December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical: 72
Severe: 319
High: 264
Moderate: 310
Low: 63

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 31% are Severe.

Which agencies issued them

901–1000 of 1028

CriticalFDA (Food)·F-0550-2015·2014-12-03
MaraNatha and Whole Foods Almond Butter Recalled for Salmonella Risk
nSpired Natural Foods is recalling specific almond butter products due to potential Salmonella contamination. The products were distributed in the US, Canada, and other countries.
Product
MaraNatha Roasted Creamy Almond Butter, 16 oz., UPC 51651060325; MaraNatha Roasted Creamy Almond Butter, 26 oz., UPC 51651092897; Whole Foods 365 Creamy Almond Butter, 16 oz., UPC 99482406578.
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-0584-2015·2014-12-03
Kerry Brown Butter Recalled Due to Salmonella Contamination
Kerry Foods is recalling specific lots of Brown Butter because an ingredient tested positive for Salmonella. The product was distributed in six US states and Canada.
Product
Item Number 30590439.01, Kerry, Brown Butter 30590439.01, Net WT 50 lb (22.68 KG), Lot Number: 0416424102
Category
Food
Distribution
6 states
CriticalFDA (Food)·F-0543-2015·2014-12-03
Trader Joe's Raw Crunchy Almond Butter Recalled for Salmonella Risk
nSpired Natural Foods is recalling Trader Joe's Raw Crunchy Almond Butter Unsalted due to potential Salmonella contamination. The product was distributed in the U.S., Canada, and other countries.
Product
Trader Joe's Raw Crunchy Almond Butter Unsalted, 16 oz., UPC 919890.
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-0555-2015·2014-12-03
MaraNatha Almond Butter Recalled for Potential Salmonella Contamination
nSpired Natural Foods is recalling MaraNatha Roasted Creamy Almond Butter No Sodium due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
Product
MaraNatha Roasted Creamy Almond Butter No Sodium, 737 grams, UPC 51651092869
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-0552-2015·2014-12-03
MaraNatha and Kroger Almond Butter Recalled for Salmonella Risk
nSpired Natural Foods is recalling specific MaraNatha and Kroger almond butter products due to potential Salmonella contamination.
Product
MaraNatha No Stir Creamy Almond Butter, 12 oz., UPC 51651093682; MaraNatha No Stir Creamy Almond Butter, 340 grams, UPC 51651093453; Kroger No Stir Creamy Almond Butter, 12 oz., UPC 11110791214;
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-0590-2015·2014-12-03
Whole Foods Market Plain Streusel Coffeecake Recalled for Undeclared Pecans
Whole Foods Market is recalling Plain Streusel Coffeecake (no nuts) because it contains undeclared pecans, a major food allergen.
Product
Whole Foods Market Plain Streusel Coffeecake (no nuts), 20 oz.. packaged in a clear plastic dome/black plastic base
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-0536-2015·2014-12-03
Wehah Farms Organic Brown Rice Flour Recalled for Salmonella
Wehah Farms is recalling 25 lb. bags of Organic Brown Rice Flour due to a positive Salmonella test. The product was distributed in bulk bins in CA, HI, AZ, MA, and NV.
Product
Organic Brown Rice Flour; 25 lb. bulk bags Organic Brown Rice Flour ( UPC # 073416 00500 6) were distributed in retail store bulk bins. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with…
Category
Food
Distribution
5 states
SevereFDA (Devices)·Z-0472-2015·2014-12-03
Toshiba Recalls Cardiac Function Analysis Software Due to Incorrect Results
Toshiba American Medical Systems is recalling two units of cardiac function analysis software because it may display incorrect analysis results for heart function.
Product
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0548-2015·2014-12-03
MaraNatha Organic Raw Creamy Almond Butter Recalled for Salmonella Risk
nSpired Natural Foods is recalling MaraNatha Organic Raw Creamy Almond Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
Product
MaraNatha Organic Raw Creamy Almond Butter, 8 oz., UPC 51651092630; MaraNatha Organic Raw Creamy Almond Butter, 16 oz., UPC 51651092173.
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0271-2015·2014-12-03
Perry Drug Recalls Cyclosporine Eye Drops Due to Sterility Concerns
Perry Drug Inc. is recalling Cyclosporine 0.045% eye drops due to potential sterility assurance issues identified during an FDA inspection.
Product
Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67
Category
Drug
Distribution
2 states
SevereFDA (Food)·F-0540-2015·2014-12-03
nSpired Natural Foods Recalls Almond Butter for Salmonella Risk
nSpired Natural Foods is recalling specific lots of MaraNatha and Whole Foods 365 almond butter due to potential Salmonella contamination.
Product
MaraNatha Roasted Crunchy Almond Butter, 16 oz., UPC 51651092012; Whole Foods 365 Crunchy Almond Butter, 16 oz.., UPC 99482406561.
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0268-2015·2014-12-03
Perry Drug Recalls HCG Injection Vials Due to Sterility Concerns
Perry Drug Inc. is recalling HCG 200 IU/mL Injection vials in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.
Product
HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0275-2015·2014-12-03
Perry Drug Recalls Sodium Tetradecyl Sulfate Injections Due to Sterility Concerns
Perry Drug Inc. is recalling 20 vials of compounded Sodium Tetradecyl Sulfate 0.3% Injection in Kansas and Missouri due to potential sterility assurance issues found during an FDA inspection.
Product
Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
Category
Drug
Distribution
2 states
SevereFDA (Food)·F-0544-2015·2014-12-03
MaraNatha Almond Butter Recalled for Potential Salmonella Contamination
nSpired Natural Foods is recalling MaraNatha No Stir Crunchy Almond Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
Product
MaraNatha No Stir Crunchy Almond Butter, 12 oz., UPC 51651093699.
Category
Food
Distribution
2 states
SevereFDA (Food)·F-0581-2015·2014-12-03
Kerry Breakfast Sausage Seasoning Recalled for Salmonella Contamination
Kerry Foods is recalling 148 bags of Breakfast Sausage Seasoning because an ingredient tested positive for Salmonella.
Product
Item Number B18780.01, Kerry Breakfast Sausage Seasoning, Net WT 50 Lb (22.68 KG), Lot Number: 0407424305
Category
Food
Distribution
6 states
SevereFDA (Food)·F-0579-2015·2014-12-03
Kerry Foods Recalls Sausage Crumble Due to Salmonella Risk
Kerry Foods is recalling specific lots of Sausage Crumble because an ingredient tested positive for Salmonella.
Product
Item Number 30499117.0, Kerry CI 96004320, Sausage Crumble 30499117, 40.05 lbs (18.16 KG) Lot Number : 0401423904
Category
Food
Distribution
6 states
SevereFDA (Drugs)·D-0261-2015·2014-12-03
Perry Drug Recalls Tri-Mix Vials Due to Sterility Assurance Concerns
Perry Drug Inc. is recalling 17 vials of compounded Tri-Mix in Kansas and Missouri due to quality control issues affecting sterility assurance.
Product
Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0284-2015·2014-12-03
Hospira Recalls Normosol-R IV Bags Due to Sterility Concerns
Hospira is recalling 305,664 bags of Normosol-R Multiple Electrolytes Injection due to potential punctures that may compromise sterility and cause leaks.
Product
Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0573-2015·2014-12-03
Karlsburger Foods Recalls Low Sodium Taco Seasoning for Undeclared Milk
Karlsburger Foods is recalling Low Sodium Taco Seasoning because it contains milk, an allergen not declared on the label.
Product
Karlsburger Foods Low Sodium Taco Seasoning, Item Numbers 16423 (Packaged in 23 oz resealable plastic containers), Item #16465 (Packaged in 6.8 lb. resealable plastic containers), and Item #16425 (Packaged in 25 lb. bag in a box).
Category
Food
Distribution
16 states
SevereFDA (Drugs)·D-0276-2015·2014-12-03
Baxter Recalls Heparin Sodium Injection Due to Low Potency
Baxter Healthcare is recalling Heparin Sodium in Sodium Chloride Injection because the raw material was found to have low potency.
Product
HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0263-2015·2014-12-03
Perry Drug Recalls Phenylephrine Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling specific lots of compounded Phenylephrine HCl syringes due to quality control issues affecting sterility assurance.
Product
Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0270-2015·2014-12-03
Perry Drug Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns
Perry Drug Inc. is recalling HCG injections due to quality control issues that may compromise sterility assurance.
Product
2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
Category
Drug
Distribution
2 states
SevereFDA (Food)·F-0560-2015·2014-12-03
MaraNatha Peanut Butter Recalled for Potential Salmonella Contamination
nSpired Natural Foods is recalling MaraNatha No Stir Crunchy Peanut Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
Product
MaraNatha No Stir Crunchy Peanut Butter, 500 grams, UPC 51651093415.
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0287-2015·2014-12-03
Hospira Recalls Sterile Water for Injection Due to Sterility Concerns
Hospira is recalling 153,504 bags of Sterile Water for Injection due to potential punctures that may compromise sterility and cause leaks.
Product
Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0266-2015·2014-12-03
Perry Drug Recalls Tri-mix Antidote Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling Tri-mix Antidote syringes in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.
Product
Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0273-2015·2014-12-03
Perry Drug Recalls Tri Mix Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling Tri Mix PF SYR 0.5 mL Inj. syringes in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.
Product
Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
Category
Drug
Distribution
2 states
SevereFDA (Food)·F-0554-2015·2014-12-03
Safeway Almond Butter Recalled for Potential Salmonella Contamination
nSpired Natural Foods is recalling Safeway Open Nature Creamy Almond Butter Salted due to potential Salmonella contamination. The product was distributed in the US, Canada, and other international locations.
Product
Safeway Open Nature Creamy Almond Butter Salted, 12 oz., UPC 79893113746
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0281-2015·2014-12-03
Hospira Recalls Lactated Ringer's and 5% Dextrose Injection Bags
Hospira is recalling 275,448 bags of Lactated Ringer's and 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.
Product
Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0269-2015·2014-12-03
Perry Drug Recalls HCG Injections Due to Sterility Assurance Concerns
Perry Drug Inc. is recalling HCG 10,000 U/10 mL PF Inj vials in Kansas and Missouri due to quality control issues affecting sterility assurance.
Product
HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0267-2015·2014-12-03
Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns
Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.
Product
HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
Category
Drug
Distribution
2 states
SevereFDA (Food)·F-0572-2015·2014-12-03
Karlsburger Foods Taco Seasoning Recalled for Undeclared Milk Allergen
Karlsburger Foods is recalling specific items of Taco Seasoning because the product contains milk, an allergen not declared on the label.
Product
Karlsburger Foods Taco Seasoning, Item Numbers 43823 (Packaged in 23 oz resealable plastic containers), Item #43807 (Packaged in 7 lb. resealable plastic containers), Item #43825 (Packaged in 25 lb. bag in a box), and Item #43850 (Packaged in 50 lb. bag in a box).
Category
Food
Distribution
16 states
SevereFDA (Drugs)·D-0286-2015·2014-12-03
Hospira Recalls 0.45% Sodium Chloride Injection Due to Sterility Concerns
Hospira is recalling 784,920 bags of 0.45% Sodium Chloride Injection because punctures in the packaging may compromise sterility and cause leaks.
Product
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0282-2015·2014-12-03
Hospira Recalls 5% Dextrose and 0.9% Sodium Chloride Injection Bags
Hospira is recalling 340,272 bags of 5% Dextrose and 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.
Product
5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·14V770000·2014-12-03
Chrysler Recalls 2004-2005 Vehicles Due to Air Bag Inflator Rupture Risk
Chrysler is recalling 2004-2005 Dodge and Chrysler vehicles sold in high-humidity areas because the passenger air bag inflator may rupture during deployment.
Product
DODGE — DODGE, CHRYSLER RAM 3500, RAM 2500, MAGNUM, DURANGO
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0283-2015·2014-12-03
Hospira Recalls Lactated Ringer's Injection Due to Sterility Concerns
Hospira is recalling 6,193,416 bags of Lactated Ringer's Injection because potential punctures may compromise sterility and cause leaks.
Product
Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0279-2015·2014-12-03
Hospira Recalls 5% Dextrose Injection Bags Due to Sterility Concerns
Hospira is recalling 301,560 bags of 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.
Product
5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0278-2015·2014-12-03
Hospira Recalls Potassium Chloride IV Bags Due to Sterility Concerns
Hospira is recalling 836,460 bags of Potassium Chloride IV solution due to potential punctures that may compromise sterility and cause leaks.
Product
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0259-2015·2014-12-03
Perry Drug Recalls Compounded Testosterone Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling compounded Testosterone CYP-250/PROP-20 mg syringes in Kansas and Missouri due to quality control issues affecting sterility assurance.
Product
Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44
Category
Drug
Distribution
2 states
SevereFDA (Devices)·Z-0206-2015·2014-12-03
Philips Medical Systems Recalls Gel-E and Squishon Baby Support Products Due to Mold
Philips Medical Systems is recalling Gel-E Donut and Squishon 2 baby support products because mold was found on the gel-filled items.
Product
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0564-2015·2014-12-03
MaraNatha Peanut Butter Recalled for Potential Salmonella Contamination
nSpired Natural Foods is recalling MaraNatha No Stir Creamy Peanut Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
Product
MaraNatha No Stir Creamy Peanut Butter, 16 oz., UPC 51651092210; MaraNatha No Stir Creamy Peanut Butter, 500 gram, UPC 51651093408.
Category
Food
Distribution
2 states
SevereFDA (Food)·F-0589-2015·2014-12-03
Marathon Ventures Recalls Macadamia Nuts Due to Salmonella Florida Contamination
Marathon Ventures Inc. is recalling various brands of macadamia nuts nationwide due to possible contamination with Salmonella florida.
Product
Macadamia nuts in various formats: (1.) Western Family Macadamia Diced Nuts, Net Wt 5 oz. plastic bags Distributed by:Western Family Foods, Inc. Portland, OR UPC 0 15400 16635 5 (2.) Shur Fine Macadamia Diced Nuts, Net Wt 5 oz. plastic bags. Distributed by:Western Family…
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0260-2015·2014-12-03
Perry Drug Recalls Methyl B12 Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling 186 prefilled syringes of Methyl B12 injection due to potential sterility assurance issues identified during an FDA inspection.
Product
Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0272-2015·2014-12-03
Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns
Perry Drug Inc. is recalling HCG-20,000 U/2 mL vials in Kansas and Missouri due to quality control issues affecting sterility assurance.
Product
HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0262-2015·2014-12-03
Perry Drug Recalls Leuprolide Micro Lupron Kits Due to Sterility Concerns
Perry Drug Inc. is recalling Leuprolide 50 mcg/0.1 mL Micro Lupron Kits in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.
Product
Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
Category
Drug
Distribution
2 states
SevereFDA (Food)·F-0551-2015·2014-12-03
Almond Butter Recalled for Potential Salmonella Contamination
nSpired Natural Foods is recalling specific almond butter products due to potential Salmonella contamination. Consumers should stop using and return the products.
Product
MaraNatha Organic Roasted Creamy Almond Butter, 16 oz., UPC 51651060219; Whole Foods 365 Organic Creamy Almond Butter, 16 oz., UPC 99482405960.
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0264-2015·2014-12-03
Perry Drug Recalls Testosterone Cyp Syringes Due to Sterility Concerns
Perry Drug Inc. is recalling Testosterone Cyp 200 mg/mL syringes due to quality control issues affecting sterility assurance.
Product
Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7906-71
Category
Drug
Distribution
2 states
SevereFDA (Devices)·Z-0226-2015·2014-12-03
Synthes Recalls Titanium Polyaxial Reduction Heads for Spine Screws
Synthes (USA) Products LLC is recalling 24 Titanium Polyaxial Reduction Heads for Matrix Spine Screws because the inner diameter may not have been machined to the correct specification.
Product
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation…
Category
Medical Device
Distribution
3 states
SevereFDA (Drugs)·D-0280-2015·2014-12-03
Hospira Recalls IV Bags Due to Potential Sterility Breach
Hospira is recalling 823,296 bags of 5% Dextrose and 0.45% Sodium Chloride Injection due to potential punctures that may compromise sterility.
Product
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0274-2015·2014-12-03
Perry Drug Recalls Compounded HCG Injections Due to Sterility Concerns
Perry Drug Inc. is recalling compounded HCG injections in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.
Product
HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0265-2015·2014-12-03
Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns
Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.
Product
HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0277-2015·2014-12-03
Hospira Recalls Normosol-R IV Bags Due to Sterility Concerns
Hospira is recalling 152,172 bags of Normosol-R IV solution due to potential punctures that may compromise sterility and cause leaks.
Product
Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0576-2015·2014-12-03
Kerry Foods Recalls Meatball Seasoning Due to Salmonella Risk
Kerry Foods is recalling two meatball seasoning products because they were processed on equipment used for sausage seasoning that tested positive for Salmonella.
Product
Kerry 52-0197-02, , Net Wt 39.7 lbs (18.00 Kg), B18516.01.
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-0474-2015·2014-12-03
Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Potential Result Errors
Abbott Ireland Diagnostics Division is recalling 7,415 ARCHITECT Total T3 Reagent Kits because 17% of specific lots may produce patient results higher than expected.
Product
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0565-2015·2014-12-03
Los Chileros Blue Corn Waffle Mix Recalled for Undeclared Wheat
Los Chileros De Nuevo Mexico is recalling Blue Corn Waffle & Pancake Mix and six other products due to undeclared wheat.
Product
Los Chileros de nuevo mexico gourmet southwestern cuisine Blue Corn Waffle & Pancake Mix, Net Wt. 16 oz (453.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0440-2015·2014-12-03
Intuitive Surgical Recalls 8mm Cardiac Probe Grasper Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Cardiac Probe Graspers because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Food)·F-0569-2015·2014-12-03
Los Chileros Recalls Multiple Southwestern Food Products for Undeclared Wheat
Los Chileros De Nuevo Mexico is recalling seven food products, including Carne Adovada and Sopaipilla Mix, due to undeclared wheat.
Product
Los Chileros de nuevo mexico gourmet southwestern cuisine Carne Adovada with Sopaipilla Mix, 13 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0468-2015·2014-12-03
Summit J700 X-Ray Tube Stand Recalled for Insufficient Welds
Summit Industries is recalling 32 J700 Floor Mounted Tube Stands because insufficient welds may cause breakage, leading to equipment damage or injury.
Product
The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system)…
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0428-2015·2014-12-03
Intuitive Surgical Recalls 8mm Large Needle Driver Instruments
Intuitive Surgical is recalling 509 8mm Large Needle Driver instruments due to potential surface degradation and accelerated mechanical wear caused by reprocessing deviations.
Product
8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0427-2015·2014-12-03
Intuitive Surgical Recalls 8mm Potts Scissors Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 8mm Potts Scissors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0447-2015·2014-12-03
Intuitive Surgical Recalls 8mm Curved Bipolar Dissectors Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Curved Bipolar Dissectors because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Product
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0429-2015·2014-12-03
Intuitive Surgical Recalls 8mm Black Diamond Micro Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Black Diamond Micro Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0485-2015·2014-12-03
Respironics Esprit V1000 Ventilator Recall for Power Supply Defect
Respironics is recalling Esprit V1000 and V200 Conversion Ventilators because incorrect screw installation may cause a short circuit, preventing the switch to battery power during AC outages.
Product
Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0570-2015·2014-12-03
Los Chileros Recalls Multiple Foods for Undeclared Wheat Allergen
Los Chileros De Nuevo Mexico is recalling seven food products, including soups and mixes, due to undeclared wheat.
Product
Los Chileros de nuevo mexico gourmet southwestern cuisine Cream of Green Chile Chicken Soup, 5.92 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2015·2014-12-03
Toshiba Cardiac Function Analysis Software Recalled for Incorrect Results
Toshiba American Medical Systems is recalling one unit of cardiac function analysis software in the US because it may display incorrect analysis results.
Product
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0464-2015·2014-12-03
Vision RT AlignRT System Recalled for Potential Interlock Failure
Vision RT is recalling AlignRT systems due to a potential failure to assert interlock, which could affect radiation safety during treatment.
Product
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Category
Medical Device
Distribution
4 states
HighFDA (Drugs)·D-0285-2015·2014-12-03
Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
Hospira is recalling 16.5 million bags of 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.
Product
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0422-2015·2014-12-03
Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access
Hospira is recalling GemStar infusion pumps because patients are accessing dosage reset codes to change infusion rates set by doctors.
Product
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·14V771000·2014-12-03
Prevost Recalls 2009-2011 Motorcoaches Due to Fire Suppression Tank Defect
Prevost is recalling 80 model year 2009-2011 X3 and XL2 motorcoaches because the fire suppression tank may vent, rendering the system inoperable during a fire.
Product
PREVOST — PREVOST X3, XL2
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0441-2015·2014-12-03
Intuitive Surgical Recalls 8mm Large Hem-O-Lok Clip Applier Devices
Intuitive Surgical is voluntarily recalling 509 units of 8mm Large Hem-O-Lok Clip Appliers due to a Class II device defect. The affected instruments were distributed to facilities in eight US states.
Product
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0419-2015·2014-12-03
Gyrus ACMI Falope-Ring Band Applicator Kits Recalled for Sterile Packaging Compromise
Gyrus Acmi is recalling Falope-Ring Band Applicator Kits due to sterile packaging compromises that could lead to bacterial contamination and patient infection.
Product
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0568-2015·2014-12-03
Los Chileros Recalls Multiple Products Due to Undeclared Wheat
Los Chileros De Nuevo Mexico is recalling seven food products, including cornbread and mixes, because they contain undeclared wheat.
Product
Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Blue Cornbread, 9.84 oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0567-2015·2014-12-03
Los Chileros Recalls Seven Products Due to Undeclared Wheat
Los Chileros De Nuevo Mexico is recalling seven food products, including Santa Fe Chile Seasoning, due to undeclared wheat.
Product
Los Chileros de nuevo mexico gourmet southwestern cuisine Santa Fe Chile Seasoning, 4.5oz (127.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0432-2015·2014-12-03
Intuitive Surgical Recalls 8mm ProGrasp Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 8mm ProGrasp Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0439-2015·2014-12-03
Intuitive Surgical Recalls 8mm Tenaculum Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Tenaculum Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0442-2015·2014-12-03
Intuitive Surgical Recalls 8mm Atrial Retractor Instruments Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Atrial Retractor Short Right instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighNHTSA·14V769000·2014-12-03
Nova Bus Recalls 2012 LFS Transit Buses Due to Seat Anchor Defect
Nova Bus is recalling 2012 LFS transit buses because a seat anchor rivnut may not secure the seat properly, increasing injury risk if the seat detaches.
Product
NOVA BUS — NOVA BUS NOVA LFS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0443-2015·2014-12-03
Intuitive Surgical Recalls 8mm Dual Blade Retractors for Reprocessing Issues
Intuitive Surgical is recalling 509 units of 8mm Dual Blade Retractors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighNHTSA·14V768000·2014-12-03
Temsa Recalls 2014-2015 TS45 Motorcoaches for Headlamp Control Module Malfunction
Temsa is recalling 38 model year 2014-2015 TS45 motorcoaches because a headlamp control module malfunction may cause headlamps and daytime running lamps to fail while driving.
Product
TEMSA — TEMSA TS45
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0446-2015·2014-12-03
Intuitive Surgical Recalls 8mm Clip Appliers Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm clip appliers because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Product
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0473-2015·2014-12-03
Philips IntelliSpace Portal Software Defect May Display Incorrect Cardiac Measurements
Philips is recalling 32 IntelliSpace Portal systems due to a software defect that may display incorrect cardiac and aortic anatomy measurements used for sizing Transcatheter heart valves.
Product
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-0571-2015·2014-12-03
Los Chileros Recalls Multiple Products Due to Undeclared Wheat
Los Chileros De Nuevo Mexico is recalling seven food products, including Green Chile Stew with Tortilla Mix, because they contain undeclared wheat.
Product
Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Stew with Tortilla Mix, 13oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0577-2015·2014-12-03
Kerry Foods Recalls Meatball Seasoning Due to Salmonella Risk
Kerry Foods is recalling two meatball seasoning products because they were processed on equipment used for a product that tested positive for Salmonella.
Product
Kerry 52-0189-02 All Purpose Beef & Chicken Meatball Seasoning, Net WT 43.42 lbs (19.69 Kg) , B18517.01.
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-0421-2015·2014-12-03
Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access
Hospira Inc. is recalling GemStar infusion pumps because patients are using publicly available codes to change infusion rates set by doctors.
Product
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0434-2015·2014-12-03
Intuitive Surgical Recalls 8mm Monopolar Curved Scissors Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Monopolar Curved Scissors because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Product
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
HighFDA (Food)·F-0566-2015·2014-12-03
Los Chileros Sopaipilla Mix Recalled for Undeclared Wheat
Los Chileros De Nuevo Mexico is recalling Sopaipilla Mix and other products due to undeclared wheat, posing a risk to individuals with wheat allergies or celiac disease.
Product
Los Chileros de nuevo mexico gourmet southwestern cuisine Sopaipilla Mix, Net Wt. 12 oz (340 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0435-2015·2014-12-03
Intuitive Surgical Recalls 8mm Resano Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 8mm Resano Forceps instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0467-2015·2014-12-03
Biomerica Recalls Calcitonin ELISA Kits Due to Potential False High Values
Biomerica is recalling Calcitonin ELISA Kits because they may produce false high values. The recall covers 1,062 units distributed worldwide.
Product
Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0425-2015·2014-12-03
Discus Dental Recalls Relief ACP Oral Care Gel Due to Filling Error
Discus Dental LLC is recalling Relief ACP Oral Care Gel because some units were filled with hydrogen peroxide instead of phosphate gel, potentially causing increased sensitivity.
Product
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0574-2015·2014-12-03
Sushi House Inc. Recalls Frozen Raw Yellowfin Tuna Ground Meat
Sushi House Inc. is voluntarily recalling frozen raw yellowfin tuna ground meat because it may contain histamines exceeding 50 ppm.
Product
Frozen Raw Yellowfin Tuna Ground Meat (Thunnus albacares), Grade: AAA, Net Weight: 10 lbs (100%), Wild Caught, Product of Indonesia, Imported and distributed by Heartlight Seafood LLC, 429 SW 195th Ave., Pembroke Pines, FL 33029, Production Date: 06/10/2014, Best used by…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0476-2015·2014-12-03
Dharma Cavity Varnish Recalled for Missing FDA Clearance
Dharma Research, Inc. is recalling Dharma Cavity Varnish 15mL because the product was marketed without a cleared 510(k) submission.
Product
Dharma Cavity Varnish 15mL
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0477-2015·2014-12-03
ZOLL Recalls NeuroFlo Catheter Due to Missing Regulatory Filing
ZOLL Circulation is recalling one lot of NeuroFlo Catheters because a required regulatory supplement was not filed after the company acquired the product's assets.
Product
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0418-2015·2014-12-03
Materialise Recalls Zimmer Patient Specific Instrument PERSONA CR Pin Guides
Materialise USA LLC is recalling specific Zimmer Patient Specific Instrument PERSONA CR Pin Guides because the packaging contained incorrect components and one guide exceeded size specifications.
Product
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0484-2015·2014-12-03
CooperSurgical LEEP Loop Electrode Recalled for Outer Box Mislabeling
CooperSurgical is recalling LEEP Radius Loop Electrodes because the outer box is mislabeled with the wrong part number.
Product
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0465-2015·2014-12-03
Remel Recalls Legionella Pneumo Groups 2-14 Latex Test Kits
Remel Inc is recalling specific lots of the Oxoid Legionella Pneumo Groups 2-14 Latex Test because a reagent may produce false negative results.
Product
Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0424-2015·2014-12-03
Zimmer Recalls Trabecular Metal Tibial Impactor Replacement Pads
Zimmer, Inc. is recalling 4,961 Trabecular Metal Tibial Impactor Replacement Pads due to complaints of pad fracture. The recall provides clarifying instructions for assembly and disassembly.
Product
Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0475-2015·2014-12-03
Dharma Cavity Varnish Recalled for Lack of FDA Clearance
Dharma Research, Inc. is recalling Dharma Cavity Varnish with Fluoride because the product was marketed without a cleared 510(k).
Product
Dharma Cavity Varnish with Fluoride
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0431-2015·2014-12-03
Intuitive Surgical Recalls 8mm Micro Bipolar Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Micro Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Product
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0433-2015·2014-12-03
Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0437-2015·2014-12-03
Intuitive Surgical Recalls 8mm Permanent Cautery Spatulas for Housing Degradation
Intuitive Surgical is recalling 509 units of 8mm Permanent Cautery Spatulas because deviations in reprocessing steps can cause surface degradation of the housing and accelerate mechanical wear.
Product
8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0423-2015·2014-12-03
Zimmer Recalls Trabecular Metal Tibial Impactor Pads Due to Fracture Complaints
Zimmer, Inc. is recalling Trabecular Metal Tibial Impactor Pads to provide clarifying instructions on assembly and disassembly following complaints of pad fracture.
Product
Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Category
Medical Device
Distribution
Distributed nationwide

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