci S Surgical System User Manuals

    Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using non-approved instruments with ablation probes may increase microscopic metallic particulates.

    Product
    da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments inclu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2016·2016-04-20

    Maquet QUADROX-i oxygenators recalled for potential endotoxin exposure

    Maquet Cardiovascular is voluntarily recalling QUADROX-i oxygenators and tubing packs due to a potential risk of endotoxin exposure.

    Product
    QUADROX-i oxygenators Custom tubing packs for the oxygenator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2016·2016-04-20

    Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 76 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1424-2016·2016-04-20

    Customed Wound Management Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 200 Wound Management Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1487-2016·2016-04-20

    Customed Incision and Drainage Trays Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 800 Incision and Drainage Trays due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1455-2016·2016-04-20

    Customed Open Heart Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 47 Open Heart Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1436-2016·2016-04-20

    Customed Minor Laceration Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 3,700 Minor Laceration Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1408-2016·2016-04-20

    Customed Peri-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 30 Peri-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1441-2016·2016-04-20

    Customed Knee Arthroscopy Surgical Pack Recalled for Sterilization Defects

    Customed, Inc. is recalling 12 units of Knee Arthroscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1443-2016·2016-04-20

    Customed Lithotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 150 Lithotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1409-2016·2016-04-20

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 16 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1380-2016·2016-04-20

    Philips EPIQ Ultrasound Systems Recalled for Control Panel Fastener Loosening

    Philips is recalling EPIQ diagnostic ultrasound systems because fasteners securing the control panel may loosen, potentially causing the assembly to detach.

    Product
    EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonata
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2016·2016-04-20

    Customed Basic Surgical Pack IV Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 30 units of Basic Surgical Pack IV in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1442-2016·2016-04-20

    Customed Femoral Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 24 femoral surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state

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