July 2016 recalls

921 recalls were announced in July 2016.

What the numbers show

Critical: 82
Severe: 408
High: 239
Moderate: 175
Low: 17

Of the 921 recalls this month scored against our rubric, 9% are Critical, 44% are Severe.

Which agencies issued them

401–500 of 921

SevereFDA (Drugs)·D-1285-2016·2016-07-20
Pharmakon Recalls Fentanyl Citrate Cadd Cassettes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 10mcg/mL cadd cassettes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.
Product
Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1186-2106·2016-07-20
Medaus Recalls GABA 50mg/mL Vials Due to Sterility Concerns
Medaus, Inc. is recalling GABA 50mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1238-2016·2016-07-20
Medaus Recalls Selenium Vials Due to Lack of Sterility Assurance
Medaus, Inc. is recalling specific lots of Selenium 200mcg/mL vials because the company cannot ensure the product is sterile.
Product
SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1287-2016·2016-07-20
Pharmakon Recalls Ketamine Syringes Due to Sterility Assurance Concerns
Pharmakon Pharmaceuticals is recalling 200 units of compounded Ketamine 50mg/mL syringes due to a lack of assurance of sterility.
Product
Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0603-78
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1222-2016·2016-07-20
Medaus Recalls B-Complex Premix Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of M.I.C B-Complex Premix vials because the company cannot ensure the product is sterile.
Product
M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1251-2016·2016-07-20
Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Zinc Sulfate 10mg/mL vials because the company cannot guarantee the product is sterile.
Product
ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1198-2016·2016-07-20
Medaus Recalls L-Glutathione Vials Due to Sterility Concerns
Medaus, Inc. is recalling L-Glutathione 100mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1248-2016·2016-07-20
Medaus Recalls TMG 100 mg/mL Vials Due to Sterility Concerns
Medaus, Inc. is recalling TMG 100 mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1193-2016·2016-07-20
Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific vials of Hydroxy B12 injection due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.
Product
HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1649-2016·2016-07-20
Dr. Praeger's Recalls Frozen Veggie Burgers for Listeria Risk
Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Burgers because they may be contaminated with Listeria monocytogenes.
Product
Dr. Praeger's California Veggie Burger (Vegan), 4 oz., 10 lbs (4.54 kg), Best if used by: May-16-2018, UPC (01)0 0080868 97010 3, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1202-2016·2016-07-20
Medaus Recalls Lipo #4 Vials Due to Sterility Concerns
Medaus, Inc. is recalling Lipo #4 vials because the FDA cannot assure the product is sterile. The recall affects vials distributed in the U.S., Japan, and New Zealand.
Product
LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML; 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1233-2016·2016-07-20
Medaus Recalls Proline 100mg/mL Vials Due to Sterility Concerns
Medaus, Inc. is recalling Proline 100mg/mL vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1284-2016·2016-07-20
Pharmakon Recalls Hydromorphone Cadd Cassettes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 10 units of Hydromorphone HCI cadd cassettes because the company cannot guarantee the products are sterile.
Product
Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1235-2016·2016-07-20
Medaus Recalls Pyridoxine HCL Vials Due to Sterility Concerns
Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL vials because the company cannot assure the sterility of the product.
Product
PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1270-2016·2016-07-20
Pharmakon Recalls Fentanyl and Bupivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine due to a lack of assurance of sterility.
Product
Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1224-2016·2016-07-20
Medaus Recalls M.I.C 25/50/50 Vials Due to Sterility Concerns
Medaus, Inc. is recalling M.I.C 25/50/50 vials because the company cannot guarantee the product is sterile.
Product
M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1283-2016·2016-07-20
Pharmakon Recalls Morphine Sulfate Cadd Cassettes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 units of Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassettes due to a lack of assurance of sterility.
Product
Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1264-2016·2016-07-20
Pharmakon Recalls Propofol Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 2,580 units of compounded Propofol 1% injection because the company cannot ensure the product is sterile.
Product
Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1200-2016·2016-07-20
Medaus Recalls Lidocaine 2% Vials Due to Sterility Concerns
Medaus, Inc. is recalling Lidocaine 2% (PF) in NaCl 10mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Product
LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1189-2016·2016-07-20
Medaus Recalls Hydrogen Peroxide Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Hydrogen Peroxide 3% vials because the company cannot ensure the product is sterile.
Product
HYDROGEN PEROXIDE 3% (PF), 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1331-2016·2016-07-20
Pharmakon Recalls Ropivacaine HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 129 bags of Ropivacaine HCI 0.2% due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Product
Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1338-2016·2016-07-20
Pharmakon Recalls Midazolam HCI Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 2,000 units of compounded Midazolam HCI syringes due to a lack of assurance of sterility.
Product
Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1207-2016·2016-07-20
Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the company cannot ensure the product is sterile.
Product
LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1310-2016·2016-07-20
Pharmakon Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 100 units of compounded Fentanyl and Bupivacaine syringes due to a lack of assurance of sterility.
Product
Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1220-2016·2016-07-20
Medaus Recalls M.I.C. 25/50/50 Vials Due to Sterility Concerns
Medaus, Inc. is recalling M.I.C. 25/50/50 (PF) vials because the company cannot ensure the product is sterile. The recall covers multiple lots distributed in the U.S., Japan, and New Zealand.
Product
M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1205-2016·2016-07-20
Medaus Recalls Lipo-Boost Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Lipo-Boost vials because the company cannot guarantee the product's sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1271-2016·2016-07-20
Pharmakon Recalls Potassium Chloride IV Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Potassium Chloride IV bags because they may not be sterile. The recall covers products distributed nationwide and to specific VA/DOD facilities.
Product
Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1648-2016·2016-07-20
Dr. Praeger's Recalls Frozen Veggie Burgers Due to Listeria Risk
Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Burgers because they may be contaminated with Listeria monocytogenes.
Product
Dr. Praeger's California Veggie Burger (Vegan), 4 oz., 10 lbs (4.54 kg), Best if used by: May-16-2018, UPC (01)0 0080868 01010 6, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1300-2016·2016-07-20
Pharmakon Recalls Midazolam HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 45 bags of compounded Midazolam HCI due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1324-2016·2016-07-20
Pharmakon Recalls Phenylephrine Syringes Due to Sterility Assurance Concerns
Pharmakon Pharmaceuticals is recalling Phenylephrine HCI syringes because the company cannot ensure the products are sterile.
Product
Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1218-2016·2016-07-20
Medaus Recalls Methyl B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Methyl B12 5mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Product
METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1274-2016·2016-07-20
Pharmakon Recalls Methohexital Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 225 syringes of Methohexital (Brevital Sodium) 10 mg/mL because the company cannot ensure the product is sterile.
Product
Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1325-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 90 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2146-2016·2016-07-20
Hardy Diagnostics Recalls QuickSlide MGS-80 Gram Stainers Due to Discrepant Results
Hardy Diagnostics is recalling 25 QuickSlide MGS-80 and GramPRO-80 automated Gram stainers because they may produce discrepant culture and Gram stain results, potentially leading to misdiagnosis or improper patient treatment.
Product
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Category
Medical Device
Distribution
13 states
SevereFDA (Drugs)·D-1295-2016·2016-07-20
Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin 30 Units in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1234-2016·2016-07-20
Medaus Recalls Pyridoxal and Thiamine Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific vials of Pyridoxal/Thiamine/Lidocaine due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.
Product
PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1269-2016·2016-07-20
Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 95 bags of compounded Fentanyl and Ropivacaine due to a lack of assurance of sterility.
Product
Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0148-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1197-2016·2016-07-20
Medaus Recalls L-Carnitine Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling L-Carnitine 500mg/mL vials because the company cannot assure the product's sterility. The recall covers products distributed in the U.S., Japan, and New Zealand.
Product
L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1645-2016·2016-07-20
Dr. Praeger's Recalls Frozen Veggie Burger Sliders Due to Listeria Risk
Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Burger Sliders because they may be contaminated with Listeria monocytogenes.
Product
Dr. Praeger's California Veggie Burger Sliders (Vegan), 1.5 oz., 10 lbs. (4.54 kg), Best if used by: May-17-2018, UPC (01) 0 0080868 01015, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1178-2016·2016-07-20
Medaus Recalls Dexpantenol Vials Due to Sterility Concerns
Medaus, Inc. is recalling Dexpantenol 250mg/mL vials because the company cannot ensure the product is sterile.
Product
DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1227-2016·2016-07-20
Medaus Recalls Molybdenum Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Molybdenum 250mcg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution in the U.S., Japan, and New Zealand.
Product
MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1241-2016·2016-07-20
Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
Medaus, Inc. is recalling Testosterone Cypionate vials because the company cannot guarantee the product is sterile.
Product
TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1292-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 units of compounded Hydromorphone HCI syringes due to a lack of assurance of sterility.
Product
Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1221-2016·2016-07-20
Medaus Recalls M.I.C./B-Complex Vials Due to Sterility Concerns
Medaus, Inc. is recalling M.I.C./B-Complex (PF) vials because the company cannot assure the sterility of the product. The recall affects 3,000 mL in vials distributed in the U.S., Japan, and New Zealand.
Product
M.I.C./B-COMPLEX (PF) B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1323-2016·2016-07-20
Pharmakon Recalls Ketamine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 175 units of compounded Ketamine 20 mg/mL due to a lack of assurance of sterility.
Product
Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0925-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1293-2016·2016-07-20
Pharmakon Recalls Hydromorphone PCA Vials Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 100 vials of Hydromorphone HCI 0.2mg/ml PCA solution due to a lack of assurance of sterility.
Product
HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1201-2016·2016-07-20
Medaus Recalls Lipo with Lidocaine Vials Due to Sterility Concerns
Medaus, Inc. is recalling Lipo with Lidocaine #3 vials because the company cannot ensure the product is sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.
Product
LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1305-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 560 vials of Hydromorphone HCl 0.4mg/mL in 30 mL syringes due to a lack of assurance of sterility.
Product
HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1252-2016·2016-07-20
Medaus Recalls Arginine Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling specific lots of Arginine 100mg/mL vials because the company cannot assure the product is sterile.
Product
ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1289-2016·2016-07-20
Pharmakon Recalls Cefazolin 2GM Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 5% Dextrose 50 mL due to a lack of assurance of sterility. The recall affects 1,450 units distributed nationwide.
Product
Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1301-2016·2016-07-20
Pharmakon Recalls Epinephrine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Epinephrine HCI syringes because the company cannot ensure the products are sterile.
Product
Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1313-2016·2016-07-20
Pharmakon Recalls Atropine Sulfate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 400 units of Atropine Sulfate syringes because the company cannot ensure the products are sterile.
Product
Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1330-2016·2016-07-20
Pharmakon Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 800 syringes of Ephedrine Sulfate 5 mg/ml due to a lack of assurance of sterility.
Product
Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1173-2016·2016-07-20
Medaus Recalls B-Complex 50 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of B-Complex 50 vials because the company cannot ensure the product is sterile.
Product
B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1192-2016·2016-07-20
Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Hydroxy B12 1000mcg/mL vials because the company cannot ensure the product is sterile.
Product
HYDROXY B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1676-2016·2016-07-20
Kroger Sunflower Kernels Recalled for Listeria Contamination Risk
The Kroger Co is recalling Roasted & Salted Sunflower Kernels because the supplier notified them of a potential Listeria monocytogenes contamination.
Product
Kroger SALAD TOPPERS Roasted & Salted Sunflower Kernels NET WT 3.5 OZ (99G) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 02127 4
Category
Food
Distribution
28 states
SevereFDA (Food)·F-1633-2016·2016-07-20
Dr. Praeger's Recalls Frozen Veggie Burgers for Listeria Risk
Dr. Praeger's is voluntarily recalling Aldi California/Black Bean Veggie Burgers because they may be contaminated with Listeria monocytogenes.
Product
Aldi California/Black Bean Veggie Burgers, Net 15.0 lbs, 24 x 10 oz (284g)/box, Sale By: May -09-2018
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1253-2016·2016-07-20
Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Zinc Sulfate 1mg/mL vials because the company cannot ensure the product is sterile.
Product
ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1217-2016·2016-07-20
Medaus Recalls Methyl B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific vials of Methyl B12 injection due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.
Product
METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1321-2016·2016-07-20
Pharmakon Recalls Bupivacaine HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Bupivacaine HCI 0.125% bags due to a lack of assurance of sterility. The recall affects 55 units distributed nationwide.
Product
Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0909-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1272-2016·2016-07-20
Pharmakon Recalls Norepinephrine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 24 bags of compounded Norepinephrine 16 mg in 0.9% sodium chloride due to a lack of assurance of sterility.
Product
Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1185-2016·2016-07-20
Medaus Recalls Folic Acid Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Folic Acid 10mg/mL vials because the company cannot ensure the product is sterile.
Product
FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1187-2016·2016-07-20
Medaus Recalls Germanium Seso 100mg/mL Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Germanium Seso 100mg/mL vials because the FDA determined there is a lack of assurance of sterility.
Product
GERMANIUM SESO 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1215-2016·2016-07-20
Medaus Recalls Methyl B12 and Pyridoxine Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Methyl B12 and Pyridoxine vials because the company cannot guarantee the product is sterile.
Product
METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1340-2016·2016-07-20
Pharmakon Recalls Vecuronium Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 275 vials of compounded Vecuronium 1mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1339-2016·2016-07-20
Pharmakon Recalls Rocuronium Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 1,200 units of Rocuronium 10mg/ml syringes because the company cannot ensure the product is sterile.
Product
Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0971-72
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1344-2016·2016-07-20
Pharmakon Recalls Sufentanil and Bupivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 595 bags of compounded Sufentanil and Bupivacaine due to a lack of assurance of sterility.
Product
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1337-2016·2016-07-20
Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 1,500 syringes of Fentanyl Citrate 50 mcg/mL because the company cannot ensure the products are sterile.
Product
Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1180-2016·2016-07-20
Medaus Recalls DMPS 50mg/mL Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling DMPS 50mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Product
DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2149-2016·2016-07-20
Varian Optical Surface Monitoring System Recall for Unintended Couch Parameter Changes
Varian Medical Systems is recalling Optical Surface Monitoring Systems (OSMS) used with TrueBeam EDGE because unintended changes to couch rotation parameters can occur during patient set-up.
Product
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2147-2016·2016-07-20
Sorin Recalls Aortic Arch Cannulae Due to Incorrect Tip Angle
Sorin Group USA is recalling Aortic Arch Cannulae because the distal tip angle is 15-20 degrees instead of the specified 45 degrees.
Product
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1667-2016·2016-07-20
Silva International Recalls Zesty Nacho Spice Blend for Undeclared Gluten
Silva International is recalling 10,000 lbs of Zesty Nacho Spice Blend because samples tested positive for gluten, possibly from wheat, which was not disclosed on the label.
Product
Zesty Nacho Spice Blend (containing dehydrated chipotle powder) from Silva International packaged in a 50 lb. poly-lined cardboard box.
Category
Food
Distribution
8 states
HighNHTSA·16E063000·2016-07-20
Eaton Recalls Spool Valve Motors Due to Potential Shaft Breakage
Eaton is recalling specific Spool Valve Motors because the motor shaft may break, potentially causing unexpected movement of hydraulic booms or winches and increasing injury risk.
Product
EQUIPMENT:MECHANICAL:WINCH recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2180-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2183-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1250-2016·2016-07-20
Medaus Recalls Zinc Chloride Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Zinc Chloride vials because the company cannot guarantee the product is sterile.
Product
ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2166-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of internal sutures, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2016·2016-07-20
Novarad NovaPACS Diagnostic Viewer Recall for Image Orientation Flipping
Novarad Corporation is recalling NovaPACS Diagnostic Viewer software versions 7.4, 7.5, 7.6, and 8.0 because images may flip during streaming, potentially displaying incorrect orientation markers.
Product
NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1678-2016·2016-07-20
Baked in the Sun Recalls Smore's Muffins for Undeclared Peanut Residual
Baked in the Sun Corporation is recalling Smore's Muffins because they may contain undeclared peanut residual. The product is a wholesale food service item distributed in California and Nevada.
Product
Baked in the Sun 4 Pack Smore's Muffin, Wholesale item (food service), not labeled for individual retail sale. 4 pcs/carton
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2179-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2200-2016·2016-07-20
Medtronic Temporary Pacing Lead System Recalled for Design Non-Compliance
Medtronic is recalling Temporary Pacing Lead Systems because they do not meet design standards preventing connection to hazardous voltage.
Product
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2205-2016·2016-07-20
Stryker Recalls Specific Lots of Round Fluted Burs Due to Corrosion
Stryker is voluntarily recalling specific lots of 6.0mm Round Fluted Burs due to potential tarnishing or corrosion that could cause inflammation requiring surgery.
Product
6.0mm Round Fluted Bur, Super Long
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2185-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2165-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2150-2016·2016-07-20
Varian AlignRT Plus Optical Surface Monitoring System Recall for Parameter Errors
Varian Medical Systems is recalling AlignRT Plus systems because unintended changes to couch rotation parameters can occur during patient set-up.
Product
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2171-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2164-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2177-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may cause the coils to stretch.
Product
Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2173-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of the internal sutures.
Product
Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1680-2016·2016-07-20
Magic Seasoning Blends Recalls Outback Steakhouse Batter for Peanut Allergen
Magic Seasoning Blends is recalling specific lots of Outback Steakhouse OSI Mama's Batter due to potential peanut protein contamination.
Product
OUTBACK STEAKHOUSE OSI Mama's Batter, Qty 40lbs, NET WEIGHT 40 lbs, MFG FOR: OSI, TAMPA, FL 33609
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1679-2016·2016-07-20
Magic Seasoning Blends Recalls Onion Breader for Potential Peanut Presence
Magic Seasoning Blends is recalling 9,900 lbs of Onion Breader due to potential peanut protein in the milled flour used in the blend.
Product
ONION BREADER, NET WEIGHT 25 lbs, MFG FOR: LEE ROY SELMONS, TAMPA, FL 33609
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1590-2016·2016-07-20
Silva International Recalls Dehydrated Chipotle Powder for Undeclared Gluten
Silva International is recalling 2,908 lbs of dehydrated chipotle powder because samples tested positive for gluten, possibly from wheat, which was not disclosed on the label.
Product
Dehydrated chipotle powder from Silva International packaged in a 50 lb. poly-lined cardboard box.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-2163-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2172-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2175-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2170-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2211-2016·2016-07-20
Devicor Mammotome Biopsy System Recalled for Incorrect Needle Packaging
Devicor Medical Products is recalling Mammotome Revolve biopsy systems because 10-gauge needles were shipped in 8-gauge packages.
Product
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number…
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2186-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2174-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide

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