June 2016 recalls

896 recalls were announced in June 2016.

What the numbers show

Critical: 58
Severe: 256
High: 403
Moderate: 156
Low: 23

Of the 896 recalls this month scored against our rubric, 6% are Critical, 29% are Severe.

Which agencies issued them

701–800 of 896

CriticalFDA (Drugs)·D-0881-2016·2016-06-01
FDA Recalls Weight Loss Product Containing Undeclared Sibutramine and Phenolphthalein
Lucy's Weight Loss System is recalling Shorts on The Beach Golden Edition because it contains undeclared sibutramine and phenolphthalein.
Product
Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0878-2016·2016-06-01
Smart Lipo Dietary Supplement Recalled for Undeclared Dangerous Ingredients
Centro Naturista is recalling Smart Lipo Dietary Supplement capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.
Product
Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0869-2016·2016-06-01
Avastin Syringes Recalled for Bacterial Contamination
AmEx Pharmacy is recalling 45 Avastin syringes nationwide because testing revealed bacterial contamination.
Product
Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0879-2016·2016-06-01
Pink Bikini Strong Formula capsules recalled for undeclared ingredients
Lucy's Weight Loss System is recalling Pink Bikini Strong Formula capsules because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA/ANDA.
Product
Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0882-2016·2016-06-01
Pink Bikini capsules recalled for undeclared dangerous ingredients
Lucy's Weight Loss System is recalling Pink Bikini capsules because they contain undeclared Sibutramine, Phenolphthalein, and/or Diclofenac.
Product
Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0906-2016·2016-06-01
FDA Recalls Super Hard Capsules Marketed Without Approval
R Thomas Marketing, LLC is recalling Super Hard capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0885-2016·2016-06-01
Herb Viagra Recalled for Lack of FDA Approval
R Thomas Marketing, LLC is recalling Herb Viagra because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0886-2016·2016-06-01
Real Skill Recalled for Marketing Without FDA Approval
R Thomas Marketing, LLC is recalling Real Skill capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1759-2016·2016-06-01
American Surgical Cotton Balls Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling 34 boxes of strung cotton balls due to packaging defects that compromise sterility. The products were distributed worldwide.
Product
American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0889-2016·2016-06-01
African Black Ant capsules recalled for lack of FDA approval
R Thomas Marketing, LLC is recalling African Black Ant capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1636-2016·2016-06-01
Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices
Hummingbird Med is recalling Hummi Micro Draw Blood Transfer Devices because the Y connector may separate from the cannula hub during use.
Product
ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
Category
Medical Device
Distribution
5 states
SevereFDA (Drugs)·D-0892-2016·2016-06-01
FDA Recalls Unapproved Zhong Hua Niu Bian Capsules Nationwide
R Thomas Marketing, LLC is recalling Zhong Hua Niu Bian capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0901-2016·2016-06-01
Man King capsules recalled for lack of FDA approval
R Thomas Marketing, LLC is recalling Man King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0867-2016·2016-06-01
Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities
Fresenius Kabi USA is recalling Octreotide Acetate Injection vials because they failed impurities and degradation specifications.
Product
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0899-2016·2016-06-01
Plant Vigra Recalled for Lack of FDA Approval
R Thomas Marketing, LLC is recalling Plant Vigra because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1321-2016·2016-06-01
AA USA Trading Ginger Slices Recalled for Undeclared Sulfites
AA USA Trading Inc. is recalling 8-ounce packages of Ginger Slices because they contain undeclared sulfites. The product was distributed in New York and New Jersey.
Product
AA USA Trading Inc. Ginger Slice Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South River, NJ 08882
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0903-2016·2016-06-01
Night Man capsules recalled for lack of FDA approval
R Thomas Marketing, LLC is recalling Night Man capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0896-2016·2016-06-01
FDA Recalls Black Storm Capsules Marketed Without Approval
R Thomas Marketing, LLC is recalling Black Storm capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0891-2016·2016-06-01
Bull's Genital Recalled for Marketing Without FDA Approval
R Thomas Marketing, LLC is recalling Bull's Genital capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·16V382000·2016-06-01
Audi Recalls A4 and A6 Vehicles Due to Air Bag Inflator Rupture Risk
Volkswagen Group of America is recalling specific Audi A4 and A6 models because passenger air bag inflators may rupture during deployment, potentially causing serious injury or death.
Product
AUDI — AUDI A4, A6
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·16E051000·2016-06-01
M.B. Sturgis Recalls Auto Changeover Propane Gas Regulators Due to Leak Risk
M.B. Sturgis is recalling specific propane gas regulators where a cracked window may allow gas to leak, increasing fire risk. Dealers will replace the parts free of charge.
Product
EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1380-2016·2016-06-01
Sausage Maker Seasoning Recalled for Undeclared Milk Allergens
The Sausage Maker, Inc. is recalling Smoked Pepperoni seasoning because the Fermento ingredient contains undeclared whey protein and skim milk powder.
Product
THE SAUSAGE MAKER SEASONING Smoked Pepperoni under the following labels: 1) Net Wt 2 lbs, 2) Net Wt 25 lbs, 3) Smoked Pepperoni Kit w/Home Pak, 4) Smoked Pepperoni Salami Kit
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1379-2016·2016-06-01
Sausage Maker Seasoning Recalled for Undeclared Milk Allergens
The Sausage Maker, Inc. is recalling Goetburg Summer Sausage seasoning due to undeclared whey protein and skim milk powder.
Product
THE SAUSAGE MAKER SEASONING Goetburg Summer Sausage under the following labels: 1) Net Wt: 2 lbs.8 oz, 2) Goteborg Summer Sausage Kit
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0876-2016·2016-06-01
Akorn Recalls PerioRx Oral Rinse Due to Unknown Impurity
Akorn, Inc. is recalling PerioRx oral rinse because multiple batches failed impurity specifications. The product contains an unknown impurity of chlorhexidine gluconate.
Product
PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0868-2016·2016-06-01
Teva Recalls Linezolid Injection Bags Due to Sterility Concerns
Teva North America is recalling 546 bags of Linezolid Injection due to potential leaking that compromises sterility.
Product
Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0907-2016·2016-06-01
FDA Recalls Zhen Gong Fu for Lack of Approved New Drug Application
R Thomas Marketing, LLC is recalling Zhen Gong Fu capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0884-2016·2016-06-01
FDA Recalls Black Ant Supplements Marketed Without Approval
The FDA is recalling Black Ant supplements distributed by R Thomas Marketing, LLC because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereCPSC·16183·2016-06-01
Southwire Recalls Non-Contact Voltage Detectors Due to Shock and Burn Hazards
Southwire is recalling approximately 1.2 million non-contact voltage detectors because they may provide false readings, posing shock and burn risks.
Product
Non-contact voltage detectors
Category
Consumer Product
Distribution
Distributed nationwide
SevereCPSC·16749·2016-06-01
Mohu Recalls BeBox Smart Boomboxes Due to Burn and Fire Hazards
Mohu is recalling about 1,700 BeBox smart boomboxes because they can overheat, posing burn and fire hazards. One incident of a unit catching fire was reported, with no injuries.
Product
Boombox
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0890-2016·2016-06-01
FDA Recalls Bull Capsules Marketed Without FDA Approval
R Thomas Marketing, LLC is recalling Bull capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereCPSC·16185·2016-06-01
Traxxas Recalls X-Maxx Monster Trucks and Speed Controls for Fire Hazard
Traxxas is recalling X-Maxx Monster Trucks and VXL-6 electronic speed controls because a short circuit can cause a fire. The company reported 40 fires and one injury.
Product
X-Maxx Monster Trucks and VXL-6 electronic speed controls
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1792-2016·2016-06-01
American Surgical Delicot X Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.
Product
American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0861-2016·2016-06-01
Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling 282,080 bags of 0.9% Sodium Chloride Injection USP due to a lack of assurance of sterility caused by potential container leaks.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1284-2016·2016-06-01
Aloha Medicinals Recalls Organic Dried Mushroom Powder Due to E. coli
Aloha Medicinals is recalling organic dried mushroom powder after a sample tested positive for E. coli following customer reports of stomach issues.
Product
Organic Auricularia auricular (Dried Mushroom Powder (Jelly Ear Mushroom). 60 kg 4 mil polyethylene bags inside plastic polyethylene black drum. Certified Organic by QAI - Made in USA. Aloha Medicinals Inc. 2300 Arrowhead Drive Carson City, NV 89706
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0865-2016·2016-06-01
Hospira Recalls Sodium Bicarbonate Injection Due to Insect Particulate Matter
Hospira Inc. is recalling 72,000 units of 8.4% Sodium Bicarbonate Injection because an insect was found in one vial.
Product
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·16V391000·2016-06-01
KZRV Recalls 2016 MXT Travel Trailers Due to Underrated Safety Chains
KZRV is recalling 2016 MXT travel trailers because the safety chains are rated for less weight than the vehicle's gross weight rating, posing a crash risk if the main connection fails.
Product
KZRV — KZRV MXT
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1378-2016·2016-06-01
Sausage Maker Seasoning Recalled for Undeclared Milk Allergens
The Sausage Maker, Inc. is recalling specific seasoning products because they contain undeclared whey protein and skim milk powder.
Product
THE SAUSAGE MAKER SEASONING Dried Sticks Hot under the following labels: 1) Net Wt 2 lbs, 2) Net Wt 25 lbs, 3) Hot Dried Sausage Sticks Kit w/19mm
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·16V387000·2016-06-01
Kia Recalls Sedona Minivans Due to Front Control Arm Corrosion Risk
Kia is recalling 2006-2012 Sedona minivans in specific states because front lower control arms may break due to salt water corrosion, increasing crash risk.
Product
KIA — KIA SEDONA
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1381-2016·2016-06-01
Sausage Maker Seasoning Recalled for Undeclared Milk Ingredients
The Sausage Maker, Inc. is recalling Summer Sausage seasoning due to undeclared whey protein and skim milk powder.
Product
THE SAUSAGE MAKER SEASONING Summer Sausage under the following labels: 1) Net Wt 8 oz, 2) Net Wt 2 lbs. 8 oz., 3 ) Net Wt 25 lbs, 4) Summer Sausage Kit
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0893-2016·2016-06-01
FDA Recalls African Superman Supplements Marketed Without Approval
R Thomas Marketing, LLC is recalling African Superman supplements because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0872-2016·2016-06-01
Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System
Sanofi-Aventis is recalling Auvi-Q epinephrine auto-injectors because a defective delivery system may result in inaccurate dosage delivery.
Product
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0859-2016·2016-06-01
Teva Recalls Amikacin Sulfate Injection Due to Glass Particulate Matter
Teva Pharmaceuticals USA is recalling Amikacin Sulfate injection vials because glass particulate matter was identified in one vial.
Product
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1384-2016·2016-06-01
Unlabeled Dried Yellow Fish Recalled for Being Uneviscerated
WD Import and Export Inc. is recalling 2 cases of unlabeled, whole dried yellow fish from China found to be uneviscerated.
Product
Whole Dried Yellow Fish in bulk cardboard box, unlabeled, Product of China --- Fish measured 6.5 - 7.5 inches in length
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-1823-2016·2016-06-01
Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet, Inc. is recalling specific trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Product
Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0866-2016·2016-06-01
Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities
Fresenius Kabi is recalling specific lots of Octreotide Acetate Injection because they failed impurities and degradation specifications.
Product
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0902-2016·2016-06-01
FDA Recalls Mojo Risen Distributed Without Approved New Drug Application
R Thomas Marketing, LLC is recalling Mojo Risen capsules nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0898-2016·2016-06-01
Happy Passengers Recalled for Lack of FDA Approval
R Thomas Marketing, LLC is recalling Happy Passengers capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·16V392000·2016-06-01
KYMCO Recalls 2016 K-Pipe Motorcycles Due to Reverse Gear Shift Pattern
KYMCO USA is recalling 340 model year 2016 K-Pipe motorcycles because the gear shift pattern was assembled in reverse, which may cause riders to select the wrong gear and increase crash risk.
Product
KYMCO — KYMCO K-PIPE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2016·2016-06-01
Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility.
Product
Various trauma and sports medicine instruments and implants. Bit, drill.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1391-2016·2016-06-01
Kraft Heinz Recalls CapriSun Fruit Punch Due to Glass Fragments
Kraft Heinz is recalling CapriSun fruit punch roarin'waters because of the possible presence of glass fragments. Consumers should stop using the affected products.
Product
CapriSun fruit punch roarin'waters packaged in a blue and white box with pictures of fruit and white lettering.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1780-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling 442 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Product
American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2016·2016-06-01
AngioVac Circuit Packs Recalled for Excessive Endotoxin Levels
AngioDynamics is recalling AngioVac Circuit Packs because they may contain RotaFlow Centrifugal Pumps with endotoxin levels exceeding regulatory limits.
Product
AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1741-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 39 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Product
American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1397-2016·2016-06-01
Jacobsen Corn Seasoning Salt Recalled for Undeclared Milk Allergen
Jacobsen Salt Co. is recalling Corn Seasoning Salt Blue Cheese and Herb because the label declares blue cheese but fails to declare milk.
Product
Corn Seasoning Salt Blue Cheese and Herb. Plastic bottles, 6 bottles per case. various sizes: Wt. 5.7 oz. The UPC is 8 14417 02089 2. Product is labeled in parts: "***CORN SEASONING SALT BLUE CHEESE & HERB***INGREDIENTS: BLUE CHEESE, JACOBSEN SEA SALT, OREGANO…
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1829-2016·2016-06-01
RTI Surgical Recalls Streamline OCT Spinal Fixation Instruments
RTI Surgical is recalling 17 Streamline OCT Crosslink Counter Torque Sleeves because a defect may obstruct the cannula, potentially causing driver slippage and patient injury.
Product
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1753-2016·2016-06-01
American Surgical Cotton Balls Recalled for Packaging Sterility Defect
American Surgical Company is recalling 87 boxes of strung cotton balls due to packaging defects that compromise sterility.
Product
American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1701-2016·2016-06-01
AngioVac Circuit Recall Due to Potential Endotoxin Levels
Angiodynamics is recalling Vortex MEDICAL AngioVac Circuits because they may contain endotoxin levels exceeding regulatory limits.
Product
Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1706-2016·2016-06-01
GE Healthcare Discovery IGS 730 Recalled for Potential Image Loss
GE Medical Systems is recalling 54 Discovery IGS 730 systems due to a risk of non-recoverable loss of image acquisition during procedures.
Product
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1772-2016·2016-06-01
American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 16 boxes distributed worldwide.
Product
American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1729-2016·2016-06-01
American Surgical Americot Blue Sponges Recalled for Packaging Defects
American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall covers 37 boxes distributed worldwide.
Product
American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1806-2016·2016-06-01
American Surgical Telfa Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Telfa 1" x 3" sponges because defective packaging compromises sterility. The recall covers 57 boxes distributed worldwide.
Product
American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1817-2016·2016-06-01
Biomet Recalls Trauma and Sports Medicine Implants Due to Seal Defects
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Product
Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1789-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Delicot sponges because defective packaging may compromise sterility. The recall covers 343 boxes distributed worldwide.
Product
American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1783-2016·2016-06-01
American Surgical Delicot-J Sponges Recalled for Sterility Compromise
American Surgical Company is recalling 68 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were distributed worldwide.
Product
American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1721-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling 351 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Product
American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1812-2016·2016-06-01
Draeger D-Vapor Anesthesia Vaporizers Recalled for Anesthetic Agent Release
Draeger Medical is recalling D-Vapor and D-Vapor 3000 anesthesia vaporizers because they may release desflurane during filling, posing an eye irritation risk.
Product
Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1751-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling 33 boxes of Ultracot sponges because defective packaging may compromise sterility. The affected products were distributed worldwide.
Product
American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1799-2016·2016-06-01
American Surgical Cylindrical Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 11 boxes of cylindrical sponges because defective packaging may compromise sterility.
Product
American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1703-2016·2016-06-01
B. Braun Recalls WHIN Infusion Sets Due to Needle Protrusion Risk
B. Braun Medical is recalling WHIN Infusion Sets because the Huber needle tip may protrude from the needle guard, posing a safety risk to patients.
Product
WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1809-2016·2016-06-01
American Surgical Policot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Policot sponges because defective packaging compromises sterility. The products were distributed worldwide.
Product
American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1801-2016·2016-06-01
American Surgical Telfa Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling Telfa 1/2" x 1/2" sponges because defective packaging may compromise sterility. The recall covers 24 boxes distributed worldwide.
Product
American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 6 boxes distributed worldwide.
Product
American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1808-2016·2016-06-01
American Surgical Policot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Product
American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1781-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Compromise
American Surgical Company is recalling Delicot non-xray sponges because defective packaging compromises sterility. The recall covers 4 boxes distributed worldwide.
Product
American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1739-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 41 boxes of Ultracot sponges because defective packaging may compromise sterility.
Product
American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1768-2016·2016-06-01
American Surgical Ray-Cot Sponges Recalled for Sterility Compromise
American Surgical Company is recalling Ray-Cot sponges because defective packaging may have compromised sterility. The recall covers 28 boxes distributed worldwide.
Product
American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1828-2016·2016-06-01
Biomet Recalls Trauma and Sports Medicine Implants Due to Seal Defects
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Product
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1761-2016·2016-06-01
American Surgical Cotton Balls Recalled for Packaging Sterility Defects
American Surgical Company is recalling 3 boxes of 1-inch non-strung cotton balls due to packaging defects that compromise sterility.
Product
American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1770-2016·2016-06-01
American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 102 boxes of Ray-Cot 1" x 1" sponges because defective packaging compromises sterility.
Product
American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1757-2016·2016-06-01
American Surgical Cotton Balls Recalled for Packaging Sterility Defects
American Surgical Company is recalling 237 units of 1-inch strung cotton balls due to packaging defects that compromise sterility.
Product
American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 114 cases of Ultracot sponges because defective packaging compromises sterility.
Product
American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1820-2016·2016-06-01
Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility.
Product
Various trauma and sports medicine instruments and implants. Reamer.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·16V390000·2016-06-01
Pierce Emergency Vehicles Recalled for Improperly Soldered Pump Strainers
Pierce is recalling 2015-2016 emergency vehicles because pump intake strainers may be improperly soldered, risking pump damage and reduced firefighting effectiveness.
Product
PIERCE — PIERCE VELOCITY, ARROW XT, SABER, IMPEL
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1779-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 21 boxes of Delicot non-xray sponges because defective packaging may compromise sterility.
Product
American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1787-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling 409 boxes of Delicot sponges because defective packaging may compromise sterility.
Product
American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1826-2016·2016-06-01
Biomet Recalls Trauma and Spinal Implants Due to Sterile Seal Defects
Biomet is recalling various trauma, sports medicine, and spinal implants because insufficient seal strength may compromise sterility, potentially leading to infection.
Product
Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1811-2016·2016-06-01
American Surgical Company Recalls Neurosurgical Sponges Due to Packaging Defect
American Surgical Company is recalling 16 boxes of Mass Eye & Ear Finger Cot Nasal sponges because defective packaging compromises sterility.
Product
Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1784-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling 99 units of Delicot 4 mm x 50 mm sponges because defective packaging may compromise sterility.
Product
American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1752-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 27 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Product
American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1824-2016·2016-06-01
Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Product
Various trauma and sports medicine instruments and implants. Passer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1807-2016·2016-06-01
American Surgical Policot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.
Product
American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1819-2016·2016-06-01
Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.
Product
Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1742-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall affects worldwide distribution.
Product
American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1815-2016·2016-06-01
Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Product
Various trauma and sports medicine instruments and implants. guide, surgical, instrument
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1745-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 45 boxes of Ultracot sponges because defective packaging may compromise sterility.
Product
American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1791-2016·2016-06-01
American Surgical Delicot-J Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 37 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were distributed worldwide.
Product
American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1700-2016·2016-06-01
Ortho-Clinical Diagnostics Recalls VITROS Total Beta-hCG II Reagent Packs
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Total Beta-hCG II Reagent Packs and Calibrators because they may generate false positive results for hCG levels.
Product
1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1782-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 99 boxes of Delicot 4 mm x 50 mm sponges because defective packaging compromises sterility.
Product
American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1769-2016·2016-06-01
American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 449 boxes of Ray-Cot sponges because defective packaging may compromise sterility.
Product
American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2016·2016-06-01
American Surgical Americot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Americot White sponges because defective packaging may compromise sterility. The recall covers 35 boxes distributed worldwide.
Product
American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide

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