October 2016 recalls

1,035 recalls were announced in October 2016.

What the numbers show

Critical: 136
Severe: 305
High: 392
Moderate: 171
Low: 31

Of the 1,035 recalls this month scored against our rubric, 13% are Critical, 29% are Severe.

Which agencies issued them

801–900 of 1035

SevereFDA (Food)·F-2526-2016·2016-10-12
Rabbit Creek Products Recalls Brownie Mixes Due to E. coli O121 Contamination
Rabbit Creek Products Inc. is recalling specific brownie mixes because the flour used may be contaminated with E. coli O121. Consumers should stop using the product.
Product
Mississippi Mudd Brownie Mix (Chocolate Brownie with Fudge Icing), packaged in a plastic bag which is placed in a cardboard box, net wt. 17oz, UPC 010749011793; The Woods brand is labeled as Polly's Mississippi Mudd Brownie Mix (Chocolate Brownie with Fudge Icing)
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2574-2016·2016-10-12
Rabbit Creek Cheesy Garlic Quick Bread Mix Recalled for E. coli O121
Rabbit Creek Products Inc. is recalling Cheesy Garlic Quick Bread Mix because it may contain flour contaminated with E. coli O121.
Product
Cheesy Garlic Quick Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.5oz, UPC 010749008359
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0004-2017·2016-10-12
The Apothecary Shoppe Recalls Tri-Mix 18/1/10 Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling Tri-Mix 18/1/10 vials because the medication was sterilized using a recalled filter, raising concerns about sterility assurance.
Product
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-2568-2016·2016-10-12
Rabbit Creek Garlic & Cheese Bread Mix Recalled for E. coli O121
Rabbit Creek Products Inc. is recalling Garlic & Cheese Olive Oil Bread Mix because the flour used may have been contaminated with E. coli O121.
Product
Garlic & Cheese Olive Oil Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.5oz, UPC 010749009134
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2537-2016·2016-10-12
Rabbit Creek Triple Chocolate Brownie Mix Recalled for E. coli O121
Rabbit Creek Products Inc. is recalling Triple Chocolate Brownie Mix with Cream Cheese Icing because it may contain flour contaminated with E. coli O121.
Product
Triple Chocolate Brownie Mix with Cream Cheese Icing, packaged in a plastic bag which is placed in a cardboard box, net wt. 16oz, UPC 010749011564
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2520-2016·2016-10-12
Rabbit Creek Creme Brulee Brownie Mix Recalled for E. coli O121
Rabbit Creek Products Inc. is recalling Creme Brulee Brownie Mix because the flour used may have been contaminated with E. coli O121.
Product
Creme Brulee Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 11.95oz, UPC 010749011502
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·16V729000·2016-10-12
Ducati Recalls 2016-2017 XDiavel Motorcycles for Side Stand Defect
Ducati is recalling 2016-2017 XDiavel motorcycles because a loose side stand screw may cause the bike to fall or the engine to stall.
Product
DUCATI — DUCATI XDIAVEL
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-2629-2016·2016-10-12
CHS Inc. Recalls Ultra-Soy Imitation Bacon Bits Due to Salmonella
CHS Inc. is recalling 1,200 boxes of Ultra-Soy Imitation Bacon Flavored Bits after testing detected Salmonella in the finished product.
Product
Ultra-Soy Imitation Bacon Flavored Bits-B163, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Category
Food
Distribution
4 states
SevereFDA (Food)·F-2631-2016·2016-10-12
CHS Inc. Recalls Ultra-Soy Imitation Bacon Flavored Chiplets Due to Salmonella
CHS Inc. is recalling Ultra-Soy Imitation Bacon Flavored Chiplets because finished product testing detected Salmonella.
Product
Ultra-Soy Imitation Bacon Flavored Chiplets-B100, packaged in a 25lb and 10lb boxes, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Category
Food
Distribution
4 states
SevereFDA (Food)·F-2490-2016·2016-10-12
Rabbit Creek Cappuccino Muffin Mix Recalled for E. coli O121 Contamination
Rabbit Creek Products Inc. is recalling Cappuccino with Chocolate Chips Muffin Mix because the flour used may be contaminated with E. coli O121.
Product
Cappuccino with Chocolate Chips Muffin Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.1oz, UPC 010749010765
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2633-2016·2016-10-12
CHS Inc Recalls Ultra-Soy Textured Vegetable Protein Due to Salmonella
CHS Inc is recalling 158 bags of Ultra-Soy Textured Vegetable Protein after testing found Salmonella. The product was shipped to five US states and Guyana.
Product
Ultra-Soy Textured Vegetable Protein-BS104, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Category
Food
Distribution
4 states
SevereFDA (Food)·F-2546-2016·2016-10-12
Rabbit Creek Buffalo Wing Beer Bread Mix Recalled for E. coli O121
Rabbit Creek Products is recalling Buffalo Wing Beer Bread Mix because the flour used may have been contaminated with E. coli O121.
Product
Buffalo Wing Beer Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.6oz, UPC 010749007864
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2558-2016·2016-10-12
Paddy's Pub Classic Beer Bread Mix Recalled for E. coli O121 Contamination
Rabbit Creek Products Inc. is recalling Paddy's Pub Classic Beer Bread Mix because it may contain flour contaminated with E. coli O121.
Product
Paddy's Pub Classic Beer Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15oz, UPC 010749008212
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2421-2016·2016-10-12
Treehouse Foods Recalls Peanut Butter Dark Chocolate Protein Bars
Treehouse Foods is recalling multiple brands of peanut butter dark chocolate protein bars due to potential contamination with Listeria monocytogenes from sunflower seeds.
Product
UPC 1373312015, Meijer Peanut Butter Dark Chocolate Protein Bars,Best By/Date Code: DEC 05 16, JAN 04 17. UPC 3225108607, Family Gourmet Peanut Butter Dark Chocolate Protein ,Bars Best By/Date Code: JAN 04 17. UPC 3680039453, Food Club Peanut Butter Dark Chocolate…
Category
Food
Distribution
38 states
SevereFDA (Food)·F-2525-2016·2016-10-12
Rabbit Creek Brownie Mix Recalled Due to E. coli O121 Contamination
Rabbit Creek Products Inc. is recalling Million Dollar Brownie Mix because it may contain flour contaminated with E. coli O121. Consumers should stop using the product.
Product
Million Dollar Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 12.7oz, UPC 010749011540
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2593-2016·2016-10-12
Rabbit Creek Bread Mix Recalled for E. coli O121 Contamination
Rabbit Creek Products is recalling Flower Pot Parmesan Southwest Beer Bread Mix because it may contain flour contaminated with E. coli O121.
Product
Flower Pot Parmesan Southwest Beer Bread Mix, packaged in a plastic bag which is placed in clay pot, net wt. 16.5oz, UPC 010749800823
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2409-2016·2016-10-12
Treehouse Foods Recalls Sunflower Kernels for Listeria Contamination
Treehouse Foods is recalling Nature's Harvest Sunflower Kernels, Ranch Flavored, due to potential contamination with Listeria monocytogenes.
Product
UPC 071725728074, Natures Harvest Sunflower Kernels Ranch Flavored, Best By/Date Code: 3/1/2017, 3/31/2017, 4/27/2017.
Category
Food
Distribution
38 states
SevereFDA (Food)·F-2452-2016·2016-10-12
Treehouse Foods Recalls Nice! Peanut Lovers Trail Mix for Listeria Risk
Treehouse Foods is recalling Nice! Peanut Lovers Trail Mix because it may contain sunflower seeds contaminated with Listeria monocytogenes.
Product
UPC 049022846524 Nice! Peanut Lovers Trail Mix., Best By/Date Code: 4/19/2017.
Category
Food
Distribution
38 states
SevereFDA (Food)·F-2572-2016·2016-10-12
Rabbit Creek Caramel Pecan Quick Bread Mix Recalled for E. coli O121
Rabbit Creek Products Inc. is recalling Caramel Pecan with Streusel Topping Quick Bread Mix because it may contain flour contaminated with E. coli O121.
Product
Caramel Pecan with Streusel Topping Quick Bread Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 18.25oz, UPC 010749008700
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2530-2016·2016-10-12
Rabbit Creek Brownie Mix Recalled for E. coli O121 Contamination
Rabbit Creek Products Inc. is recalling Raspberry with Cabernet Wine Brownie Mix because it may contain flour contaminated with E. coli O121.
Product
Raspberry with Cabernet Wine Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 10.8oz, UPC 010749040212
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2531-2016·2016-10-12
Rabbit Creek Brownie Mix Recalled for E. coli O121 Contamination
Rabbit Creek Products is recalling Redneck Brownie Mix because it may contain flour contaminated with E. coli O121.
Product
Redneck (Potato Chip & Bacon) Brownie Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 12oz, UPC 010749111165
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2436-2016·2016-10-12
Treehouse Foods Recalls Nut Trail Mixes Due to Listeria Risk
Treehouse Foods is recalling specific Amport Foods and Naturally Select nut trail mixes because they may contain sunflower seeds contaminated with Listeria monocytogenes.
Product
UPC 071725713124, Amport Foods Chocolatey Nut Trail Mix, Best By/Date Code: 1/8/2017 . UPC 639277431417, Naturally Select Chocolate & Nut Trail Mix, Best By/Date Code: 3/23/2017 .
Category
Food
Distribution
38 states
SevereFDA (Food)·F-2611-2016·2016-10-12
Greenberg Fruit Co Recalls Diced Potatoes Due to Listeria
Greenberg Fruit Co is recalling diced potatoes labeled 'Joe's Pride' because routine environmental tests detected Listeria monocytogenes on processing machines.
Product
potato/diced, Label states "Joe's Pride" and bears the address 9705 I Street, Omaha, NE 68127. Product is packaged in poly bags inside cardboard boxes. All products have a best by date of 12 days after the production date.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0015-2017·2016-10-12
Siemens Recalls Ysio Max Radiographic Systems Due to Table Tilt Risk
Siemens is recalling 37 Ysio Max radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.
Product
YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0051-2017·2016-10-12
Argon Medical Devices Recalls MicroStic Plus Sheaths Due to Dilator Hub Defect
Argon Medical Devices is recalling 200 units of MicroStic Plus sheaths because the dilator hub is too small to secure the dilator to the sheath.
Product
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
Category
Medical Device
Distribution
2 states
HighNHTSA·16V731000·2016-10-12
Ford Recalls 2017 Lincoln Continental Vehicles for Headlight Defect
Ford is recalling 2017 Lincoln Continental vehicles because incorrect headlight lenses may reduce turn signal visibility, increasing crash risk.
Product
LINCOLN — LINCOLN CONTINENTAL
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2908-2016·2016-10-12
Integra Drainage Accessory Kits Recalled Due to Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling specific lots of Integra Drainage Accessory Kits because a final inspection found an incomplete packaging seal, potentially compromising sterility.
Product
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2472-2016·2016-10-12
Savory Foods Recalls Peanut Butter Cookie Dough for Listeria Risk
Savory Foods, Inc. is voluntarily recalling Pre-Portion Master Dough (Peanut Butter) due to potential Listeria monocytogenes contamination.
Product
PRE-PORTION MASTER DOUGH (PEANUT BUTTER)- Raw cookie dough with 192 pucks/case
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0041-2017·2016-10-12
Trumpf Medical Systems Recalls Stationary Column TruSystem 7599 Operating Tables
Trumpf Medical Systems is recalling 84 Stationary Column TruSystem 7599 units because they may unexpectedly descend approximately 20 centimeters.
Product
Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating…
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0043-2017·2016-10-12
Trumpf Medical Systems Recalls TruSystem Operating Tables Due to Unexpected Descent
Trumpf Medical Systems is recalling 84 TruSystem 7000 U operating tables because they may unexpectedly descend approximately 20 centimeters.
Product
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the…
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0042-2017·2016-10-12
Trumpf Medical Systems Recalls Floor Mounting Columns for Unexpected Descent
Trumpf Medical Systems is recalling 84 Floor Mounting Columns because they unexpectedly descended approximately 20 centimeters, posing a risk to patient safety during surgery.
Product
Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table…
Category
Medical Device
Distribution
10 states
HighFDA (Food)·F-2606-2016·2016-10-12
Apple Pecan Cake Recalled for Missing Pecan Allergen Labeling
Creative Occasions, Inc. is recalling Patti's good life Premium Apple Pecan Cake because the ingredient statement failed to declare pecans.
Product
Patti's good life PREMIUM APPLE PECAN CAKE, NET WT 20 OZ (1 LB 4 OZ) 567g, UPC 89028800290
Category
Food
Distribution
10 states
HighNHTSA·16V732000·2016-10-12
Coachmen Galleria Recalled for Incorrect Cargo Capacity Placard
Forest River is recalling 2016-2017 Coachmen Galleria recreational vehicles because the cargo capacity placard is inaccurate, which may lead to overloading.
Product
COACHMEN — COACHMEN GALLERIA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·16V730000·2016-10-12
ShowHauler Garage Coach Lift Gate Chain Recall
ShowHauler is recalling 2014-2015 Garage Coaches because lift gate roller chains may fail, causing the platform to drop and increasing injury risk.
Product
SHOWHAULER — SHOWHAULER GARAGE COACH
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-2307-2016·2016-10-12
Four Seasons Pecan Tarts Recalled for Undeclared Milk
Charlie's Specialties, Inc. is recalling Four Seasons Pecan Tarts because they contain undeclared milk. The product was distributed in Ohio.
Product
Four Seasons Pecan Tarts; 202 4T0867 ; Sel By: 09/10/2016, 09/15/15, 10/13/16,10/28/16; and 12/10/15, 12/15/15, 01/13/16, 01/28/16 (lot numbers). 180 Pieces; Weight 8#; Packed exclusively for International Market Brands, Cleveland, Ohio 44146.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0013-2017·2016-10-12
Siemens Recalls Multix Fusion X-Ray Systems Due to Table Tilt Risk
Siemens is recalling 37 Multix Fusion X-ray systems because an internal table part may detach, causing the table to tilt and potentially injure patients.
Product
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0005-2017·2016-10-12
Progressive Gourmet Recalls Sausage, Egg, and Cheese Muffins for Listeria Risk
Progressive Gourmet Inc. is recalling frozen Sausage, Egg, and Cheese on English Muffin products manufactured for Starbucks due to Listeria monocytogenes contamination found on food contact surfaces.
Product
Sausage, Egg, and Cheese on English Muffin, Fully Cooked, Keep Frozen, Perishable-30/case Manufactured Exclusively for Starbucks Coffee Company, Seattle, WA 98134 Product Date: 10/FEB/2016 SKU: 11041857 Not Labeled for Retail Sale
Category
Food
Distribution
6 states
HighFDA (Food)·F-2639-2016·2016-10-12
Martinelli Sparkling Cider Gift Baskets Recalled for Potential Glass Chips
DesignPac Gifts is recalling Elegant Sophistication gift baskets containing Martinelli Sparkling Cider due to a risk of glass chips entering the beverage.
Product
Elegant sophistication gift basket containing apple cidar in glass bottles. The label on the back of the gift basket is white with black lettering.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0038-2017·2016-10-12
RayStation Radiation Therapy Planning Software Recalled for Dose Calculation Errors
RaySearch is recalling RayStation software versions 2.5 through 5.0 due to dose calculation errors when using specific region of interest settings.
Product
RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2905-2016·2016-10-12
Integra Straight Ventricular Catheter Recalled for Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling 10 units of Straight Ventricular Catheters due to an incomplete packaging seal discovered during final inspection.
Product
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2909-2016·2016-10-12
Integra Ventricular Catheter Accessory Kit Recalled for Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling 14 units of the Ventricular Catheter Accessory Kit due to an incomplete sterile packaging seal discovered during final inspection.
Product
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0039-2017·2016-10-12
Siemens Dimension Vista Calcium Reagent Cartridge Recall for Erroneous Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Calcium reagent cartridges that may produce inaccurate test results.
Product
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0014-2017·2016-10-12
Siemens Recalls Multix Fusion VA10 Radiographic Systems Due to Table Defect
Siemens is recalling 37 Multix Fusion VA10 radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.
Product
Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0008-2017·2016-10-12
Microgenics Recalls QMS Everolimus Assay Due to Reagent Stability Issue
Microgenics Corporation is recalling the Thermo Scientific QMS Everolimus Assay because a reagent stability issue causes inaccurate test results for transplant patients.
Product
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0003-2017·2016-10-12
Zimmer Biomet Recalls Vanguard 360 Knee Prostheses Due to Bolt Defect
Zimmer Biomet is recalling 454 Vanguard 360 Revision Knee System prostheses because a manufacturing defect in the tibial augment bolts may prevent them from being fully tightened during surgery.
Product
Vanguard 360 Revision Knee System Knee prostheses
Category
Medical Device
Distribution
9 states
HighCPSC·17010·2016-10-12
Mamas & Papas Recalls Armadillo Strollers Due to Fall Hazard
Mamas & Papas is recalling Armadillo Flip and Flip XT strollers because a loose latch can cause the seat to tip back, posing a fall hazard to infants.
Product
Mamas & Papas Armadillo Flip Strollers
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0045-2017·2016-10-12
LDR Spine Recalls ROI-A Anterior Delivery Device Due to Binding
LDR Spine USA is recalling 24 units of the ROI-A Anterior Delivery Device because the T-handle rotation has experienced binding. No patient injuries have been reported.
Product
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
Category
Medical Device
Distribution
7 states
HighNHTSA·16V728000·2016-10-12
Forest River Recalls 2017 Trailers Due to Air Conditioner Fire Risk
Forest River is recalling 2017 Flagstaff and Rockwood trailers because excess slack in air conditioner wiring may contact heating elements, increasing fire risk.
Product
FOREST RIVER — FOREST RIVER ROCKWOOD, FLAGSTAFF
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0016-2017·2016-10-12
Panoramic PC-1000 X-ray Systems Recalled for Safety Nut Defect
Panoramic Rental Corp. is voluntarily correcting PC-1000 X-ray systems because a safety nut may be ineffective, posing a risk of blunt force trauma to the head, neck, or shoulders.
Product
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·16V727000·2016-10-12
Keystone Recalls 2017 Dutchmen Coleman Trailers for Wiring Fire Risk
Keystone RV is recalling 84 model year 2017 Dutchmen Coleman recreational trailers because loose or frayed wiring in the power center may increase the risk of a fire.
Product
DUTCHMEN — DUTCHMEN COLEMAN
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0005-2017·2016-10-12
Teva Recalls Claravis Isotretinoin Capsules Due to Impurity Failures
Teva North America is recalling Claravis (isotretinoin) capsules because they failed impurity and degradation specifications.
Product
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0024-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A3.5 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 17 units of Zenostar MT Color A3.5 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0047-2017·2016-10-12
Toshiba Aquilion RXL CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion RXL CT scanners because a reconstruction error may interrupt scans if the range exceeds the maximum field of view.
Product
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-2906-2016·2016-10-12
Integra CUSA Dissectron Fingertip Laparoscopic Cannula Recalled for Packaging Seal Defect
Integra LifeSciences is recalling 9 units of CUSA Dissectron Fingertip Laparoscopic Cannulas due to incomplete sterile packaging seals discovered during final inspection.
Product
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0042-2017·2016-10-12
Wegmans Italian Classics Ricotta & Spinach Ravioli Recalled for Plastic Contamination
Wegmans is recalling Italian Classics Ricotta & Spinach Striped Jumbo Ravioli because the product may contain pieces of white plastic.
Product
Wegmans ITALIAN CLASSICS RICOTTA & SPINACH STRIPED JUMBO RAVIOLI, NET WT 9 OZ. (255g), UPC 0-77890-38934, KEEP REFRIGERATED -- Distributed By: Wegmans Foods Markets, Inc. Rochester, NY 14603, Product of Canada --- Packaged in a plastic tray and sold in a refrigerated case in the…
Category
Food
Distribution
6 states
ModerateFDA (Drugs)·D-0008-2017·2016-10-12
West-Ward Recalls Prednisone Tablets Due to Underweight Specification Failure
West-Ward Pharmaceuticals is recalling 15,109 bottles of Prednisone 1 mg tablets because an underweight tablet was discovered.
Product
PREDNISONE — PREDNISONE (PREDNISONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0018-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Brown Dental Porcelain
Ivoclar Vivadent is recalling 11 units of Zenostar MT Color Impulse brown dental porcelain due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0012-2017·2016-10-12
Philips Ingenuity CT Scanner Recalled for Infant Head Image Quality Issues
Philips Medical Systems is recalling 235 Ingenuity CT scanners because infant head scans in High Resolution mode may produce degraded image quality, including non-uniformity and CT number shifts.
Product
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0017-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Blue Dental Porcelain
Ivoclar Vivadent is recalling 79 units of Zenostar MT Color Impulse blue dental porcelain due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0032-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 13 units of Zenostar MT Color C3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0049-2017·2016-10-12
Toshiba Celesteion CT Scanner Recalled for Potential Reconstruction Errors
Toshiba is recalling 165 Celesteion CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum field of view.
Product
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-0028-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B3 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 27 units of Zenostar MT Color B3 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0048-2017·2016-10-12
Toshiba Aquilion LB CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion LB CT scanners because a reconstruction error may interrupt scanning if the range exceeds the maximum field of view.
Product
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-0027-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 15 units of Zenostar MT Color B2 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2833-2016·2016-10-12
TriFoillmaging CT Scanners Recalled for X-Ray Compliance Issues
Northridge Tri-Modality Imaging is recalling three TriFoillmaging Triumph/Triumph II Research CT scanners because they may not meet federal X-ray safety standards.
Product
TriFoillmaging Triumph/Triumph II Research CT scanners.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0026-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 43 units of Zenostar MT Color B1 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0035-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 18 units of Zenostar MT Color D3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0001-2017·2016-10-12
Ballester Hermanos Recalls Canned Octopus in Oil Due to Mislabeling
Ballester Hermanos, Inc. is recalling canned octopus in oil because the product is actually squid. The recall covers Puerto Rico.
Product
Product in cans of 4 1/4 oz (111g) and 8 1/4 oz (220g) net weight. Label reading in part as: "Coloso***PULPO EN ACEITE***OCTOPUS IN OIL***NET WEIGHT ***Fabricado en Espa¿a (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO…
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0036-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D4 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 9 units of Zenostar MT Color D4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0033-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C4 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 10 units of Zenostar MT Color C4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0023-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 42 units of Zenostar MT Color A3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2916-2016·2016-10-12
New Star Lasers Recalls ReNew Dermatology Devices for Labeling Errors
New Star Lasers is recalling five ReNew laser systems because customers were not notified when promotional material was revised to remove outside-use indications.
Product
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of…
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-0004-2017·2016-10-12
Ballester Hermanos Recalls Canned Octopus in Puerto Rico Due to Mislabeling
Ballester Hermanos, Inc. is recalling 145 cases of canned octopus in Puerto Rico because the product contains squid instead of octopus.
Product
Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO EN SALSA MARINERA***OCTOPUS IN PICKLED SAUCE***NET WEIGHT ***Fabricado en Espa¿a (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO…
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-2642-2016·2016-10-12
Coca-Cola Recalls Sprite Cans Due to Tab Opening Upward
The Coca-Cola Company is recalling specific Sprite and Sprite Zero cans where the tab may open upward instead of downward, causing a loud pop.
Product
Sprite Zero, 12 oz. can/12 pack, UPC 049000037111; Sprite, 12 oz. can/6 pack, UPC N/A; Sprite, 12 oz. can/12 pack, UPC 049000028928; Sprite, 12 oz. can/20 pack, UPC 049000014655
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0050-2017·2016-10-12
Randox IgE Calibrator Series Recall for Value Alignment
Randox Laboratories is recalling IgE Calibrator Series units to align value assignments with the 3rd International Standard for human serum IgE.
Product
IgE Calibrator Series
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2914-2016·2016-10-12
New Star Lasers Recalls CT3Plus and CT3PZ Systems for Labeling Issues
New Star Lasers is recalling 91 CT3Plus and CT3PZ laser systems because customers were not notified when promotional labeling was revised to remove outside-use indications.
Product
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0034-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 40 units of Zenostar MT Color D2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0022-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling Zenostar MT Color A2 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0003-2017·2016-10-12
Ballester Hermanos Recalls Canned Octopus in Hot Oil Due to Mislabeling
Ballester Hermanos, Inc. is recalling 166 cases of canned octopus in hot oil sold in Puerto Rico because the label lists octopus but the product contains squid.
Product
Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO EN ACEITE PICANTE***OCTOPUS IN HOT OIL***NET WEIGHT ***Fabricado en Espa¿a (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO…
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-2641-2016·2016-10-12
Coca-Cola Cans Recalled Due to Tab Opening Upward
The Coca-Cola Company is recalling 14,168 cases of various soda cans where the tab may open upward instead of downward, causing a loud pop.
Product
Coca-Cola, 16 fl. oz. can/12 pack, UPC 049000054318; Coca-Cola, 12 oz. can/12 pack, UPC 049000028904; Coca-Cola Zero, 12 oz. can/12 pack, UPC 049000042559; Diet Coke, 12 oz. can/24 pack, UPC 049000010633; Diet Coke, 12 oz. can/12 pack, UPC 049000028911; Cherry Coke, 12 oz.…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0021-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling Zenostar MT Color A1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0030-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 37 units of Zenostar MT Color C1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2907-2016·2016-10-12
Integra Lumbar Drainage Set Recalled for Incomplete Packaging Seal
Integra LifeSciences is recalling 18 units of Integral Lumbar Drainage Sets due to incomplete sterile packaging seals discovered during final inspection.
Product
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0010-2017·2016-10-12
Philips CT Scanner Recall for Infant Head Image Quality Defects
Philips is recalling 358 Ingenuity Core CT scanners because infant head scans may show degraded image quality, including non-uniformity and CT number shifts.
Product
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0011-2017·2016-10-12
Philips Ingenuity Core 128 CT Scanner Recalled for Image Quality Defects
Philips Medical Systems is recalling 524 Ingenuity Core 128 CT scanners because high-resolution head scans may produce degraded image quality, including non-uniformity and CT number shifts.
Product
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0046-2017·2016-10-12
Toshiba Aquilion Lightning CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion Lightning CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum Field of View.
Product
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-2910-2016·2016-10-12
Integra Lumbar Drainage Set Recalled Due to Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling specific lots of Lumbar Drainage Sets because final inspection revealed an incomplete packaging seal on the sterile product.
Product
Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0037-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Orange Dental Porcelain
Ivoclar Vivadent is recalling 5 units of Zenostar MT Color Impulse orange dental porcelain due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0002-2017·2016-10-12
Ballester Hermanos Recalls Canned Octopus with Garlic Flavor Due to Mislabeling
Ballester Hermanos, Inc. is recalling 495 cases of Coloso brand canned octopus with garlic flavor in Puerto Rico because the product contains squid instead of octopus.
Product
Product in cans of 4 1/4 oz and 8 1/4 oz net weight. Label reading in part as: "Coloso***PULPO AL AJILLO***OCTOPUS WITH GARLIC FLAVOR***NET WEIGHT ***Fabricado en Espa¿a (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO…
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0031-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 19 units of Zenostar MT Color C2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2915-2016·2016-10-12
New Star Lasers Recalls VariaBreeze Systems Due to Labeling Notification Failure
New Star Lasers is recalling 17 VariaBreeze laser systems because customers were not notified when promotional material was revised to remove outside-use indications.
Product
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0029-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B4 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 7 units of Zenostar MT Color B4 dental porcelain liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2911-2016·2016-10-12
Arrow Recalls Walrus Arterial Embolectomy Catheters Due to Labeling Errors
Arrow International Inc is recalling 2,425 Walrus Arterial Embolectomy Catheters nationwide due to incorrect labeling.
Product
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0020-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Violet Due to Packaging Leaks
Ivoclar Vivadent is recalling 25 units of Zenostar MT Color Impulse violet dental porcelain coloring due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0025-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A4 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 11 units of Zenostar MT Color A4 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0007-2017·2016-10-12
Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failures
Sun Pharmaceutical Industries is recalling 31,762 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications.
Product
BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0009-2017·2016-10-12
Philips Brilliance 64 CT Scanner Recalled for Infant Head Image Quality Issues
Philips Medical Systems is recalling 185 Brilliance 64 CT scanners because infant head scans in High Resolution mode may show degraded image quality.
Product
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2017·2016-10-12
Merit Medical Recalls Inflation Syringe Kits Due to Labeling Errors
Merit Medical Systems is voluntarily recalling 1,297 Inflation Syringe Kits because unit labels are missing required device information.
Product
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0019-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Grey Dental Porcelain
Ivoclar Vivadent is recalling 60 units of Zenostar MT Color Impulse grey dental porcelain due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0001-2017·2016-10-12
Varithena Administration Packs Recalled Due to Incorrect Syringe Type
Biocompatibles is recalling Varithena administration packs because they contain the incorrect type of syringe. The recall covers 3,254 packs distributed nationwide.
Product
VARITHENA — VARITHENA (POLIDOCANOL)
Category
Drug
Distribution
Distributed nationwide

Looking for a different month? Back to 2016.