May 2017 recalls

771 recalls were announced in May 2017.

What the numbers show

Critical: 45
Severe: 174
High: 254
Moderate: 259
Low: 39

Of the 771 recalls this month scored against our rubric, 6% are Critical, 23% are Severe.

Which agencies issued them

201–300 of 771

SevereFDA (Drugs)·D-0725-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the compounded drugs.
Product
HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0784-2017·2017-05-24
Key Pharmacy Recalls Vitamin B Complex Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Vitamin B Complex injections because the firm cannot guarantee the products are sterile.
Product
VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0761-2017·2017-05-24
Key Pharmacy Recalls Cyanocobalamin Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Cyanocobalamin injections because the firm cannot ensure the products are sterile.
Product
CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0724-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.
Product
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0779-2017·2017-05-24
Key Pharmacy Recalls Sodium Carboxymethylcellulose Ophthalmic Solution Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Sodium Carboxymethylcellulose 0.5% Ophthalmic Solution because the firm cannot ensure the product is sterile.
Product
SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0739-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling a specific lot of TRI MIX injection due to a lack of assurance of sterility.
Product
TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0782-2017·2017-05-24
Key Pharmacy Recalls Testosterone Cypionate Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Cypionate injections because the firm cannot guarantee the products are sterile.
Product
TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0751-2017·2017-05-24
Key Pharmacy Recalls Compounded Sterile Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX injection due to a lack of assurance of sterility.
Product
TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0730-2017·2017-05-24
Key Pharmacy Recalls Papaverine/Phentolamine Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injection because the firm cannot assure the sterility of the product.
Product
PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0752-2017·2017-05-24
Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 5/30/0.5 injection vials because the firm cannot ensure the sterile compounded drugs are free from contamination.
Product
TRI MIX 5/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 5mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0774-2017·2017-05-24
Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 2% injections because the firm cannot guarantee the products are sterile.
Product
PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0710-2017·2017-05-24
Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 5-MTHF SDV 5mg/mL injections because the firm cannot assure the sterility of the compounded drugs.
Product
5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0717-2017·2017-05-24
Key Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 20 vials of Folic Acid 10mg/mL injection due to a lack of assurance of sterility.
Product
FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2097-2017·2017-05-24
Ion Beam Applications Recalls Two Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling two Proteus 235 proton therapy systems in Florida because the device may restart irradiation from the beginning after a pause instead of recalculating the dose.
Product
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Category
Medical Device
Distribution
1 state
SevereFDA (Drugs)·D-0707-2017·2017-05-24
Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 5-MTHF injections because the firm cannot assure the products are sterile.
Product
5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0746-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Product
TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0776-2017·2017-05-24
Key Pharmacy Recalls Pyridoxal-5-Phosphate Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Pyridoxal-5-Phosphate 100mg/mL injections due to a lack of assurance of sterility.
Product
PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0728-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.
Product
HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0712-2017·2017-05-24
Key Pharmacy Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Atropine Sulfate 0.5% Ophthalmic Solution because the firm cannot assure the sterility of the product.
Product
ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0713-2017·2017-05-24
Key Pharmacy Recalls CO-Q-10 Oil Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling CO-Q-10 Oil Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.
Product
CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0756-2017·2017-05-24
Key Pharmacy Recalls PGE1/Procaine Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injections because the firm cannot guarantee the products are sterile.
Product
PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0726-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.
Product
HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·17V338000·2017-05-24
Daimler Trucks Recalls 2013-2018 Freightliner S2G Chassis Trucks for Fire Risk
Daimler Trucks North America is recalling 2013-2018 Freightliner Custom Chassis S2G trucks because improperly routed hoses and wires may contact the exhaust pipe, increasing fire risk.
Product
FCCC — FCCC redundant S2G, S2G
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2114-2017·2017-05-24
Sorin Defibrillators Recalled for Undetectable Battery Depletion
Sorin Group is recalling 37 implanted defibrillators because battery depletion may be undetectable. Physicians are being notified to monitor affected patients.
Product
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac de
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0718-2017·2017-05-24
Key Pharmacy Recalls Folinic Acid Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Folinic Acid injections because the firm cannot guarantee the products are sterile.
Product
FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0765-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded Glutathione Inhalation Solution
Key Pharmacy and Compounding Center is recalling sterile compounded glutathione inhalation solution due to lack of assurance of sterility.
Product
GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0760-2017·2017-05-24
FDA Recalls Compounded Injection Due to Lack of Sterility Assurance
Key Pharmacy and Compounding Center is recalling CHOL/IN/ME(L)/B6 10ML MDV injection due to lack of assurance of sterility.
Product
CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0758-2017·2017-05-24
Key Pharmacy Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Alpha Lipoic Acid injections due to a lack of assurance of sterility. The affected product was distributed in the U.S., Australia, and Canada.
Product
ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0764-2017·2017-05-24
Key Pharmacy Recalls Iron Special Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Iron Special 5mL multiple-dose vials due to a lack of assurance of sterility.
Product
IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0729-2017·2017-05-24
Key Pharmacy Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injections because the firm cannot assure the sterility of the product.
Product
PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0789-2017·2017-05-24
Baxter Recalls Milrinone Lactate Injection Due to Sterility Concerns
Baxter Healthcare is recalling Milrinone Lactate in Dextrose Injection because customer complaints reported leaks, creating a lack of assurance of sterility.
Product
MILRINONE LACTATE IN DEXTROSE — MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0773-2017·2017-05-24
Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Procaine HCL 1% injections because the firm cannot assure the sterility of the compounded drugs.
Product
PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0755-2017·2017-05-24
Key Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Quad Mix 50/30/1/0.2 injection because the firm cannot assure the sterility of the product.
Product
QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0709-2017·2017-05-24
Key Pharmacy Recalls 5-MTHF Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL single-dose vials because the firm cannot assure the sterility of the product.
Product
5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0753-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.
Product
TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0769-2017·2017-05-24
Key Pharmacy Recalls Methyl-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 26 vials of Methyl-B12 injection due to a lack of assurance of sterility.
Product
METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0777-2017·2017-05-24
Key Pharmacy Recalls Pyridoxal-5-Phosphate Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Pyridoxal-5-Phosphate 50mg/mL injection vials due to a lack of assurance of sterility.
Product
PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0733-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded PGE1/CPZ Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ due to lack of assurance of sterility. The recall affects 2 vials distributed in the U.S., Australia, and Canada.
Product
PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0747-2017·2017-05-24
Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Product
TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0743-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 20/30/0.5 injection vials due to a lack of assurance of sterility.
Product
TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0716-2017·2017-05-24
FDA Recalls Key Pharmacy Compounded Ferric Gluconate Injection for Sterility Concerns
Key Pharmacy and Compounding Center is recalling a specific lot of compounded ferric gluconate injection due to a lack of assurance of sterility.
Product
FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0741-2017·2017-05-24
Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.
Product
TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-2220-2017·2017-05-24
Moondance Gluten-Free Mexican Wedding Cookies Recalled for Undeclared Pecans
Moondance Heavenly Desserts is recalling gluten-free Mexican Wedding Cookies because they contain undeclared pecans, a major allergen.
Product
Moondance desserts gluten free Mexican Wedding Cookie 8 oz (227g) UPC 7 36211 68076 1
Category
Food
Distribution
9 states
HighFDA (Food)·F-2227-2017·2017-05-24
Kemps Recalls Frozen Yogurt and Ice Cream Due to Plastic Contamination
Kemps, LLC is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Product
Kemps YO2 Frozen Yogurt Raspberry Cheesecake, One Pint, UPC 41483-04127
Category
Food
Distribution
20 states
HighFDA (Food)·F-2238-2017·2017-05-24
Whole Foods Organic Vanilla Yogurt Parfait Cups Recalled for Undeclared Almonds
Whole Foods is recalling single-serve Organic Vanilla Yogurt parfait cups with strawberries and granola because they contain undeclared almonds.
Product
Whole Foods single-serve Organic Vanilla Yogurt parfait cups with Strawberries and Granola, Various weights PLU 58260
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2094-2017·2017-05-24
Luminex ARIES System Recalled for Barcode Scanner Data Error
Luminex Corporation is recalling 15 ARIES Systems because a barcode scanner accessory may incorrectly populate patient sample IDs with previously scanned data.
Product
ARIES System and ARIES M1 System
Category
Medical Device
Distribution
0 states
HighNHTSA·17V336000·2017-05-24
Forest River Recalls Cardinal Trailers Due to Incorrect Weight Rating Labels
Forest River is recalling 2016-2018 Cardinal recreational trailers because the Federal Placard overstates the Gross Axle Weight Rating, which may lead to vehicle overloading.
Product
FOREST RIVER — FOREST RIVER CARDINAL
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·17V339000·2017-05-24
Keystone Springdale RVs Recalled for Incorrect Weight Rating Labels
Keystone is recalling 2012-2018 Springdale 303BH RVs because Federal Identification Tags overstate axle weight capacity, potentially leading to vehicle overload.
Product
KEYSTONE — KEYSTONE SPRINGDALE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-2222-2017·2017-05-24
Kemps Recalls Frozen Yogurt and Ice Cream Due to Plastic Contamination
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Product
Kemps YO2 Frozen Yogurt Mudslide, One Pint, UPC 41483-04121
Category
Food
Distribution
20 states
HighNHTSA·17V337000·2017-05-24
MCI Recalls 2011-2012 Coaches Due to Exhaust Pipe Fire Risk
Motor Coach Industries is recalling 2011-2012 MCI D4000, D4005, D4500, and D4505 coaches because an incorrectly installed exhaust bellow pipe may bend and fail, increasing the risk of fire.
Product
MCI — MCI D4000, D4500, D4505, D4005
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·17T011000·2017-05-24
Sumitomo Recalls Dunlop Sportmax Q3+ Motorcycle Tires for Porosity Defect
Sumitomo is recalling specific Dunlop Sportmax Q3+ motorcycle tires due to air pockets in the shoulder that may affect handling and increase crash risk.
Product
TIRES recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0738-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded Drug Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 10/30/1 injection due to a lack of assurance of sterility.
Product
TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2017·2017-05-24
Vortran Automatic Resuscitator Recalled Due to Reverse-Threaded Oxygen Connector
Vortran is recalling 14 cases of VARPlus Automatic Resuscitators because the oxygen tubing connector was assembled in reverse, preventing it from being screwed on.
Product
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
Category
Medical Device
Distribution
3 states
HighFDA (Drugs)·D-0772-2017·2017-05-24
Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 1% injections because the firm cannot ensure the products are sterile.
Product
PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2100-2017·2017-05-24
Mobius3D Software Recalled for Dose Calculation Defect in Radiation Therapy
Mobius Medical Systems is recalling Mobius3D software versions 1.5.0 and 1.5.2 due to a code defect that may cause dose calculation discrepancies in radiation therapy.
Product
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2095-2017·2017-05-24
BioMerieux Recalls ETEST ETP32 Ertapenem Strips Due to False Results
BioMerieux SA is recalling ETEST ETP32 (Ertapenem) strips because they may produce false susceptible results, potentially leading to incorrect antibiotic treatment.
Product
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2155-2017·2017-05-24
Raley's Muesli Almond Crunch Cereal Recalled for Missing Coconut Allergen Labeling
Raley's is recalling Muesli Almond Crunch Cereal because an internal review found coconut was not listed in the allergen declaration. The product was distributed in California and Nevada.
Product
RALEY'S MUESLI ALMOND CRUNCH MUESLI CEREAL; 12 oz. box - foil bag inside paper box. UPC: 46567-02263; Product Distributed by Raley's, West Sacramento, CA; Product of Switzerland
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2110-2017·2017-05-24
Molnlycke Recalls Brennen Skin Graft Mesher Due to Sterilization Failure
Molnlycke Health Care is recalling 956 units of the Brennen Skin Graft Mesher because of a sterilization validation failure. The instruments were distributed domestically and internationally.
Product
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2093-2017·2017-05-24
Spacelabs Arkon Anesthesia Delivery System Canister Carrier Recall
Del Mar Reynolds Medical is recalling 62 Spacelabs Arkon Anesthesia Delivery System components because the canister carrier can break, causing a breathing circuit leak and potential patient hypoventilation.
Product
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, p
Category
Medical Device
Distribution
6 states
HighFDA (Drugs)·D-0722-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the products.
Product
HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2087-2017·2017-05-24
Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage
Aesculap Implant Systems LLC is recalling 608 ELAN 4 diamond burrs because particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.
Product
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4 1-RING
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2231-2017·2017-05-24
Kemps Sweet Me Creamery Ice Cream Recalled for Plastic Contamination
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Product
Kemps Sweet Me Creamery Creamy Dark Chocolate Mint, One Pint, UPC 41483-04143
Category
Food
Distribution
20 states
HighFDA (Drugs)·D-0757-2017·2017-05-24
Key Pharmacy Recalls PGE1/Procaine Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injection because the firm cannot ensure the sterile compounded drugs are free from contamination.
Product
PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2088-2017·2017-05-24
Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage Risk
Aesculap Implant Systems LLC is recalling ELAN 4 2-Ring Diamond Burrs because diamond particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.
Product
GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; Product Usage: The ELAN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2103-2017·2017-05-24
Medline 16 mm Distraction Pin Recalled Due to Sterile Seal Integrity
Medline Industries is recalling 198 packs of 16 mm Distraction Pins because the sterile packaging seal may be compromised, risking loss of sterility.
Product
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2219-2017·2017-05-24
Moondance Gluten-Free Chocolate Chip Cookie Bars Recalled for Undeclared Milk
Moondance Heavenly Desserts is recalling gluten-free Chocolate Chip Cookie Bars because they contain undeclared milk. The product was distributed to nine states.
Product
Moondance desserts gluten free Chocolate Chip Cookie Bar 12 oz (340g) UPC 36211 68096 9
Category
Food
Distribution
9 states
HighFDA (Devices)·Z-2106-2017·2017-05-24
Medline 14 mm Distraction Pin Recalled for Potential Sterility Loss
Medline Industries is recalling 14 mm Distraction Pins due to potential sterile packaging seal failures that could compromise device sterility.
Product
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1925-2017·2017-05-24
Magellan LeadCare Blood Analyzer Recall for Falsely Low Lead Results
Magellan Diagnostics is recalling LeadCare Ultra Blood Analyzers because they may generate falsely low lead concentrations when used with specific Becton Dickinson collection tubes.
Product
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2061-2017·2017-05-24
Philips V60 Ventilators Recalled for Connector Pin Displacement
Respironics is recalling 30,516 Philips V60 Ventilators because low-frequency vibrations can displace connector pins, causing momentary data transmission failures.
Product
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1898-2017·2017-05-24
ReFlow Medical Recalls Wingman 35 Crossing Catheters Due to Tip Detachment Risk
ReFlow Medical is recalling Wingman 35 Crossing Catheters because they may be prone to tip detachment. The recall affects 2,794 units distributed in the US and internationally.
Product
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2039-2017·2017-05-24
Abbott NC Tenku RX Balloon Catheter Recall for Sheath Removal Issues
Abbott Vascular is recalling NC Tenku RX PTCA Balloon Catheters because the protective sheath may be difficult to remove, potentially affecting balloon inflation or deflation.
Product
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-2221-2017·2017-05-24
Oberlander Gluten Free Chocolate Kokosh Cake Recalled for Undeclared Almond
Oberlander Baking Co is recalling Gluten Free Brand Chocolate Kokosh Cake because it may contain undeclared almond.
Product
Oberlander Bakery Gluten Free Brand Chocolate Kokosh Cake Net Wt. 16 oz. Manufactured by: Orthodox Baking Co. Inc. Belleville, NJ 07109, UPC 43711 18093 7
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-1926-2017·2017-05-24
Magellan LeadCare Ultra Blood Lead Test Kits Recalled for Inaccurate Results
Magellan Diagnostics is recalling LeadCare Ultra Blood Lead Test Kits because they may generate falsely low lead concentrations when used with specific Becton Dickinson EDTA Vacutainer tubes.
Product
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2017·2017-05-24
Medline Recalls 10 mm Distraction Pins Due to Sterile Seal Concerns
Medline Industries is recalling 10 mm Distraction Pins because the sterile packaging seal may be compromised, potentially causing the device to lose sterility.
Product
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fix
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0785-2017·2017-05-24
Key Pharmacy Recalls Vitamin D3 Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Vitamin D3 in Olive Oil SDV 100,000U/mL Injection due to a lack of assurance of sterility.
Product
VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-2237-2017·2017-05-24
Full Tilt Ice Cream Recalls Vegan Fudge Brownie Swirl for Undeclared Wheat
Full Tilt Ice Cream is recalling 2,862 pints of Fudge Brownie Swirl Vegan ice cream because the product contains flour but does not declare wheat as an allergen.
Product
Label reads in part "***Full Tilt Ice Cream Fudge Brownie Swirl Vegan***one pint***Ingredients: Coconut Milk (coconut milk, water, citric acid), organic evaporated cane juice, bownie bits (flour, sugar, cocoa powder, non-aluminum baking powder, salt, vanilla extract, coconut oil
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0781-2017·2017-05-24
Key Pharmacy Recalls SOD Phenylbutyrate Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 91 vials of SOD Phenylbutyrate injections due to a lack of assurance of sterility.
Product
SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-2230-2017·2017-05-24
Kemps Recalls Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt for Plastic
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Product
Kemps Sweet Me Creamery Vanilla Bean, One Pint, UPC 41483-04142
Category
Food
Distribution
20 states
HighCPSC·17158·2017-05-24
Leggett & Platt Recalls Office Chairs Due to Fall Hazard
Leggett & Platt is recalling about 47,900 office chairs in the U.S. because seat slider bolts can disconnect, causing the seat to detach and posing a fall hazard.
Product
Office chairs
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0723-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Inhalation Solution Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Hydroxo-B12 inhalation solution because the firm cannot assure the sterility of the product.
Product
HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0734-2017·2017-05-24
Key Pharmacy Recalls Compounded PGE1/PAP Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of compounded PGE1/PAP injection because the firm cannot assure the sterility of the product.
Product
PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2072-2017·2017-05-24
Eden Spine GIZA Vertebral Body Replacement Recalled Due to Locking Screw Failure
Eden Spine Europe SA is recalling GIZA Vertebral Body Replacement devices because locking screws may unscrew completely, causing the implants to disassemble.
Product
GIZA Vertebral Body Replacement
Category
Medical Device
Distribution
41 states
HighFDA (Food)·F-2233-2017·2017-05-24
Kemps Sweet Me Creamery Ice Cream Recalled for Plastic Contamination
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Product
Kemps Sweet Me Creamery Strawberry Rhubarb Cobbler, One Pint, UPC 41483-04145
Category
Food
Distribution
20 states
HighFDA (Drugs)·D-0708-2017·2017-05-24
Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL multiple-dose vials due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.
Product
5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-2223-2017·2017-05-24
Kemps Recalls Frozen Yogurt and Ice Cream for Plastic Contamination
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Product
Kemps YO2 Frozen Yogurt Cold Brewed Coffee, One Pint, UPC 41483-04122
Category
Food
Distribution
20 states
HighFDA (Devices)·Z-2091-2017·2017-05-24
Vortran VARPlus Automatic Resuscitator Recalled Due to Connector Assembly Error
Vortran is recalling 35 cases of VARPlus Automatic Resuscitators because a connector was assembled in the reverse direction, preventing it from screwing onto the oxygen tubing.
Product
VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-2232-2017·2017-05-24
Kemps Recalls Sweet Me Creamery Ice Cream Due to Plastic Contamination
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Product
Kemps Sweet Me Creamery Chocolate Peanut Butter Pretzel, One Pint, UPC 41483-04144
Category
Food
Distribution
20 states
HighFDA (Food)·F-2226-2017·2017-05-24
Kemps Recalls Frozen Yogurt and Ice Cream Due to Plastic Contamination
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Product
Kemps YO2 Frozen Yogurt Chocolate Peanut Butter Fudge, One Pint, UPC 41483-04126
Category
Food
Distribution
20 states
HighFDA (Devices)·Z-2077-2017·2017-05-24
Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly
Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems due to a software anomaly that may cause sample ID misassociation, potentially leading to misdiagnosis.
Product
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-2098-2017·2017-05-24
Bausch & Lomb Recalls SoftPort Easy-Load Lens Delivery System
Bausch & Lomb is recalling specific lots of the SoftPort Easy-Load Lens Delivery System due to reports of kinked haptics during lens delivery.
Product
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic pull
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2202-2017·2017-05-24
Wegman's O'Brien Hash Browns Recalled for Foreign Material Contamination
McCain Foods USA is recalling Wegman's O'Brien Hash Browns because the product may contain hard plastic or rubber pieces from golf balls.
Product
Wegman's O'Brien Hash Browns, frozen packages, net wt. 28 oz. UPC 07789036523.
Category
Food
Distribution
6 states
HighFDA (Food)·F-2153-2017·2017-05-24
Raley's Muesli Cereal Recalled for Missing Coconut Allergen Labeling
Raley's is recalling Muesli Chocolate Curlcrunch Cereal because an internal review found coconut was not listed in the allergen declaration.
Product
RALEY'S MUESLI CHOCOLATE CURLCRUNCH CEREAL; 12 oz. box - foil bag inside paper box. UPC: 46567-02266;Product Distributed by Raley's, West Sacramento, CA;Product of Switzerland
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2089-2017·2017-05-24
Aesculap Hi-Line XS Diamond Burrs Recalled for Particulate Breakage Risk
Aesculap Implant Systems LLC is recalling 608 Hi-Line XS Diamond Burrs because diamond particulates may break off and fall into the surgical site, potentially causing foreign body reactions or soft tissue damage.
Product
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2111-2017·2017-05-24
Zimmer Werber Countersink Instruments Recalled Due to Material Defect
Zimmer GmbH is recalling Werber Countersink instruments because raw material defects caused device damage.
Product
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortic
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-2154-2017·2017-05-24
Raley's Muesli Red Berry Crunch Cereal Recalled for Missing Coconut Allergen
Raley's is recalling Muesli Red Berry Crunch Cereal because an internal review found coconut was not listed in the allergen declaration.
Product
RALEY'S MUESLI RED BERRY CRUNCH CEREAL; 12 oz. box - foil bag inside paper box. UPC: 46567-02264;product Distributed by Raley's, West Sacramento, CA;Product of Switzerland
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2074-2017·2017-05-24
Beckman Coulter Access BR Monitor Recalled for Potential Result Bias
Beckman Coulter is recalling Access BR Monitor units because French quality controls indicated potential result biases for cancer patients.
Product
Access BR Monitor, Part No. 387620
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-2218-2017·2017-05-24
Whole Foods Recalls Holiday Cookies Due to Undeclared Wheat
Whole Foods Market is recalling 216 decorated holiday cookies sold in the Bay Area because they contain undeclared wheat.
Product
Decorated (iced) holiday cookies sold in the shape of eggs. These cookies were sold in the self service cookie displays. Individual cookies are 1.3 oz.. each. Cookie labels identify the cookies as: Sugared Purple Egg Cookies: Sugar Pink Bunny Cookie; Sugared Yellow Chick Coo
Category
Food
Distribution
0 states
HighCPSC·17747·2017-05-24
Rejuvenation Recalls Articulating Wall Sconces Due to Electrical Shock Hazard
Williams-Sonoma is recalling Rejuvenation Cypress and Imbrie wall sconces because the articulating joint can pinch wires, creating a shock risk.
Product
Articulating wall sconces
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2229-2017·2017-05-24
Kemps Recalls Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt for Plastic
Kemps, LLC is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Product
Kemps Sweet Me Creamery Salted Caramel Brownie, One Pint, UPC 41483-04141
Category
Food
Distribution
20 states
ModerateFDA (Devices)·Z-2101-2017·2017-05-24
Medical Action Industries Recalls Sterile Operating Room Towels Due to Lint
Medical Action Industries is recalling sterile operating room towels because lint is present on the product.
Product
White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
Category
Medical Device
Distribution
3 states

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